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Quality Assurance Specialist

2 months ago

Runcorn, Halton, United Kingdom Fresenius Kabi UK Full time
About Fresenius Kabi UK

Fresenius Kabi UK is a leading global healthcare company that specializes 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.

We are a global company with a workforce of circa.1,000 professionals across the UK & Ireland, and we are committed to fostering a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products.

Job Description

We are seeking a Quality Assurance Specialist to join our team in Runcorn. As a Quality Assurance Specialist, you will be reporting to the QMS Manager and will provide dedicated quality oversight and support across the site.

Key Responsibilities
  • Quality Management Systems: Ensure robust and effective change management and deviation management systems are in place to meet regulatory requirements.
  • Quality Investigations: Provide support to the site in completion of quality investigations, robust root cause analysis, and relevant CAPA through training and mentoring.
  • Quality KPIs: Develop and report on quality KPIs to identify trends and improvements needed.
  • GMP Training: Identify, design, and deliver GMP training to staff in order to support improved application of GMP/GDP standards.
  • Risk Management: Implement appropriate risk management policies, procedures, systems, and processes, ensuring evaluation processes are effectively applied across the site.
  • Continuous Improvement: Identify areas of continuous improvement in terms of Quality Culture, Compliance, and Site quality systems.
Requirements
  • Experience: Experienced QA Professional with extensive GMP/QMS experience.
  • Qualifications: Science/pharmacy-based degree (or equivalent).
  • Skills: Strong communication and influencing skills, experience with Change Control, Deviation, and Investigation management, Root cause analysis, and CAPA, experience in the use of Trackwise, experience in Quality Risk Management, and a robust understanding of sterile production.
What We Offer
  • Private Healthcare
  • Contributory Pension Scheme
  • Role-Specific Training and Development Plan
  • Life Insurance
  • 25 Days Holiday (Rises to 27 After 5 Years Service)
  • Maternity, Paternity, and Adoption Leave
  • Professional Fees Paid
  • Bike to Work Scheme
  • Long Service Awards
  • Employee Assistance Programme
  • Free Onsite Parking and Subsidized Canteen
  • Blue Light Card
  • Charity Fundraising & Volunteer Days
  • Company Funded Family Days Out