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‍compliance officer

Oxford
Oxford BioMedica Limited
Compliance officer
Posted: 19 January
Offer description

OXB is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world.
OXB 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.
In this role, you willensure compliance of GMP Equipment & Systems within the manufacturing department enabling efficient batch delivery against production schedule in line with GMP, safety and environmental requirements, playing a key part in advancing our mission and making a real difference.
Your responsibilities in this role would be: Generating and reviewing of periodic Asset documentation including audit trails, Asset Folders, and User Access levels Maintaining access control for manufacturing and ensuring trained personnel and host access to support Validation / Engineering activities Supporting in progressing of Validation Lifecycle documents and activities for assets (URS, DQ, RQ, VRRs, CST etc) Generating and updating of asset documentation e.g.
equipment logbooks, SOPs Providing technical support and point of contact for queries / data from internal departments e.g.
Validation and support QMS, and Audits and Client requests Liaising with Equipment & Systems vendors to resolve any technical issues that are identified Executing NPI actions which relate to equipment introduction or modification Supporting the implementation and review of HAZOPs Acting as the subject matter expert where required for QMS and supporting/taking ownership of QMS records for equipment and Systems We are Looking For: A-Level, preferably science based with previous industrial experience Graduate in STEM subject (preferred) Experience working in a GMP environment Experience working with of Cell & Gene therapy manufacturing equipment and systems.
bioreactors, chromatography, clean rooms etc.
Ability to travel across all Oxfordshire sites Willingness to working within Cleanroom environment when required About Us: OXB 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 than30years of experience in viral vectors; OXB collaborates with some of the worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturingexpertisein lentivirus, adeno-associated virus (AAV)and adenoviral vectors.
These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatoryexpertise.
Competitive total reward packages Wellbeing programmes that support your mental and physical health Career development opportunities to help you grow and thrive Supportive, inclusive, and collaborative culture State-of-the-art labs and manufacturing facilities A company that lives its values:?

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