QC Release & QMS Officer

Fresenius Kabi

  • Runcorn, Cheshire
  • Permanent
  • Full-time
  • 16 days ago
Overview:Are you an attentive Quality Control Officer with QC Release and QMS experiene?Reporting to a QC Shift Team Leader, the QC Release & QMS Officer will be performing split duties between QC Release and QMS. This role is permanent and is full-time, 37.5 hours per week Monday-Friday, 7am - 3pm alternating with 3pm - 11pm on a weekly basis and based in Runcorn.Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients.Our product portfolio included a comprehensive range of IV generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Responsibilities:
  • Split between QC Release and QMS activities
  • Review of all pertinent batch documentation as part of the product release process, to assess whether a product is compliant with a given specification and is fit for purpose
  • Ensure QC related QMS activities (Complaints, Events, CAPA, Change Control) are completed to ensure the requirements of the Fresenius Kabi QMS are met
  • Support investigations of non-conformities that may impact upon the release process, product quality or compliance of the ASU facility
  • Contribute to the continuous improvement of all aspects of the quality system to ensure departmental objectives are met and compliance with regulatory requirements is consistently achieved for the ASU
  • Compilation of Certificates of Conformance as required to fulfil customer needs
  • Operation of the QA databases to support QA in publishing appropriate trends (e.g. KPI’s) within the business
  • Review of master documentation (Worksheets and SOPs) prior to issue
  • Generation and/or review of QC specification documents
  • Ensure incoming products are processed in a timely manner and made available for use with transactions performed on SAP (systems applications processes -stock management) updating status as required
Qualifications:
  • Minimum of a Degree in a life science subject and appropriate experience of working in a QC or QA role
  • QMS experience is essential
  • Experience of aseptic operations is necessary; if possible aided by experience in aseptic compounding activities
  • Very good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide
Benefits
  • No rota'd weekend working and no night shifts
  • 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
  • Healthcare cashback scheme (including dental, optical & alternative therapies)
  • 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.

Fresenius Kabi