Head of Biosafety

5 days ago


Penicuik, United Kingdom CK GROUP Full time

CK Group are recruiting for a Head of Biosafety (In-Vitro), on behalf of a leading veterinary medicines research organisation, based at their site in Edinburgh on a permanent basis.
**About the role**:
The main purpose of the role is to lead and manage a team offering mycoplasma and sterility testing services to ensure that testing operations are optimised, and to ensure GMP compliant testing of biological medicinal products.
**Your responsibilities will include**:

- Ensuring the smooth and efficient running of the Biosafety In-vitro Division ensuring a quality service in line with regulatory requirements and client expectations.
- Leading and managing a small team of Scientists and Technical Officers and ensure all staff are trained and working to the highest professional standards.
- Engaging proactively 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.
- Overseeing testing facilities and ensuring that they are maintained in a GMP compliant and ready state.
**About you**:
To be considered for the position you should ideally have the following skills and experience
- Qualified to a minimum of BSc level in a relevant scientific discipline
- Expertise spanning across scientific disciplines including 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.
- Excellent leadership and management skills.
**The benefits**:
Our client offers opportunities for training and development, as well as the following benefits:

- Competitive pension scheme - employer will contribute up to 15%.
- Group Life Assurance Scheme and an Income Protection Scheme
- 6 weeks annual leave plus 7 days public holidays and a privilege day
- Free access to an Employee Assistance Programme
- Benefits platform offering discounts at various retailers
- On site café.
It is essential that applicants hold entitlement to work in the UK.


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