3 Pharmacy Operations jobs in Ireland
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.
0
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.
1
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.
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