Senior QA Specialist

at  Fresenius Kabi Limited

Overview:
The Company
Fresenius Kabi is a global healthcare company that specialises in 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.
The Fresenius Group employs c.400,000 high-calibre professionals across the world, with a workforce of circa.1,000 professionals across the UK & Ireland.
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. The role is full-time, Monday - Friday and is based in Runcorn.

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 KPI’s 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

Qualifications:

• 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

Benefits

• 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

We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.

• 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 KPI’s 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 control