Process Assurance Specialist

1 day ago


Oxford, Oxfordshire, United Kingdom Oxford Biomedica Full time

GMP Compliance Specialist

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  • This 12-month fixed-term contract role involves working closely with the GMP Manufacturing team to ensure batch-related issues are resolved promptly, while maintaining GMP compliance.

About Our Team

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  • Oxford Biomedica is a pioneering CDMO delivering high-quality viral vector development and manufacturing services.
  • We partner with leading pharmaceutical and biotechnology companies to enable the delivery of life-changing therapies.

Responsibilities:

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  • Investigate and resolve process and facility deviations, ensuring timely completion and GMP compliance.
  • Conduct regular inspections of the Manufacturing department to maintain GMP standards and identify areas for improvement.
  • Develop and implement training initiatives to enhance staff knowledge and skills in manufacturing SOPs and procedures.

Requirements:

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  • Proven 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.

Benefits:

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  • An attractive salary package, estimated at £58,000 per annum, based on experience.
  • Opportunities for professional growth and development in a dynamic industry.


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