- Experience Level
- Experienced (non-manager)
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.
We are currently looking to recruit a QA Officer to ensure QA regulatory compliance and product quality requirements are met at all times, to facilitate product release in a timely manner, while maintaining a strong QA culture throughout the business providing guidance as required.
Within this role you will:
- Oversees quality of GMP manufacturing practices (i.e. aseptic practices) and/or analytics during manufacturing/ testing of Drug substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-specific authorisations
- Review Risk Mitigation documentation, validation documents, FMS and Engineering documents, Lab OOS, SOP’s, Policies, and Position Papers.
- Supporting quality related customer complaint investigations and trending activities
- Providing direct quality team support during customer and regulatory audits
- Monitoring the progress of GMP regulated manufacturing and/or GMP analytics processes through all departments to ensure compliance with specifications and GMP.
To succeed, you will bring:
- Previous experience working within Pharmaceutical QA
- Working knowledge of GMP & Quality related pharmaceutical regulations & standards
- 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 Validation and Quality Management systems
- Excellent attention to detail
- Experience of conducting quality based audits, investigations and root cause analysis
- Understanding and experience of Change Control
- Experience of MHRA and or customer /client inspections.
- Experience in document control or records management systems in a regulated environment
- Experience of having worked in a Biologics Manufacturing environment preferable
- Good interpersonal and communication skills
- Good team player, and must also be able to work alone
- Good organisational and time management skills
- Able to prioritise workload, decisive thinker able to work within agreed timescales
- Experience of an Electronic Document Management System to GMP
No agencies please