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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 Summary

We are seeking a highly experienced Quality Assurance Specialist to join our team as a Quality Systems Specialist. As a key member of our quality team, you will be responsible for providing 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.
    • Provide support to the site in completion of quality investigations, robust root cause analysis, and relevant CAPA through training and mentoring.
  • Quality Assurance
    • Ensure all QMS activities requiring QA review/input are completed to a high standard within required timeframes.
    • Develop and report on quality KPIs to identify trends and improvements needed.
  • Training and Development
    • Identify, design, and deliver GMP training to staff in order to support improved application of GMP/GDP standards.
  • Risk Management
    • Implementation of appropriate risk management policies, procedures, systems, and processes, ensuring evaluation processes are effectively applied across the site.
  • Continuous Improvement
    • Identifying areas of continuous improvement in terms of Quality Culture, Compliance, and Site quality systems.
Requirements
  • Experienced QA Professional with extensive GMP/QMS experience.
  • Science/pharmacy-based degree (or equivalent).
  • 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.
  • Robust understanding of sterile production.
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.