Provides expert microbiology and GMP support to the Quality Manager. This position is responsible for the management of the laboratory, carrying out and managing the daily microbiological testing, ensuring that GMP standards are maintained and ensure compliance to ISO11137.
Embrace and live the Company’s 4-I values (Intensity, Integrity, Innovation & Involvement)
- Management of the laboratory function, including the staff, chemical inventory and budgetary spend
- Ensure the effective performance and continuing development of the laboratory staff by the PMD process
- Ensure that all microbiological testing of products bioburden and endotoxicity e.g. is carried out according to procedures.
- Responsible for the environmental monitoring of the controlled areas, including Class 7 Cleanrooms and ensuring compliance with ISO14644.
- Ensure cleaning of the controlled areas is carried out in accordance with procedures.
- Champion for site GMP. Carry out periodic GMP training for all staff and monitor ongoing compliance.
- Ensure compliance with ISO11137; manage the ongoing bioburden testing of the product families and ensure that all product validations are maintained.
- Produce relevant certification as required.
- Liaise with customers on all microbiological issues.
- Ensure all test methods are reviewed on a regular basis and are compliance with the relevant standards / best practice.
- Some travel required, estimated at <5%.
- Honours degree in microbiology.
- Proven managerial experience.
- Fully conversant in Microsoft Word & Excel.
- Excellent communication and presentation skills.
- Previous experience in the medical device, IVD or pharmaceutical sector.
Non-Negotiable Hiring Criteria:
- Proven experience in and understanding of the requirements of ISO14644 and ISO11137.
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