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.
- 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.
- 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.
- Degree in Microbiology or another relevant field.
- 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
- 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 email@example.com to find out more.