Site Microbiologist
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Waterford. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
The Site Microbiologist is responsible for the Management of the Microbiology Lab and defines the microbiology strategy for the site in order to meet Operational and Quality objectives.
The successful person will be managing the full micro team for the site along with reviewing departmental performance and acting as the site main contact for all micro related queries.
Responsibilities:
* Manage and oversee all microbiology-related queries and investigations across the site.
* Act as the main point of contact with senior management regarding matters involving the microbiology team.
* Proactively plan, design, and implement new initiatives, systems, and projects for the microbiology function on an ongoing basis.
* Serve as the subject matter expert for all microbiology-related topics.
* Lead and support the site’s Contamination Control Strategy, ensuring alignment with Annex 1 requirements.
* Mentor, train, and develop microbiology analysts to consistently achieve high standards.
* Provide excellent internal and external customer service while maintaining a focus on quality and cost efficiency.
* Ensure operational schedules are met and all batches are available on time.
* Establish and maintain GMP-compliant, cost-effective systems that guarantee all microbiology work is performed in line with cGMP, Health & Safety, Environmental requirements, and industry best practices.
* Ensure the team is fully prepared for audits and inspections at all times.
Requirements:
* University degree in Microbiology
* Significant management experience in a microbiology laboratory within the pharmaceutical industry.
* Strong knowledge of regulatory requirements, including USP/Ph. Eur/JP harmonised microbiological methods, and expertise in method development/verification to ensure compliance with microbiology regulations.
* In-depth understanding of microbiology and its techniques as applied within the pharmaceutical sector.
* Familiarity with steam sterilisation processes and microbiological media.
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