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Quality Systems Specialist

2 months ago

Runcorn UK, Cheshire, United Kingdom Fresenius Kabi UK Full time

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 Quality Systems Specialist, you will be reporting to the QMS Manager and will provide dedicated quality oversite and support across the site. The role is full-time, Monday - Friday and is based in Runcorn.


Responsibilities

  • 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
  • Ensure all QMS activities requiring QA review/input are completed to a high standard within required timeframes
  • Develop and report on quality KPI’s to identify trends and improvements needed
  • Identify, design and deliver GMP training to staff in order to support improved application of GMP/GDP standards
  • Implementation of appropriate risk management policies, procedures, systems, and processes, ensuring evaluation processes are effectively applied across the site
  • Identifying areas of continuous improvement in terms of Quality Culture, Compliance and Site quality systems


Experience/qualifications

  • 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



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.