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Compliance Officer

2 months ago

Oxford, Oxfordshire, United Kingdom Oxford BioMedica (UK) Limited Full time

Join Our Team at Oxford BioMedica (UK) Limited

We are a leading viral vector Contract Development and Manufacturing Organization (CDMO) with a mission to enable our clients to deliver life-changing therapies to patients around the world.

About the Role

We are currently recruiting for a QC Compliance Officer IV to join our Analytical Development and Quality Control (ADQC) Team. The purpose of this role is to ensure timely reporting of analytical data, manage outsourced QC testing, and provide oversight of Good Manufacturing Practice (GMP) compliance.

Key Responsibilities

  • Manage and maintain quality records, including SOPs, certificates, quality reports, samples submission forms, QC testing documents, sampling plans, and other relevant documents.
  • Support the team in client and regulatory agency audits, ensuring compliance with GMP regulations.
  • Manage outsourced QC testing, including vendor selection, contract management, and quality control.
  • Raise and progress Quality Records, including performing calculations for QC Release assays.
  • Manage departmental quality records, ensuring accuracy and completeness.
  • Create, maintain, and check Laboratory Information Management System (LIMS) static data.
  • Manage the implementation and control of Quality Control (QC) processes, ensuring compliance with GMP regulations.
  • Minimum 5 years of experience working within a pharmaceutical regulated environment.
  • Understanding of GMP and knowledge of QC testing within a GMP environment.
  • Understanding of the Quality Management System and reporting structure.
  • Computer literacy, including proficiency in Microsoft Office (Word, Excel, etc.).

What We Offer

  • Highly competitive total reward packages.
  • Wellbeing programs.
  • Development opportunities.
  • State-of-the-art laboratory and manufacturing facilities.

About Us

Oxford BioMedica (UK) Limited is a quality and innovation-led CDMO with a mission to enable its clients to deliver life-changing therapies to patients around the world.