Job description
Job :
You will ensure the completion and reliability of microbiological analyses of raw materials, work in progress, and finished products, as well as the microbiological monitoring of production environments, in strict compliance with regulatory requirements (GMP, Pharmacopoeias, ISO).
Key Responsibilities
- Perform microbiological analyses: germ counts, search for specific germs, sterility tests, endotoxins (LAL).
- Ensure microbiological control of water, air, surfaces, and personnel.
- Prepare and control culture media (sterility, fertility).
- Conduct tests according to validated methods (Ph. Eur., USP, ISO).
- Ensure traceability of samples and results (LIMS).
- Perform environmental monitoring of production areas (class D) and analyze trends.
- Participate in OOS/OOT investigations, CAPA, and SOP updates.
- Contribute to the maintenance, qualification, and metrology of laboratory equipment.
- Strictly apply HSE, hygiene, and biological safety rules.
Required profile :
- Education: Bachelor's degree +3 in microbiology, biology, biotechnology, or pharmacy.
- Experience: Minimum 3 years in a pharmaceutical or food industry laboratory in a GMP environment.
- Technical skills: membrane filtration, seeding, incubation, LAL, microbial identification.
- Knowledge: GMP, European Pharmacopoeia, ISO 17025.
- Tools: LIMS, Excel, microbiological monitoring software.
- Languages: fluent French
- Qualities: rigor, organizational skills, team spirit, responsiveness, and adherence to procedures.