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Microbiology QC Manager

Ref: JN-012023-384372

Gepostet am 02 January 2023
Job Location
Geneva
Kategorie
Life Sciences

Join a leader in the pharmaceutical industry as Microbiology QC Manager.

This is a permanent opportunity located in Geneva. 

Your Responsibilities:

  • Direct management of Microbiology QC team.
  • Organize the GMP and safety training of the QC technicians.
  • Approve the QC microbiology samples for incoming raw materials, utilities, environmental monitoring,
  • semi-finish product.
  • Review QC batch records, and microbiology and environmental data.
  • Coordinate QC microbiology laboratory and environmental monitoring activities in classified area (grade B,
  • C and D).
  • Validate microbiology methods as per applicable standards.
  • In case of results out of specification in the classified area, establish the deviation and propose actions to be implemented in the production area.
  • Organize media fill reading and growth promotion test.
  • Organize the utilities monitoring sampling and analysis.
  • Organize the cleaning and maintenance of the QC microbiology instrument/equipment.
  • Organize the management of consumables (from purchasing to incoming control and their storage).
  • Ensure that activities related to the QC microbiology laboratory and environmental monitoring are conform with the company policies, Corporate Quality directives, EP – USP pharmacopoeia.
  • Review/approve for issuance of GMP documents related to QC microbiology laboratory and environmental
  • monitoring (SOP’s, specifications protocols, reports..), and validation/qualification documentation related to QC microbiology equipment.
  • Main contact for QC microbiology laboratory and environmental monitoring during regulatory inspections.
  • Establish compilations and trending of GMP lab data.
  • Could be Lead auditor in self-inspections and external audits.
  • Evaluate any signal detection which could have a potential product quality impact.
  • Diligently report to Head of Quality Unit and Production any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise.
  • Assure a communication flow and collaboration with production, QA, validation, R&D and other functions to assure a product life-cycle quality.

Your Qualifications:

  • Master’s degree in microbiology, Pharmacist, option industry with microbiology modules
  • At least 5 years of experience in pharmaceutical industry
  • French and English spoken and written
  • Extremely motivated, with rigorous work habits and problem-solving skills
  • Quality commitment, flexibility, initiative, cross functional cooperation behavior
  • Excellent motivator, team-spirited leaders with focus on staff performance and operational excellence.

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