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Quality Assurance Lead
2 months ago
About Fresenius Kabi UK
Fresenius Kabi UK is a leading global healthcare company that specializes in developing and manufacturing lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. Our products and services are used worldwide to help care for critically and chronically ill patients.
We are a global company with a workforce of over 400,000 professionals across the world, with a significant presence in the UK and Ireland. Our company is committed to fostering a workplace free from discrimination, where diversity of experience, perspectives, and background create a better work environment and better products.
About the Role
We are seeking a highly experienced Senior Quality Assurance Specialist to join our team in Runcorn. As a Senior QA Specialist, you will be reporting to the Head of Sterility Assurance & Validation, providing dedicated quality oversight and support across the aseptic production and QC release functions.
Key Responsibilities
- Ensure all QC and production related QMS activities requiring QA review/input are completed to a high standard within required timeframes.
- Provide support to the production and compliance teams in completion of quality investigations, robust root cause analysis, and relevant CAPA through training and mentoring.
- Carry out QA review and approval of production documentation.
- Develop and report on quality KPIs relevant to the production and QC teams, to identify trends and improvements needed.
- Build relationships with the operational staff to support and improve the quality performance.
- Provide QA support on QC led projects and change controls.
Requirements
- Experienced QA professional with extensive GMP experience.
- Science/pharmacy-based degree (or equivalent).
- Strong communication and influencing skills.
- Clean room experience and a robust understanding of aseptic techniques and sterile production.
- Experience with Root cause analysis tools, investigation management, and identification of Smart CAPA.
What We Offer
- Private healthcare.
- Contributory Pension Scheme (rises with service).
- Role-specific tailored training and development plan.
- Life Insurance (4 x salary, death in service).
- 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays.
- Maternity, Paternity, and Adoption Leave.
- Professional fees paid.
- Bike to work scheme.
- Long Service Awards.
- Employee Assistance Programme.
- Free onsite parking and subsidised canteen.
- Blue Light Card.
- Charity Fundraising & Volunteer Days.
- Company funded family days out.
