Pharmaceutical Sterility Assurance Specialist
5 days ago
About the Job:
The Pharmaceutical Sterility Assurance Specialist will be responsible for the development and implementation of pharmaceutical sterility assurance programs across GE Healthcare’s Pharmaceutical Diagnostics business. This role will ensure compliance with regulatory requirements and industry best practices, with a focus on Annex 1.
Key Responsibilities:
- Develop and execute the pharmaceutical sterility assurance strategy, including the generation of new standardised processes and the roll out of pharmaceutical sterility assurance training.
- Manage the pharmaceutical sterility assurance COE team and mentor SMEs at manufacturing sites.
- Support regulatory inspections and internal audits, including responses and site pharmaceutical sterility assurance audits or reviews as necessary.
- Develop programs to continuously improve microbiology testing and test method validation, sterile barrier integrity, and environmental monitoring.
- Lead the knowledge increase of pharmaceutical sterility assurance to non-GxP personnel and develop continuous improvement processes to ensure the overall pharmaceutical sterility assurance program remains current and aligned to regulations.
Requirements:
- Previous pharmaceutical sterility assurance experience and in-depth knowledge of cGMP requirements.
- Demonstrated experience with applying quality & risk management tools and knowledge of regulations and guidelines.
- Ability to comprehend and communicate key regulatory requirements and expectations.
- Proven leadership skills and change agent with energy, passion, and enthusiasm to drive change.
-
Global Sterility Assurance Program Leader
5 days ago
Cork, Cork, Ireland GE Healthcare Full timeJob Description:The Global Sterility Assurance Program Leader will be responsible for the development and implementation of sterilization quality management programs across GE Healthcare’s Pharmaceutical Diagnostics business. This role will ensure compliance with regulatory requirements and industry best practices, with a focus on Annex 1.Key...
-
Global Sterility Assurance Leader PDx
6 days ago
Cork, Cork, Ireland GE Healthcare Full timeGE Healthcare Global Sterility Assurance Leader PDx Cork , Ireland Apply NowAs the Global Sterility Assurance Leader, you'll be responsible for the management and development of Sterility Assurance Programs and ensuring compliance with all sterility assurance regulations and industry best practices with specific emphasis on Annex 1 within Pharmaceutical...
-
Global Sterility Assurance Leader PDx
2 days ago
Cork, Cork, Ireland GE Healthcare Full timeGE Healthcare Global Sterility Assurance Leader PDx Cork , Ireland Apply NowAs the Global Sterility Assurance Leader, you'll be responsible for the management and development of Sterility Assurance Programs and ensuring compliance with all sterility assurance regulations and industry best practices with specific emphasis on Annex 1 within Pharmaceutical...
-
Head of Sterility Assurance and Microbiology
6 days ago
Cork, Cork, Ireland Elusav Recruitment Full timeElusav Recruitment have an amazing opportunity for a Head of Sterility Assurance and Microbiology with a leading global biopharma company in Waterford, Ireland.As the Head of Sterility Assurance and Microbiology you will be responsible for developing and implementing effective strategies and procedures for sterility assurance and microbiology across the...
-
Sterile Manufacturing Technician
5 days ago
Cork, Cork, Ireland BioMarin Pharmaceutical Inc. Full timeThe Sterile Manufacturing Technician will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and...
-
Senior Manager Sterility
2 weeks ago
Cork, Cork, Ireland TN Ireland Full timeSocial network you want to login/join with:Senior Manager Sterility / Microbiology, CorkClient: Stryker Ireland, Ltd.Location: Cork, IrelandJob Category: OtherEU work permit required: YesJob Reference: b14a0dcaa974Job Views: 75Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Work Flexibility: HybridJob Title: Senior Manager, Sterility &...
-
Senior Quality Assurance Specialist
6 days ago
Cork, Cork, Ireland LSC, Life Science Consultants Full timeJob Description:LSC, Life Science Consultants have a great contract opportunity for an Associate Quality Specialist to join a global Biopharmaceutical company in the industry.The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials.About the Project -...
-
Sterile Manufacturing Operations Technician
5 days ago
Cork, Cork, Ireland BioMarin Pharmaceutical Inc. Full timeJob Description:This role plays a critical part in establishing sterile filling operations at our Shanbally facility.The successful candidate will support the start-up of the facility, including attending equipment FATs, developing SOPs and batch records, generating training and qualification programmes, and supporting equipment and process validation...
-
Pharmaceutical Quality Assurance Specialist
6 days ago
Cork, Cork, Ireland Life Science Recruitment Full timeAbout the RoleLife Science Recruitment is currently recruiting for a Pharmaceutical Quality Assurance Specialist. As a key member of our team, you will play a crucial role in ensuring the highest standards of quality and compliance in our clients' facilities.Key ResponsibilitiesCompile and review documentsPrepare reports for review and approvalImplement...
-
Regulated Sterile Production Manager
3 days ago
Cork, Cork, Ireland TN Ireland Full timeThe Regulated Sterile Production Manager will play a critical role in the start-up of our new sterile filling facility. This includes attending equipment FATs, developing SOPs and batch records, generating training and qualification programmes, supporting equipment and process validation activities.About the PositionYou will lead cross-functional teams to...
-
Pharmaceutical Quality Specialist
5 days ago
Cork, Cork, Ireland TN Ireland Full timeAbout the RoleWe're looking for a Pharmaceutical Quality Specialist to join our team at TN Ireland. In this role, you will be responsible for ensuring the highest standards of pharmaceutical production by supporting quality assurance activities across both Drug Substance and Drug Product facilities.Key Responsibilities:Ensure compliance with industry...
-
Associate Quality Specialist
3 weeks ago
Cork, Cork, Ireland LSC, Life Science Consultants Full timeAssociate Quality Specialist (Shift) (BBBH28026) Cork, Republic of IrelandLSC have a great contract opportunity for an Associate Quality Specialist to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical...
-
Associate Quality Specialist
6 days ago
Cork, Cork, Ireland LSC, Life Science Consultants Full timeAssociate Quality Specialist (Shift) (BBBH28026) Cork, Republic of IrelandLSC have a great contract opportunity for an Associate Quality Specialist to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical...
-
Sterile Manufacturing Specialist
1 day ago
Cork, Cork, Ireland BioMarin International Limited Full timeJob DescriptionThis is a highly sought-after opportunity for an experienced Sterile Manufacturing Technician to join our team at BioMarin International Limited.The ideal candidate will have previous experience in a quality-focused, operational GMP environment where attention to detail and commitment to the task at hand is key. Previous GMP Sterile Filling...
-
Pharmaceutical Quality Specialist
6 days ago
Cork, Cork, Ireland Life Science Consultants (LSC) Full timeLife Science Consultants (LSC) has a great contract opportunity for an Analytical Chemist to join a market-leading Biopharmaceutical company based in Ireland.The successful candidate will have 2+ years' experience in a GMP regulated environment, with demonstrated knowledge or proficiency in a compliance or quality role and be ready for their next...
-
Pharmaceutical Quality Assurance Specialist
2 days ago
Cork, Cork, Ireland CareerWise Recruitment Full timeJob OverviewCareerWise Recruitment is seeking a highly skilled QC Chemist to join our client's team in Cork, Ireland. This full-time role involves supporting the testing of finished products across various techniques for solid oral dosage, sterile, and biologic product portfolios.The ideal candidate will have a strong background in analytical chemistry and...
-
QC Sterility Analyst
4 weeks ago
Cork, Cork, Ireland BioMarin Full timeQC Analyst- Sterility Team – 6 months Exciting new role in the newly approved sterility test lab within the QC team at BioMarin. This role will be focused on supporting primary component packaging, microbiology and sterility testing support the new Drug product facility in BioMarin. QC Sterility are a high performing team-based group. The team is...
-
Pharmaceutical Microbiologist
22 hours ago
Cork, Cork, Ireland Complete Laboratory Solutions Full timeAbout Us:Complete Laboratory Solutions is a leading provider of comprehensive laboratory solutions for the pharmaceutical industry. Our team is dedicated to delivering high-quality products and services that meet the evolving needs of our clients.Why Join Us?We offer a competitive salary and benefits package, opportunities for professional development and...
-
Pharmaceutical Contract Specialist
6 days ago
Cork, Cork, Ireland Eli Lilly and Company Full timeWe are Eli Lilly and Company, a leading player in the global pharmaceutical market. As a Pharmaceutical Contract Specialist, you will play a vital role in shaping the future of healthcare by ensuring seamless contract management across our manufacturing network.Your primary responsibilities will include identifying and resolving complex legal issues,...
-
Sterility Assurance Expert
6 days ago
Cork, Cork, Ireland Stryker Ireland Full timeJob OverviewStryker Ireland is seeking a highly skilled Senior Microbiologist to join our team. As a key member of our microbiology team, you will play a crucial role in ensuring the quality and safety of our products. The successful candidate will have a strong background in microbiology and a proven track record of delivering high-quality results in a...