Compliance Officer

7 days ago


Runcorn, Halton, United Kingdom Fresenius Kabi Limited Full time
Job Summary

Fresenius Kabi Limited is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.

Key Responsibilities
  • Product Release Process: Review all batch documentation to assess compliance with specifications.
  • Batch Approval: Approve individual batches for release to market or further internal use.
  • Investigation and Resolution: Support investigations of non-conformities that may impact product quality or compliance.
  • Quality System Improvement: Contribute to the continuous improvement of the quality system to ensure departmental objectives are met and regulatory requirements are consistently achieved.
  • Certificate of Conformance: Compile Certificates of Conformance as required to fulfill company responsibilities to customers.
  • Quality Assurance Database Management: Operate the Quality Assurance databases to support QA in publishing trends within the business.
  • Interdepartmental Collaboration: Interface with other departments to ensure the requirements of the Fresenius Kabi QMS are met.
  • Additional Duties: Conduct additional duties as required to support colleagues in the effective execution of their duties.
Requirements
  • Education: Degree in a life science subject or appropriate experience in a quality assurance or control related function within the pharmaceutical/healthcare industry.
  • Experience: Experience of aseptic operations is necessary, with aseptic compounding activities being a plus.
  • Knowledge: Very good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide.
Benefits
  • No Rotating Weekend Work: Enjoy a stable work schedule with no rotating weekend work.
  • Contributory Pension Scheme: Participate in a contributory pension scheme that rises with service.
  • Role-Specific Training: Receive a tailored training and development plan to support your growth.
  • Life Insurance: Enjoy life insurance with a benefit of 4 times your salary in the event of death in service.
  • Holiday Entitlement: Enjoy 25 days of holiday entitlement, rising to 27 days after 5 years of service, with the option to buy or sell holidays.
  • Family-Friendly Benefits: Enjoy maternity, paternity, and adoption leave, as well as professional fees paid.
  • Wellness Initiatives: Participate in bike-to-work schemes, employee assistance programs, and charity fundraising and volunteer days.
  • Onsite Amenities: Enjoy free onsite parking and a subsidised canteen.
  • Employee Recognition: Receive long service awards and blue light card benefits.


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