42 Qa Specialist jobs in Ireland
QA Specialist II
Cork, Munster
Gilead Sciences, Inc.
Posted 11 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**QA Specialist II position in QA Supplier Systems Group, Gilead Sciences Ireland UC Cork**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**The Position**
This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers used by GSIUC involving External audit Management, External Deviations, Quality agreement Management, Supplier introduction approval, Supplier notification assessment and Continuous Supplier monitoring.
This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
**Essential Duties and Job Functions:**
+ Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
+ Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers.
+ Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction.
+ Approval of new supplier and material part numbers within Gilead's product lifecycle management system
+ Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider
+ Review of approval of Supplier appraisal reports
+ External Audit Management
+ Quality agreement Management
+ External Deviation approval
+ Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review
+ Ownership, assessment, and Approval of Supplier/Service provider Notifications including changes and quality issues.
+ External and Internal auditing
+ Support for regulatory and corporate audits.
+ Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
+ Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
+ Review and approval of GMP Deviation investigations and CAPAs if required.
+ Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
+ Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
+ Normally receives very little instruction on routine work, general instructions on new assignments.
**Knowledge, Experience and Skills:**
+ Prior experience in pharmaceutical industry is preferred and experience of making Quality decisions.
+ Experience with working with external suppliers is preferred and ability to act when quality issues are seen.
+ Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
+ Demonstrates working knowledge of quality assurance systems, methods, and procedures.
+ Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
+ Demonstrates audit and investigation skills, and report writing skills.
+ Good verbal, written, and interpersonal communication skills.
+ Proficiency in Microsoft Office applications.
**Typical Education & Experience:**
+ Relevant experience in a GMP environment related field and a BS or MS
**Behaviours:**
+ Positive attitude and enjoys working as part of a team
+ Resilient profile with the ability to deliver in a challenging environment
+ Ability to engage and manage multiple stakeholders to achieve the objective
+ Curious with learning agility
+ Operationally excellent
+ Organised with systematic approach to prioritisation
+ Process orientated to achieve the business objective
**Gilead Core Values:**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**QA Specialist II position in QA Supplier Systems Group, Gilead Sciences Ireland UC Cork**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**The Position**
This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers used by GSIUC involving External audit Management, External Deviations, Quality agreement Management, Supplier introduction approval, Supplier notification assessment and Continuous Supplier monitoring.
This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
**Essential Duties and Job Functions:**
+ Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
+ Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers.
+ Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction.
+ Approval of new supplier and material part numbers within Gilead's product lifecycle management system
+ Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider
+ Review of approval of Supplier appraisal reports
+ External Audit Management
+ Quality agreement Management
+ External Deviation approval
+ Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review
+ Ownership, assessment, and Approval of Supplier/Service provider Notifications including changes and quality issues.
+ External and Internal auditing
+ Support for regulatory and corporate audits.
+ Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
+ Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
+ Review and approval of GMP Deviation investigations and CAPAs if required.
+ Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
+ Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
+ Normally receives very little instruction on routine work, general instructions on new assignments.
**Knowledge, Experience and Skills:**
+ Prior experience in pharmaceutical industry is preferred and experience of making Quality decisions.
+ Experience with working with external suppliers is preferred and ability to act when quality issues are seen.
+ Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
+ Demonstrates working knowledge of quality assurance systems, methods, and procedures.
+ Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
+ Demonstrates audit and investigation skills, and report writing skills.
+ Good verbal, written, and interpersonal communication skills.
+ Proficiency in Microsoft Office applications.
**Typical Education & Experience:**
+ Relevant experience in a GMP environment related field and a BS or MS
**Behaviours:**
+ Positive attitude and enjoys working as part of a team
+ Resilient profile with the ability to deliver in a challenging environment
+ Ability to engage and manage multiple stakeholders to achieve the objective
+ Curious with learning agility
+ Operationally excellent
+ Organised with systematic approach to prioritisation
+ Process orientated to achieve the business objective
**Gilead Core Values:**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
0
QA Regulatory Compliance Specialist
PCI Pharma Services
Posted 28 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
1
QA Warehouse Specialist
Blanchardstown, Leinster
PCI Pharma Services
Posted 17 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
2
QA Warehouse Specialist
PCI Pharma Services
Posted 17 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a **QA Warehouse Specialist** (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
**Summary of Role:**
+ Sampling, approval and release incoming good, packaging materials and product (where required) for use in production.
+ Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
+ Review and Filing of acetates for use in sampling.
+ Identify training needs and conduct staff training as required.
+ Maintenance of sampling documentation and retain samples in archive.
+ Management of the Supplier/Customer Defect (SCD) system.
+ Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD.
+ To liaise with customers/supplier for artwork related queries and management of approval of artwork.
+ Review and approval of Master Packaging Material Specifications.
+ Ensure excellence in Housekeeping.
+ Carry out housekeeping audits and prepare the reports.
+ Raise and close deviations and Corrective/Preventative actions as required.
+ Ensure activities observed are in compliance with the requirements of cGMP.
+ Assist in validation studies as required.
+ Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health and Safety meetings.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Secondary Responsibilities:**
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience:**
**Essential:**
+ At least 1- 3 years' experience in a similar role in pharma industries.
+ Experience in lieu of educational requirements.
+ Proven track record of showing how results were delivered.
+ Capability to work towards set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
3
Principal Regulatory Compliance Specialist
Dublin, Leinster
Oracle
Posted 28 days ago
Job Viewed
Job Description
**Job Description**
Oracle Cloud Infrastructure (OCI) is seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our dynamic team. As a key player in our global organization, you will be responsible for managing audits and assessments, and informing OCI on regulatory changes so that we maintain a high level of compliance and adhere to all relevant regulations, policies, and standards.
We are looking for a Regulatory Compliance Specialist who is looking to grow their career in Cloud. You will be responsible for the support and implementation of scalable audit programs to support Oracle Cloud Infrastructure's growth in regulated markets within the Europe, Middle East, and Africa (EMEA) region with a specific focus on Europe.
The ideal candidate will have the following skills:
· 8+ years audit program management experience with either a "Big 4" accounting firm, or a mid-level accounting firm.
· 4+ years proven experience as a Regulatory Compliance Specialist or similar role.
· Knowledge of industry and regulatory frameworks is preferable, such as ISO 27000 Series, SOC 1, SOC2, ENS, ACN, Cyber Essentials+, EU CoC, TISAX, etc.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal abilities.
· Ability to work collaboratively with cross-functional teams.
· Possess ability to explain complex auditing topics to audiences with no auditing experience.
· Ability to prioritize, manage, and deliver on multiple projects simultaneously and partner with management in support of key initiatives and projects.
· Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-paced environment.
· Superior communication skills (interpersonal, verbal, presentation written, email, tickets, etc.)
Preferred Qualifications:
· JIRA and Confluence experience strongly preferred.
· Professional certification in regulatory compliance (i.e. PMP, PgMP, CISA, CISM, CISSP, CIPP)
#LI-DNI
**Responsibilities**
Responsibilities:
Manage Audits and Assessments:
· Plan, manage, and conduct regular compliance audits with third party auditors.
· Communicate OCI processes and policy to third party auditors effectively.
· Report findings and recommend corrective actions as needed across different stakeholder groups.
· Foster a culture of compliance awareness through regular communication and educational initiatives.
· Effectively communicate in remote working environment over video, phone, email and other tools.
Stay Informed on Regulatory Changes:
· Monitor and stay up-to-date on changes to local, national, and international regulations affecting cloud service providers in EMEA, specifically within Europe.
· Analyze the impact of regulatory changes and provide recommendations to the management team.
· Conduct regular reviews and updates of existing policies to ensure ongoing relevance.
Regulatory Reporting:
· Prepare and submit timely and accurate regulatory reports to relevant authorities in accordance with applicable regulations.
· Work closely with internal teams to gather necessary data and information for reporting purposes.
· Provide clear expectations and direction to security and engineering teams within OCI on audit requirements.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
Oracle Cloud Infrastructure (OCI) is seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our dynamic team. As a key player in our global organization, you will be responsible for managing audits and assessments, and informing OCI on regulatory changes so that we maintain a high level of compliance and adhere to all relevant regulations, policies, and standards.
We are looking for a Regulatory Compliance Specialist who is looking to grow their career in Cloud. You will be responsible for the support and implementation of scalable audit programs to support Oracle Cloud Infrastructure's growth in regulated markets within the Europe, Middle East, and Africa (EMEA) region with a specific focus on Europe.
The ideal candidate will have the following skills:
· 8+ years audit program management experience with either a "Big 4" accounting firm, or a mid-level accounting firm.
· 4+ years proven experience as a Regulatory Compliance Specialist or similar role.
· Knowledge of industry and regulatory frameworks is preferable, such as ISO 27000 Series, SOC 1, SOC2, ENS, ACN, Cyber Essentials+, EU CoC, TISAX, etc.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal abilities.
· Ability to work collaboratively with cross-functional teams.
· Possess ability to explain complex auditing topics to audiences with no auditing experience.
· Ability to prioritize, manage, and deliver on multiple projects simultaneously and partner with management in support of key initiatives and projects.
· Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-paced environment.
· Superior communication skills (interpersonal, verbal, presentation written, email, tickets, etc.)
Preferred Qualifications:
· JIRA and Confluence experience strongly preferred.
· Professional certification in regulatory compliance (i.e. PMP, PgMP, CISA, CISM, CISSP, CIPP)
#LI-DNI
**Responsibilities**
Responsibilities:
Manage Audits and Assessments:
· Plan, manage, and conduct regular compliance audits with third party auditors.
· Communicate OCI processes and policy to third party auditors effectively.
· Report findings and recommend corrective actions as needed across different stakeholder groups.
· Foster a culture of compliance awareness through regular communication and educational initiatives.
· Effectively communicate in remote working environment over video, phone, email and other tools.
Stay Informed on Regulatory Changes:
· Monitor and stay up-to-date on changes to local, national, and international regulations affecting cloud service providers in EMEA, specifically within Europe.
· Analyze the impact of regulatory changes and provide recommendations to the management team.
· Conduct regular reviews and updates of existing policies to ensure ongoing relevance.
Regulatory Reporting:
· Prepare and submit timely and accurate regulatory reports to relevant authorities in accordance with applicable regulations.
· Work closely with internal teams to gather necessary data and information for reporting purposes.
· Provide clear expectations and direction to security and engineering teams within OCI on audit requirements.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
This advertiser has chosen not to accept applicants from your region.
4
Quality & Regulatory Compliance Specialist
Dublin, Leinster
Independent Search Solutions
Posted 10 days ago
Job Viewed
Job Description
My client who is a Large and Diversified Medical Device and Pharmaceutical Distribution business has a role for a Quality & Regulatory Compliance Specialist. I am particularly keen to speak with Quality & Regulatory Talent who are coming from a Distribution environment and have a good understanding of Good Distribution Practice (GDP) but I am open to considering people from a range of Compliance backgrounds (Pharma / Medical Device Sector). You will also ideally be Responsible Person Eligible along with being a qualified Pharmacist. Based in South Dublin this successful business offers good career progression opportunities for a dynamic and hardworking Specialist who wishes to further their career through professional development APPLY TODAY Quality Specialist / Regulatory Specialist / Compliance / Good Distribution Practice / Pharmacist / Pharmacovigilance / Responsible Person / Quality Management Systems / Audits / MDR / IVDR /ISO 9001 / ISO 13485/ South Dublin / Ireland Job Title: Quality & Regulatory Specialist Reports To: Quality & Regulatory Lead (Pharma & Medical Device) Location: South Dublin Offices Package: Permanent / Full Time €45k - €5k Basic (Dependent on Experience & Open to Negotiation) Annual Bonus Pension Parking Canteen Paid Annual Leave Educational Assistance ( Role: The Quality Compliance Pharmacist is responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations. This includes support of Quality Systems, Product Release, Validation, and Supplier Management. The role involves maintaining Regulatory Licenses, Managing Pharmacovigilance and Vigilance Activities, Handling Audits and CAPAs, and ensuring up-to-date Documentation and Training Programs. You will also support compliance with MDR/IVDR, oversees Change Control Processes, and ensures products meet Quality Standards before distribution, working cross-functionally with internal teams and external partners. The position will also support Regulatory, Medical Information and Pharmacovigilance requirements as applicable. Duties and Responsibilities: Quality Management & Compliance: Oversee Good Distribution Practice (GDP) activities for pharmaceutical and medical device products Ensure temperature control and environmental monitoring of storage and distribution areas Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs) Perform risk assessments for distributed products and processes in line with regulatory and company standards Maintain and control documentation, including SOPs, records, and batch release documents Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings Regulatory: Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements Monitor regulatory updates and assess business impact (regulatory intelligence) Review and approve product labelling, promotional materials, and advertising to ensure regulatory compliance Pharmacovigilance & Safety: Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures Validation & System Control: Oversee validation of systems, equipment, and processes involved in distribution Ensure compliance with data integrity Training & Development: Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies Ensure training records are complete and up to date Supplier & Warehouse Oversight: Qualify and manage suppliers and third-party service providers, including audits and performance monitoring Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling Product Release: Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution Change Control: Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts Experience: Qualified Pharmacist Responsible Person eligibility 1-3 Years working in a similar role; Quality, Compliance (Pharma / Medical Device Business) Auditor Certified (e.g., ISO 9001 and/or ISO 13485 or Pharma Equivalent) Strong knowledge of GDP, GMP, MDR, IVDR, and Local Regulatory Framework 1-3 years experience in Regulatory, Medical information or Pharmacovigilance If you would like to be considered for this fantastic opportunity follow the links below and send me your CV. Key Words: Quality Specialist / Regulatory Specialist / Compliance / Good Distribution Practice / Pharmacist / Pharmacovigilance / Responsible Person / Quality Management Systems / Audits / MDR / IVDR / ISO 9001 / ISO 13485 / South Dublin / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place, you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: Pharmacist Quality Specialist Regulatory Specialist Compliance Specialist Good Distribution Practice Quality Audit Pharmacovigilance Benefits: Annual Bonus / 13th Cheque Group Life Assurance Laptop Parking Pension Fund Performance Bonus Work From Home
This advertiser has chosen not to accept applicants from your region.
5
Quality Assurance Associate
Cork, Munster
Life Science Recruitment Ltd
Posted today
Job Viewed
Job Description
Job title:Quality Assurance Associate Location:Bishopstown, Cork. Benefits:Excellent salary, 10% bonus, hybrid working, healthcare and pension. Company: My client, spun out from Munster Technological University (formerly Cork Institute of Technology) in 2015, develops innovative ENT (Ear, Nose, and Throat) medical devices that simplify surgical procedures by enabling treatments to be conducted safely outside the operating roomtypically with just topical anesthesia. Role: You will be responsible for assisting in the maintenance of the Quality Management System (QMS), assist with the management of internal processes and external vendors to ensure product quality. This involves managing supplier relationships, participating in audits, resolving quality issues, driving continuous improvement initiatives and collaborate with various teams to maintain quality across the supply chain. The person in this position must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. Job Requirements: Maintaining the effectiveness of the QMS and making continuous improvements to it. Managing day-to-day QA activities including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements. Responsible for assisting in notified body audits and internal audits. Maintain and coordinate quality system schedules, including: Supplier and internal audits; management review and documentation updates. Support the wider team to ensure product manufacture and testing meets the requirements. Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards. Investigating, analysing, and resolving any product quality problems, including root cause analysis and implementing corrective and preventive actions. Ensuring that incoming materials meet the required specifications and working with the engineering team to address any quality concerns. Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: coordinating investigations between complainants and contract manufacturing sites follow up on corrective actions, when required Support with Significant Changes and Notified Body interactions. Carry out other quality related duties as required, inclusive of updates to procedures, forms, processes and periodic reviews. Education Bachelors degree in engineering or science. Quality certification in ISO 13485 a must. A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organisation. Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR and 21 CFR Part 820. Desirable to have lead auditor certification and/or Regulatory certifications. Proven track record with the ability to successfully manage projects to deadlines. Good Documentation Practice experience. Report & Technical Writing experience. Project Management experience. Strong ability to manage critical projects as part of an interdisciplinary team. Excellent problem solving and communication skills. Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on OR Benefits: Healthcare + Annual Bonus + Pension
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6
Quality Assurance Manager
Dublin, Leinster
ICDS Group
Posted 1 day ago
Job Viewed
Job Description
Quality Assurance & Continuous Improvement Manager Location:Dublin 3 (Head Office) €80,000-€90,000 + Benefits A leading international construction company is seeking a Quality Assurance & Continuous Improvement Manager to join their head office team in Dublin. This role will oversee quality systems across a wide range of major projects, ensuring regulatory compliance and driving best practices throughout the business. Key Responsibilities: Manage and maintain the companys Quality Management System in line with ISO 9001 and EU Construction Product Regulations Develop and implement project-specific quality plans, inspection and test plans, and documentation templates Lead internal and external audits, ensuring corrective and preventative actions are tracked and closed out Collaborate with project teams to embed quality standards from project set-up to final handover Deliver training and guidance to teams across the business on quality processes and requirements Promote continuous improvement by identifying opportunities, leading initiatives, and sharing lessons learned Liaise with consultants, site teams, and supply chain partners to ensure quality expectations are met Ensure full compliance with Irish and European building regulations and relevant legislation Requirements: Degree in Construction, Engineering, or related discipline Minimum 10 years experience in a quality-focused role within the construction industry Strong knowledge of ISO 9001, CE marking, and EU/regulatory compliance Experience implementing and managing QMS across multiple projects Excellent leadership, communication, and organisation skills Willingness to travel to project sites across Ireland and Europe This is an exciting opportunity to take on a strategic role in a well-established company offering a competitive salary, benefits, and genuine long-term progression. Skills: Quality Assurance Quality Control ISO 9001
This advertiser has chosen not to accept applicants from your region.
7
Quality Assurance Analyst
Cork, Munster
Clearstream Fund Centre S.A., Cork Branch
Posted 1 day ago
Job Viewed
Job Description
Build the future of financial markets. Build yours. Ready to make a real impact in the financial industry? At Deutsche Brse Group, we'll empower you to grow your career in a supportive and inclusive environment. With our unique business model, driven by 15,000 colleagues around the globe, we actively shape the future of financial markets. Join our One Global Team! Who we are Deutsche Brse Group is one of the world's leading exchange organisations and an innovative market infrastructure provider. With our products and services, we ensure that capital markets are fair, transparent, reliable, and stable. Together, we develop state-of-the-art IT solutions and offer our IT systems all over the world. Within the Deutsche Brse Group, Clearstream is an international central securities depository (ICSD). It provides post-trade infrastructure and securities services for the international market and 59 domestic markets worldwide, with customers in 110 countries. Cork Your career at Deutsche Brse Group Your area of work The Quality Control Officer is responsible for ensuring the accuracy, consistency, and completeness of regulatory reporting outputs across KIIDs, PRIIPs and ESG domains. This role supports the delivery of high-quality reports by performing detailed quality checks, identifying discrepancies, and driving continuous improvement in data validation and reporting processes. Your responsibilities Perform detailed quality control checks on KIIDs, PRIIPs and ESG reports prior to client delivery, ensuring alignment with regulatory standards and internal quality benchmarks. Identify and document errors, inconsistencies, and missing narratives across reporting outputs. Collaborate with Regulatory Reporting Agents to validate data sources and ensure accurate interpretation of regulatory requirements. Monitor and report on recurring quality issues, contributing to root cause analysis and recommending corrective actions. Support the enhancement of validation tools and processes to reduce false positives and improve reporting accuracy. Maintain quality logs and KPIs to track performance and support post-production reviews. Liaise with internal teams to ensure timely resolution of quality issues and escalate critical findings to management. Assist in the development and implementation of quality assurance procedures and best practices. Participate in assigned training and stay updated on regulatory changes impacting reporting standards. Act and work in compliance with all internal rules and policies. Your profile A minimum of 3 years of post-graduate education, preferably in Finance, Data Management, or a related field At least 2 years of experience in a quality assurance, data validation, or regulatory reporting role Understanding of ESG, KIID, and PRIIPs reporting standards and regulatory frameworks Proficiency in English; additional languages are an asset Advanced Microsoft Excel skills and familiarity with data validation tools Excellent attention to detail and analytical skills Strong communication and interpersonal skills Proactive, solution-oriented mindset with a collaborative approach Ability to work independently and manage multiple priorities
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8
Quality Assurance Analyst
Dublin, Leinster
Hays Specialist Recruitment
Posted 1 day ago
Job Viewed
Job Description
Your new company Our client is seeking a QA Analyst to support Ireland and UK operations, ensuring compliance with standards and regulations, and maintaining audit integrity, supplier quality, and operational controls. Your new role Audit Program Support Plan, execute, and follow up on internal, external, and corporate audits. Maintain audit documentation and ensure timely resolution of findings. Supplier Quality Management Conduct supplier audits and evaluations. What you'll need to succeed Proven experience in quality assurance within medical devices or healthcare technology. In-depth knowledge of ISO ,EU MDR, EU MDD, and UK MDR. Certified Lead Auditor for ISO 13485 or equivalent. Familiarity with supplier management protocols and regulatory compliance. Strong documentation and audit skills. Ability to work independently and collaboratively across regions. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. Hays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be Benefits: 12-month contract
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9