42 Assurance Specialist jobs in Ireland

Senior Quality Assurance Specialist Location: Cork Industry: Pharmaceutical Employment Type: Full-Time Our client, a leading global pharmaceutical organization, is seeking a Senior Quality Assurance (QA) Specialist to join their dynamic team. This is a fantastic opportunity for an experienced QA professional to work in a high-impact, compliance-driven environment and play a pivotal role in ensuring product quality throughout the lifecycle. Key Responsibilities: Ensure full cGMP compliance in all project- and product-related activities and systems. Develop and implement quality policies, procedures, and continuous improvement initiatives. Support supplier qualification processes and collaborate closely with Procurement and external partners to ensure quality standards are met. Lead and manage all quality aspects of assigned projects and products, ensuring compliance with regulatory and internal standards. Oversee a broad range of QA-related areas such as: -Raw materials, supplier management, production processes -Specifications, change control, deviations, CAPA -Batch release, cleaning validation, audits, and customer complaints -Quality documentation, stability programs, regulatory compliance Provide quality support for the introduction of new products, including document review and approval. Ensure that all activities comply with Health, Safety, and Environmental standards. Be present on the manufacturing floor to offer real-time support and oversight. Qualifications & Experience: Bachelor's degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering 5 years of QA experience in a GMP-regulated pharmaceutical environment - mandatory Hands-on experience in a GMP operational setting Strong knowledge of GMP standards and regulatory requirements

**Sterility Assurance Specialist**
+ Location: Waterford, Ireland
+ Fixed Term Contract
**About the job**
**About Waterford**
For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.
The Sterility Assurance Specialist will be responsible for developing, implementing, and maintaining sterility assurance programs to ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements. This role will function as the subject matter expert (SME) for aseptic processing, contamination control, and microbiological quality, supporting manufacturing operations, quality systems, and continuous improvement initiatives.
**Main responsibilities:**
+ Develop, maintain, and improve site sterility assurance strategies and contamination control plans.
+ Lead risk assessments for aseptic processes, cleanroom operations, and sterilisation activities.
+ Ensure compliance with relevant guidelines (e.g., EU GMP Annex 1, FDA Guidance for Industry, ISO standards).
+ Provide SME oversight during aseptic processing, media fills, and environmental monitoring trend reviews. Identifying trends or issues and implementing effective action plans.
+ Support deviation investigations, root cause analysis, and CAPA implementation for sterility-related issues.
+ Review and approve protocols and reports for sterilisation validation, cleanroom qualification, and disinfection studies.
+ Review and approve documentation related to aseptic manufacturing, sterilisation, and microbiological controls.
+ Function as point of contact for sterility assurance during internal and external audits and regulatory inspections.
+ Ensure timely identification and communication of sterility-related risks.
+ Establish and monitor KPIs for the sterility assurance program and report on its performance and effectiveness.
+ Drive improvements in aseptic practices, gowning, cleaning, and contamination control procedures.
+ Deliver training and coaching to manufacturing, QC, and QA teams on sterility assurance principles.
+ Monitor emerging regulatory changes and industry best practices to update site procedures accordingly.
**About you**
+ Bachelor's degree (or higher) in Microbiology, Biology, Pharmacy, or related scientific discipline.
+ Extensive experience in sterility assurance, microbiology, or quality assurance within GMP-regulated manufacturing.
+ Experience leading contamination control strategies and aseptic process validations.
+ Demonstrated track record of successful regulatory inspections.
+ Sterilisation validation experience (e.g., autoclave, VHP, gamma irradiation) desirable.
+ Strong knowledge of aseptic manufacturing, microbiology, sterilisation methods, and cleanroom operations.
+ In-depth understanding of quality and technical regulations in a GMP environment.
+ Analytical mindset with ability to interpret complex microbiological data and environmental monitoring trends.
+ Excellent communication and leadership skills to influence cross-functional teams.
+ Strong problem-solving skills and ability to make decisions under pressure.
**Why choose us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career.
+ Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (

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**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ 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:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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

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**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ 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:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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

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**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ 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:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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

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**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ 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:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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

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**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ 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:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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

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
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
· Part of the Batch File Review Team who:
a. Compile batch documents
b. Review batch documents in advance of QP review
c. Work with responsible site to complete corrections
d. Prepare COC for QP
e. Work closely with QP as issues arise and find resolution
· Perform a batch file review for batches manufactured/packed at PCI or in third party company.
· Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
· Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
· Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
· Participating customer meetings - discussion/collection/summary about the necessary quality documentation
· Writing SOPs or Work Instructions
· Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
· 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:
· Degree and/or relevant experience.
· GMP experience
· Good communication skills.
· Steriles experience is desirable.
· Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Minimum 2 yrs years' experience working in Quality Assurance
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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

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
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
· Part of the Batch File Review Team who:
a. Compile batch documents
b. Review batch documents in advance of QP review
c. Work with responsible site to complete corrections
d. Prepare COC for QP
e. Work closely with QP as issues arise and find resolution
· Perform a batch file review for batches manufactured/packed at PCI or in third party company.
· Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
· Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
· Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
· Participating customer meetings - discussion/collection/summary about the necessary quality documentation
· Writing SOPs or Work Instructions
· Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
· 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:
· Degree and/or relevant experience.
· GMP experience
· Good communication skills.
· Steriles experience is desirable.
· Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Minimum 2 yrs years' experience working in Quality Assurance
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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