Pharmaceutical Regulatory Affairs Specialist

2 weeks ago

Oxford Oxfordshire, United Kingdom Oxford BioMedica (UK) Limited Full time

We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you.
We are currently recruiting for a QC Compliance Officer III to join the Analytical Development and QC (ADQC) Team. Working office based, the purpose of this role is to ensure timely reporting of analytical data, manage the outsourced QC testing and provide oversight of GMP compliance. The QC Compliance Officer role is office based.
Our AD&QC Team supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.
Creation and QC checking of GMP documentation (e.g. SOPs, certificates, quality reports, samples submission forms, QC testing documents, sampling plans, etc)
Management of outsourced QC testing
Raising and progressing Quality Records (e.g. Performing calculations for QC Release assays
Management of departmental Quality Records
Creating and maintaining LIMS static data
Assisting with the implementation and control of QCO processes
Educated to degree level within Life Sciences and experience working within a pharmaceutical regulated environment.
A good understanding of GMP and knowledge of QC testing within a GMP environment.
Previous experience with Quality Management Systems.
Computer literate (word, excel, MS Office)
Oxford Biomedica is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise
Highly competitive total reward packages
Wellbeing programmes
Development opportunities
State of the art laboratory and manufacturing facilities
We’re future-focused and our business is growing rapidly. Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.
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