Oxford Biomedica's Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with current GMP guidelines. The team are accountable for internal and external audits, quality compliance and control., We are currently recruiting for a Senior QA Officer to join the Operations team within QA. The purpose of the role is to provide expert QA support for Oxford Biomedica Manufacturing Operations.,

• Oversee quality of GMP operations to ensure adequate and timely release of GMP compliant product.
• Ensures that all manufacturing documentation e.g. BMR's, reports are reviewed and approved on batch completion and forwarded to QP for on-time batch release.
• Review quality systems documentation including Deviations, Change Controls and CAPA's.
• Investigate problems in conjunction with Manufacturing / Analytics and other subject matter experts to determine corrective and preventive actions.
• Review Risk Mitigation documentation, validation documents, FMS and Engineering documents, Lab OOS, SOP's, and Policies.
• Supporting quality related customer complaint investigations and trending activities.
• Monitoring the progress of GMP regulated manufacturing and/or GMP analytics processes through all departments to ensure compliance with specifications and GMP.
• Provides line clearance checks including pre-batch manufacture or testing walk rounds at appropriate and quality critical stages of the batch manufacturing / testing process.
• Provide in process quality control to support manufacturing operations and ensure compliance.
• Ensuring the effective communication of key information affecting product release to all relevant parties.
• Support client projects, attending internal and external project meetings and providing quality support from product introduction to commercialisation and beyond.
• Provide direct quality team support during customer and regulatory audits.
  
  A level / National Certificate in Life Sciences or equivalent
• Higher National Certificate or Degree in Life Sciences is desirable.
• Significant experience working within Pharmaceutical QA ideally supporting sterile operations.
• Solid working knowledge of GMP & Quality related pharmaceutical regulations & standards including sterile drug product manufacturing.
• Experience of having worked in an ATMP / Biologics Manufacturing environment preferable.
• Experience of MHRA and or customer / client inspections.
• Previous experience of automation is desirable.
• Computer literate (Word, Excel, MS Office)
  
  At OXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world-and we're looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful, OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. Why Join Us?
• Competitive total reward packages
• Wellbeing programmes that support your mental and physical health
• Career development opportunities to help you grow and thrive
• Supportive, inclusive, and collaborative culture
• State-of-the-art labs and manufacturing facilities
• A company that lives its values: Responsible, Responsive, Resilient, Respect
We want you to feel inspired every day. At OXB, we're future-focused and growing fast. We succeed together-through passion, commitment, and teamwork. Ready to Make a Difference? Collaborate. Contribute. Change lives.