The purpose of the role is to oversee the general running of the Microbiology laboratory, Environmental management and the aseptic technique associated with the manufacture of a biologics product.
- Responsible for oversight of the Microbiology laboratory supporting the manufacture of biologics products.
- Oversee aseptic practices (gowning, monitoring, cleaning and related training).
- Perform microbiological testing as required to support operations.
- Perform environmental monitoring as required to support operations.
- Ensure that the Microbiology laboratory is set up and operates in compliance with current
- Good Laboratory Practice / Good Manufacturing Practice at all times.
- Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and standards.
- Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
- Training of microbiology analysts
- Scheduling of microbiologist work via visual management
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- Oversee the environmental monitoring programme for the facility.
- Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
- Oversight of 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.
- 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 at all times.
- As required, act as designee for the Plant Microbiologist in their absence.
- Participate as required in global project teams relating to Microbiology and wider quality activities.
- Degree in Microbiology or other relevant field.
- More than 4 years’ experience working in Microbiology in the pharmaceutical industry preferably in a Biologics company
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
- Thorough knowledge of GMP and current FDA & EMEA regulations
- 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
If you are interested in discussing this further please contact Ryan for a confidential discussion at firstname.lastname@example.org OR014744661
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