58 Quality Specialist jobs in Ireland
Process Improvement Project Engineer
Posted 10 days ago
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Job Description
Senior Quality Assurance Specialist
Posted 1 day ago
Job Viewed
Job Description
Senior Quality Assurance Specialist
Posted 1 day ago
Job Viewed
Job Description
Quality Systems Specialist
Posted 4 days ago
Job Viewed
Job Description
**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 day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ 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.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#LI-MS1
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
Quality Systems Specialist
Posted 4 days ago
Job Viewed
Job Description
**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 day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ 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.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#LI-MS1
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
Quality Systems Specialist
Posted 4 days ago
Job Viewed
Job Description
**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 day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ 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.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#LI-MS1
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
Quality Systems Specialist
Posted 4 days ago
Job Viewed
Job Description
**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 day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ 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.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#LI-MS1
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
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About the latest Quality specialist Jobs in Ireland !
Quality Systems Specialist
Posted 4 days ago
Job Viewed
Job Description
**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 day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ 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.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#LI-MS1
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
Quality Systems Specialist
Posted 1 day ago
Job Viewed
Job Description
Director, Business Performance and Process Improvement
Posted 24 days ago
Job Viewed
Job Description
**About the Role**
We are looking for a dynamic, inspiring, and strategic Transformation Leader to steer our organization through a period of significant change and growth. The ideal candidate will be a charismatic individual who not only envisions the future of our organization but also possesses the ability to motivate and lead our team toward that future. We have a key leadership role open for the Director Business Performance & Process Improvement; Payment Integrity based in Ireland.
_Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin and Letterkenny offices and telecommuting from a home-based office._
**Primary Responsibilities:**
Responsible for the identification of process improvements to support affordability savings through:
+ Develop Clinical Business Performance Improvement Strategy across Optum Health value streams to support an ambitious growth target of medical cost savings
+ Lead on implementing continuous improvements or strategic improvements to lead PI portfolio for Optum Health and support Gross Medical Cost Savings of approximately $ 3 Billion
+ Leadership and strategic planning skills to drive strategic operating model of the business keeping in mind the growth/innovation pillars to support the business
+ Develop and articulate Behavioral Health Payment Integrity Business Process Improvement & Transformation Strategy aligning it with our core values and business goals
+ Lead and inspire a culture of innovation, continuous improvement, and adaptability across all levels of the organization to support an ambitious growth target and medical cost savings
+ Strategize & lead Transformation roadmap to achieve multi year benefits in collaboration with Product, Technology, analytics & Automation leaders
+ Drive organizational change initiatives, ensuring they are strategically aligned, effectively communicated, and successfully implemented
+ Create a high performing process exceeding all KPIs, & SLAs in partnership with Operations, Analytics and automation
+ Ensure operational performance improvements are tracked accurately, by establishing and automating statistical control models for value streams, utilizing internal tools and processes
+ Drive changes to performance metrics in partnership with finance, Analytics, workforce management / industrial engineering and ensuring benefits are accounted in P&L accurately
+ Communicate with Leadership/Senior Leadership about progress, challenges and actions required to remove hurdles
+ Provide guidance and assistance to internal and external (client) partners to ensure programs and strategies are implemented effectively and value realized
+ Collaborate with stakeholders, ability to influence without authority to gain support and buy-in for proposed business process solutions and adherence to team requirements
+ Stay up-to-date with industry trends, emerging technologies, and best practices in business transformation
**Required Qualifications**
+ Bachelor's Degree or Undergraduate degree with equivalent experience in Business Operations, Transformation, Change Management and Strategy
+ Demonstrated ability to develop and implement successful organizational change initiatives
+ Exceptional communication and interpersonal abilities, with the skill to inspire and motivate teams
+ A track record of fostering an inclusive and collaborative work environment
+ Prove track record in managing large scale complex programs within a matrix environment
+ Trained in process improvement and change management programs like Six Sigma, Lean or equivalent degree from reputed university
+ Working knowledge of US health care and payment integrity in specific
**Preferred Qualifications**
+ Six Sigma Black Belt certified with in-depth understanding of LEAN process
+ Knowledge / understanding of CPC coding
**Careers with Optum.** Here's the idea. We built an entire organization around one giant objective; make the health system work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.SM
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © 2024 Optum Services (Ireland) Limited. All rights reserved._