Hartley People Recruitment in partnership with our long-standing client are seeking a highly motivated Site Microbiologist to join their expanding team in the Waterford area.
Key Responsibilities:
- Managing and overseeing all micro queries and investigations across the site.
- Collaborating with senior management to address queries related to the micro team.
- Proactively planning, developing, and implementing new projects and systems for the micro team on an ongoing basis.
- Serving as a subject matter expert on all micro-related matters.
- Supporting and driving the Contamination Control Strategy for the site in accordance with Annex 1 requirements.
- Developing and providing training to the micro analysts on the team to meet the highest standards.
- Ensuring the delivery of customer service (both internal and external) in accordance with quality standards and cost control.
- Guaranteeing that operational schedules are met, with all batches ready as required.
- Establishing GMP-compliant, cost-effective systems and ensuring their operational effectiveness to ensure all Microbiology personnel’s work aligns with the organisation, cGMP, Health and Safety, Best Practice, and Environmental requirements.
- Preparing the team thoroughly for all necessary audits and inspections.
Requirements:
- Extensive managerial experience in overseeing a high-throughput Pharmaceutical laboratory.
- Ability to implement Regulatory USP/Ph.Eur/JP harmonised microbiological methods, ensuring compliance through method verification and development.
- Extensive knowledge regarding microbiology and specific techniques in the pharmaceutical industry, including steam Sterilisation and microbiological media.
- Well-versed in environmental control, monitoring, and validation processes.
- Knowledge of microorganisms, bioburden, and contamination control, particularly in relation to non-sterile inhalation products.
- Background of Pure Water (PW) systems, microbial control, microbial identification methods, and a strong understanding of Contamination Control Strategy and Annex 1 requirements.
Interested? Call Kathryn on Hartley People’s office number 051 878 813 or email your CV
Kathryn@hartleypeople.com.
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