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 Senior Quality Assurance (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.
Duties & Responsibilities:
Ensure that all manufacturing documentation e.g. BMRs, reports and batch packs are reviewed and approved on batch completion and forwarded to the QP for on time batch release
Review Quality Systems documentation, including Deviations, Change Controls, CAPAs and Risk Assessments
Provide line clearance checks and facility walk arounds
Assist and oversee training of new starters in the Quality team
Ensure that the manufacturing sites follow all SOPs which ensure that health, safety, environmental, quality standards are met
Oversee the quality of GMP manufacturing practices during manufacturing of Vector/Drug Substance to ensure timely release of GMP compliant product in accordance with CTA, IND and site specific authorisations
Provide indirect and/or direct Quality team support during customer and regulatory audits
Monitor the quality of ongoing GMP activities through QA Operations by production of Quality metrics
To succeed, you will bring:
Significant experience working within Pharmaceutical Quality Assurance (QA)
Solid working knowledge of GMP 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 Quality Management Systems and Validation
Significant understanding and experience of GMP pharmaceutical industry QMS compliance requirements
Excellent attention to detail
Proven experience of conducting quality based audits, preferable
Significant experience in quality Risk Assessment investigations and root cause analysis
Proven experience of running an MHRA and or customer /client inspections
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 in accordance with GMP compliance requirements and able to work within agreed timescales
In depth knowledge of relevant GMP regulations and guidelines.
Application closing date Friday 15th November 2020.