Level 4 Quality Practitioner
Oxford Biomedica (OXB) is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments to patients. Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
The purspose of this role is to support the Quality Assurance Function to ensure that GxP requirements across the end-to-end product lifecycle are met.
Your responsibilities will include:
- Supports the Quality Assurance team in ensuring that GMP manufacturing and analytical testing is performed in accordance with current standard operating procedures, approved batch records, analytical testing instructions, regulatory, product licence and registered detail requirements.
- Support the Quality Operations & Qualified Person Teams to ensure that all required documentation is place ahead of QP Batch certification and release.
- Ensures Deviations, CAPA and Change Controls are documented in accordance with the site systems and regulatory expectations.
- Ensure Good Documentation Practices and accurate record keeping and documentation is maintained.
- Support Document Management team by issuing, logging & tracking controlled documents.
- Monitor and produce GMP Quality Management Systems metrics.
- Participate in continuous improvement initiatives to enhance working practices.
- Support internal audits to maintain and improve Quality systems.
- Support quality related customer complaint investigations and trending activities.
- Investigate problems in conjunction with other functions (i.e. Manufacturing / Analytics / Engineering / Validation etc.) and other subject matter experts to determine corrective and preventive actions.
- Review Risk Mitigation documentation, validation documents, Engineering documents, SOP’s, and Policies.
- Performing documented gap analysis against regulatory requirements and industry expectations.
To success in this role, you will have:
- Life science degree, with a desire to work in Quality Assurance
- Good interpersonal and communication skills.
- Good at receiving & executing instructions.
- Good team player & have an ability to follow instructions.
- Clear thinker and excellent attention to detail
- Good organisational and time management skills.