Join a leader in the pharmaceutical industry as Microbiology QC Manager.
This is a permanent opportunity located in Geneva.
- 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.
- 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.