- 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 placed 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.
Requirements and prospects
- Ability to receive knowledge of the pharmaceutical industry in terms of regulations and compliance.
- Computer literate (Word, Excel, MS Office) · Understanding of GMP and pharmaceutical industry QA requirements.
- 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.
5 x GCSEs at grade 4/C or equivalent including maths, English and Science mandatory. A Level 3 science qualification preferred. Life science degree desirable.
On successful completion of the apprenticeship, candidates will be able to apply for further positions.
About the employer
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.
OXB and its subsidiaries have built a sector-leading lentiviral vector delivery platform (LentiVector®), which we leverage to develop in vivo and ex vivo products both in-house and with partners. OXB has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The company has also entered into a number of partnerships, with Novartis, Sanofi, Sio Gene Therapies (previously Axovant Gene Therapies), Orchard Therapeutics, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, through which it has long-term economic interests in other potential gene and cell therapy products. Most recently, OXB signed a supply agreement with AstraZeneca to expand manufacturing support of the Oxford/AstraZeneca COVID-19 vaccine. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 670 people.
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