Product Quality Specialist
- Contract Type
Our recent successes are driving significant growth. We employ more than 420 people at our current facilities in Oxford and we are planning for further headcount growth over the coming years to facilitate the increased demand for our technology and manufacturing capacity. We are also planning expansion to our facilities to accommodate additional partners and support ongoing technology development.
If this is something you want to be a part of we’d love to hear from you.
Key responsibilities and accountabilities:
- Acting as a quality lead and point of contact for client queries with regards to Oxford BioMedica quality documentation.
- Providing updates to clients upon request with regards to the progress of any ongoing investigations.
- Responsible to ensure that timelines for quality documentation stipulated in client quality agreements are met, reporting any issues to line management.
- Providing direct quality team support during client audits, including follow-up, ensuring that agreed commitments are appropriately tracked and clients updated as required.
- Creation and maintenance of a state of readiness in order to satisfy client expectations during audits and inspections.
- Working in a team in order to prepare and ensure the site systems are compliant and meet GxP and quality expectations.
- Awareness and understanding of Quality Systems in order to support them effectively.
- Actively supporting continuous improvement of Quality Management Systems, representing quality in new client projects to ensure quality is built in as early as possible.
- Reporting on-going progress with QA activities and Deviations to Head of Quality.
- Attending meetings and follow up communications across the Quality Systems team and other departments.
- Timely QA review of technical documentation in line with stipulated deadlines.
Key skills and requirements:
- Working knowledge of GMP, GLP & quality related pharmaceutical regulations & standards
- Experience in client management would be beneficial
- Experience in supporting client audits would be beneficial
- A level or National Certificate in a Science discipline
- Higher National Certificate or Degree in science discipline desirable
- Computer literate (Word, Excel, MS Office)
- Solid working knowledge of Quality Management systems
- Technical knowledge of lentiviral manufacturing and analytical processes would be a distinct advantage
Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
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
*no agencies please*