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Head of Biosafety (In-vitro)
Sector:
Scientific
Job Type:
Permanent
Location:
Edinburgh, Mid & East Lothian
Exact Salary:
£40000 - £57000 per annum
Date Posted:
15-Jun-2022 02:29 PM
Ref #:
JR21
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Based on the outskirts of Edinburgh, Escape Recruitment are working with a world leading scientific company to recruit a Head of Biosafety (In-Vitro) to lead and manage a team offering Good Manufacturing Practice (GMP) testing services, holding sound knowledge of the Biosafety industry, through Eudralex Vol.4 GMP guidelines. Our client is a dedicated partner within their research field where, through education and research they are raising awareness of livestock well being when it comes to infectious diseases. You will join an experienced team and assist in safety studies, evaluating medicinal products and be involved in the testing of biological test samples associated with products intended for human therapeutic use. The Biosafety In-vitro Division operates a mycoplasma and sterility testing service, and you will hold all necessary scientific and management skills to guarantee that testing operations are optimised to the testing of biological medicinal products.



The role:



  • Guaranteeing the smooth and efficient running of the Biosafety In-vitro department whilst ensuring a quality service in line with regulatory and client expectations.

  • Lead and manage a team of Scientists and Technical Officers to ensure all staff are trained and working to high standards.

  • Work closely with the Quality Division to ensure compliance to GMP and relevant regulations such as European and United States Pharmacopoeias.

  • Acting as Scientist for testing protocols where a GMP compliance statement is required.

  • Responsible for the testing facilities and ensure that they are maintained in a GMP compliant and ready state.

  • To proactively manage the departmental Quality documentation (Deviations, OOS, CAPAs and Change Controls including Validations required in the department)


Experience:



  • Good biological expertise (degree or higher qualification) across scientific disciplines e.g. bacteriology, virology and cell culture.

  • A good working knowledge of current Eudralex Vol 4 GMP guidelines/current MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors for a Sterility and Mycoplasma Testing Facility.

  • Practical experience of regulatory guidelines for mycoplasma and sterility testing

  • Including principles and guidelines of GMP, in relation to contract quality control services.

  • Practical experience of working in GMP environments.

  • Practical experience of managing & monitoring cleanroom environments, as well as leadership and management skills, including project management.

  • Ability to liaise effectively with clients.

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