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Microbiology Supervisor

Job description

Your new company is looking for a Microbial Supervisor to join their new team and new production plant being set up in Dublin. This is an excellent opportunity for you to join a well-established Pharmaceutical company at important crossroad of the company's history. You will be given the challenge and responsibilities to help lead your new firm's into new sectors within Pharmaceuticals.

RESPONSIBILITIES:

  • Responsible for the overall management of the Microbiology laboratory supporting the manufacture of new product. 
  • Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice always. Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global Company standards.
  • Develop and maintain excellent communication and collaboration between the Microbiology laboratory and other work areas.
  • Supervise Microbiologists including training, recruitment, motivation, discipline and performance appraisal.
  • Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
  • Manage the environmental monitoring programme.
  • Lead and participate in the technical transfer / validation of microbiological testing procedures.
  • Manage contract testing laboratories associated with microbiological testing
  • Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.  Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
  • Manage an effective laboratory documentation system.  The Microbiology Executive will prepare, review and approve documents as required.
  • Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
  • Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
  • Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe always.
  • Generate, implement and control of Microbiology annual budget for consumables, capital and headcount.
  • As required, act as designee for the QC Manager in their absence.
  • Participate as required in global project teams relating to Microbiology and wider quality activities.

GENERAL RESPONSIBILITIES:

  • Participate fully in any cross functional training initiatives.
  • Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP reading, training and assessment.
  • Other duties as required and directed by the Site Quality Head or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:

  • Degree in Microbiology or another relevant field.

RELEVANT EXPERIENCE:

  • More than 7 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
  • Extensive experience of microbiology testing
  • Thorough knowledge of GMP and current FDA & EMEA regulations
  • Previous experience managing the performance of individual team members and the overall team
  • Knowledge and experience of Lean Laboratories is preferable
  • Previous experience in setting up a new Microbiology laboratory is desirable 

SKILLS/COMPETENCIES: 

  • Excellent organizational, communication, interpersonal and report writing skills
  • Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert
  • Demonstrable experience managing, motivating and leading a team

If you believe you have the relevant experience for this role and wish to be considered, apply now or alternatively contact me on 014744692 or sbarrett@sigmar.ie to find out more.