Job Reference: J5634918
Updated On: 20/05/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior GMP Supervisor to join a leading Biopharmaceutical CDMO based in the Kent area. As the Senior GMP Supervisor you will be responsible for the planning and set-up of a GMP facility, and overseeing all manufacturing activities within the facility ensuring GMP compliance.
Key Duties and ResponsibilitiesYour duties as the Senior GMP Supervisor will be varied however the key duties and responsibilities are as follows:
1. You will ensure that all manufacturing activities are carried out in compliance with GMP, with complete, accurate and detailed records.
2. You will utilise your expertise with Biopharmaceutical processes such as Fermentation or Downstream Processing to lead equipment and process troubleshooting, resolving complicated problems that may not have existing procedures.
3. As the Senior GMP Supervisor, you will utilise a Quality Management System to manage various documentation including Change Controls, Deviations, CAPAs and SOPs.
4. You will contribute to site-wide continuous improvement activities using various tools and methodologies e.g. Six Sigma, Lean etc.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior GMP Supervisor we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science subject e.g. Biochemical Engineering, Bioprocessing, Chemical Engineering, Biotechnology
2. Proven industry experience in a Biopharmaceutical Manufacturing regulated environment, following ISO9001, ISO13485 and cGMP principles.
3. A working knowledge and practical experience with processes such as Fermentation, Downstream Processing and Chromatography.
Key Words: GMP | cGMP | Manufacturing | Biopharmaceutical | Biopharma | Biotechnology | Bioprocessing | Biotherapeutics | Compliance | Documentation | Continuous Improvement | Fermentation | Downstream | AKTA | TFF | Recombinant Proteins | Monoclonal Antinbodies | Upstream | USP | DSP |
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