Compliance Officer
9 hours ago
Role Overview
">- The Process Compliance Officer will work alongside the GMP Manufacturing teams to ensure timely completion of batch related issues, while maintaining compliance with internal and external GMP requirements.
About This Role
">- This role involves leading investigations and root cause analysis into process and facility deviations, conducting regular self-inspections of the Manufacturing department, and organising training sessions on manufacturing SOPs and procedures.
- Oxford Biomedica is a quality and innovation-led viral vector CDMO providing development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors.
- We collaborate with innovative pharmaceutical and biotechnology companies, enabling them to deliver life-changing therapies to patients worldwide.
Key Responsibilities:
">- Lead investigations into process and facility deviations, identifying root causes and implementing corrective actions.
- Conduct regular self-inspections to ensure adherence to GMP standards and identify areas for improvement.
- Develop and implement training programs to enhance staff knowledge and skills in manufacturing SOPs and procedures.
Requirements:
">- Experience working in a GMP pharmaceutical or biotechnology environment.
- Strong understanding of manufacturing documentation, including SOPs, Deviations, Change Controls, Risk Assessments, and CAPAs.
- Competency in Microsoft Office and analytical software.
- Familiarity with Root Cause Analysis techniques and ability to interpret complex data.
What We Offer:
">- A highly competitive salary package, estimated at £55,000 per annum, depending on experience.
- State-of-the-art laboratory and manufacturing facilities.
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