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Senior Microbiology Analyst

Job description

Job Description;

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.

 

Job Responsibilities;

  • 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.

 

 

Requirements;

  • 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 rmalone@sigmar.ie OR014744661

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