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Manager QC Microbiology

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 15/02/2018
  • Job reference: J381770A

Manager QC Microbiology

Our client, a leading Biopharmaceutical organisation is currently seeking a Manager QC Microbiology to join their expanding team. The successful candidate will be responsible for the management of a team of analysts within the QC Microbiology department for a cGMP biopharmaceutical manufacturing facility.

Responsibilities

  • Manage a team of analysts within the QC Microbiology department involved in the review of raw materials, intermediates (in process) and bulk drug substance testing in a cGMP regulatory environment.
  • Responsible for all QC microbiological aspects of cGMP compliance and review of sample analysis.
  • 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.
  • Ensures 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 investigations, SOPs and reports.
  • Supports Product Testing and environmental monitoring as required.
  • Oversee and maintain appropriate procedures to ensure chain of custody for QC samples is maintained, as required.
  • Assist in the preparation for internal/customer/regulatory inspections.
  • Ensure a safe working environment within the laboratory.
  • Proactively identifies and implements improvements and lean initiatives.
  • Oversees or conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Ensures that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
  • Presents 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.

Requirements

  • Requires BS/BA in Microbiology or related life sciences discipline and 7+ years of relevant experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or leadership experience.
  • Excellent Communication skills, both verbal & written.
  • Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc, is an advantage.
  • In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations.
  • Adaptable and flexible, willing to travel when needed.
  • Collaborate and foster internal team work with other cross-functional areas and sites.
  • Maintains the highest standards of ethical behaviour.
  • Results orientated and performance driven.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Proficient in the use of Microsoft products including, Excel, Word and PowerPoint.
  • Previous experience with a QC laboratory/ plant start-up would be an advantage.

For more information on this and similar position please contact Kathryn on 01 6455244 or email kathryn.whyte@experis.ie 

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