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Microbiology Shift Manager

Marketplace Group
Job LocationRuncorn
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeB

Job Description

Leading international Pharmaceutical Manufacturer seeks an experienced Microbiology Shift Manager.About the role:Reporting to the Sterility Assurance Manager, the Microbiology Shift Manager will provide quality and operational direction to the Microbiology team. To lead and develop the shift microbiologist and to confirm compliance with GMP and internal Standard OperatingProcedures in accordance with the Quality System. The Microbiology Shift Manager is also required to work in conjunction with production management to ensure compliance status is maintained within the facility.Duties may include:

  • Recruitment, organisation and management of laboratory personnel
  • Ensure all monitoring processes are correct and valid, adhered to and updated as necessary
  • Writing of Standard Operating Procedures relating to job role
  • Ensure all samples are taken and processed appropriately, to monitor level of control within cleanroom
  • Any OOL/OOS or adverse trends are reported to Senior Management immediately as appropriate
  • Perform, co-ordinate and assist in deviation investigations as required
  • Completion of records required in the department; including QMS documents
  • Maintain department training and personnel file
  • Subject matter expert for laboratory testing
  • Run and coordinate continuous improvement projects
  • Growth promotion testing and release of incoming microbiological media
  • Environmental monitoring programme for the facility
  • Evaluation of samples on completion of incubation
  • Sample reconciliation and non-reconciliation investigation
  • Identification of isolates up to species level
  • Conducting investigations into environmental excursions plus coordinate Environmental excursion meetings
  • Collaborate with production shift managers including coordinating daily shift meetings
  • Data input and manage EM data including ensuring data is up to date and complete trend reports in a timely manner
  • Manage chemical testing programme
  • Provide sterility assurance mentoring
Skills and experience:
  • Minimum Degree Microbiology/Related Science with extensive experience in a quality assurance or quality control related role.
  • Previous experience in working within a laboratory or pharmaceutical/microbiology or healthcare industries.
  • Knowledge of GMP/regulatory requirements specifically for manufacturing and control of aseptically produced products.
  • Experience of aseptic operations, product knowledge and team management is desirable.
  • Good communication skills.
  • An evident proactive approach to problem solving

Keyskills :
GMPManufacturingMicrobiologyPharmaceuticalProduction

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