Excellent opportunity to lead a QC Micro team. Please see below for further details or contact email@example.com
Our client, a global biopharmaceutical company based in Limerick, is now hiring an Supervisor to lead their QC Microbiology team.
Essential Duties and Responsibilities
Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment.
Implement and manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
Responsible for all QC microbiological aspects of cGMP compliance and sample analysis.
Design and oversee microbiological validations as needed for drug substance, in-process controls and buffers.
Manage the design, validation and execution of the clean utilities qualification and requalification program.
Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.
Participate in the investigation and review of alert and action limit investigations as needed and implement corrective action as appropriate.
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 generate 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.
May be required to work shift.
Education and Experience:
BS/BA in Microbiology or closely related field with 5+ years' experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 2+ years' experience in a leadership role in microbiology laboratory management.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.