QC - Microbiology Manager

  • Location

    Limerick, Republic of Ireland

  • Sector:

    Quality, Engineering , Science

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Justin Pankinas

  • Contact email:

    mpgjobs@manpower.ie

  • Job ref:

    BBBH2272_1592253498

  • Published:

    5 months ago

  • Expiry date:

    2020-07-15

Manages the QC Microbiology team and provides critical microbiology support to manufacturing and facilities.

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 re-qualification 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 implements 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 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.
* May be required to work shift.

Education and Experience:

* BS/BA in Microbiology or closely related field with 6+ years' experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years' experience in a leadership role in microbiology laboratory management.
* This is an opportunity to join a team select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more our clients unwavering commitment to combining good science & good business.