QC Manager - Microbiology

Competitive
Permanent
Limerick
20 May 2020
BBBH759478

QC Manager - Microbiology role available with an excellent biotech in Limerick

Manager QC Microbiology

Excellent QC Microbiology Manager role just in with a global biotech based in Limerick.

Summary: Oversees the laboratory quality control testing of in-process samples, sampling of utilities and manages the environmental monitoring programme. This role requires strong people management skills

Essential Duties and Responsibilities include, but are not limited to, the following:
* Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of intermediates (in process) and bulk drug substance in a cGMP regulatory environment. Distribute work load and monitor progress.
* Manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
* Manages product testing to ensure efficient and compliant operations.
* Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
* Review and approve method protocols, reports and SOPs.
* Assist in the preparation for internal/customer/regulatory inspections.
* Ensure a safe working environment within the laboratory.
* Proactively identify and implement lab process improvements, lean initiatives.
* Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
* Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
* Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.
* Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.

Education and Experience:
* Requires BS/BA in Life Sciences or related field with 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry. Previous supervisory/ leadership experience in a laboratory environment is required.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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