Job Reference: J5633288
Updated On: 13/05/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Head of Biosafety to join a leading pharmaceutical company based near the Edinburgh area. As the Head of Biosafety you will be responsible for the leadership and management of the Biosafety (In-Vitro) Division and ensuring that science and quality of services are in line with Good Manufacturing Practice (GMP) regulatory guidelines and client expectations.
Key Duties and ResponsibilitiesYour duties as the Head of Biosafety will be varied however the key duties and responsibilities are as follows:
1. As the Head of Biosafety, you will ensure that studies are GMP compliant (e.g. European Pharmacopoeia) by engaging with Quality Department.
2. In your role, you will proactively manage all Deviations, OOSc, CAPAs and Change Controls including Validations required in the department.
3. You will act as Scientist for Biosafety and carry out GMP testing protocols as required.
4. As the Head of Biosafety, you will lead and manage the team, ensuring that all testing operations are optimised to ensure the safe and timely release of biological medicinal products.
Role Requirements1. Relevant degree in a related scientific subject, and also biological expertise across scientific disciplines (i.e. bacteriology, virology, cell culture etc.)
2. Proven industry experience in the understanding of cleanroom classifications and environmental monitoring in accordance with ISO 14644.
3. A working knowledge and practical experience with Eudralex Vol 4 GMP guidelines/current MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors for a Sterility and Mycoplasma Testing Facility.
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