Location: Oxford, GB
Company: oxfordbiom
Contract: 12 month fixed-term contract, 5 days a week onsite at our Cowley facility.
Responsibilities
- Reviewing and approving deviations, CAPAs and change controls within defined timelines.
- Supporting manufacturing teams as a QA partner to ensure GMP compliance during production activities.
- Reviewing batch documentation and supporting preparation for Qualified Person batch disposition.
- Participating in investigations, root cause analysis and risk assessments for quality events.
- Reviewing and approving SOPs, protocols, reports and other GMP documentation.
- Supporting implementation of new manufacturing processes for incoming client programs.
- Contributing to continuous improvement initiatives to strengthen quality systems and operational processes.
Qualifications
- Experience in a GMP-regulated pharmaceutical, biotechnology or similar manufacturing environment.
- Significant experience managing quality events such as deviations, CAPAs and change controls.
- Strong understanding of GMP regulations and regulatory expectations (FDA / EMA).
- Ability to work independently, make sound quality decisions and manage multiple priorities.
- Strong communication skills and the ability to collaborate closely with manufacturing and technical teams.
Benefits
- Competitive total reward packages
- Wellbeing programmes that support 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: Responsible, Responsive, Resilient, Respect
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