Overview
Our client is seeking an experienced Site Microbiologist to lead and manage the site’s microbiology laboratory. This position defines and drives the microbiology strategy to ensure operational excellence and compliance with all regulatory and quality requirements.
Responsibilities
* Manage the microbiology laboratory and supervise the full microbiology team.
* Act as the primary site contact for all microbiology-related queries and investigations.
* Plan, develop, and implement new projects, systems and process improvements within the microbiology function.
* Serve as the subject matter expert on microbiology, contamination control and Annex 1 requirements.
* Lead and develop microbiology analysts, providing training and performance management.
* Ensure all microbiology operations meet GMP/cGMP, company and environmental health and safety standards.
* Maintain audit and inspection readiness at all times.
* Oversee contamination control strategies, environmental monitoring and method validation/verification.
* Liaise with senior management regarding microbiological issues, risks and strategic planning.
Qualifications & Experience
* Third-level degree in Microbiology (essential).
* Extensive management experience in a high-throughput laboratory within the pharmaceutical industry.
* Strong knowledge of regulatory microbiological methods (USP/Ph.Eur./JP) and method verification/development.
* Expertise in contamination control, bioburden/sterility risk management and Annex 1 compliance.
* Knowledge of steam sterilisation, pharmaceutical water (PW) systems, microbial control and microbial identification methods.
* Excellent leadership, communication and problem-solving skills.
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