QC Microbiology expert

The QC Expert Microbiology is responsible for the QC Microbiology operational activities, new equipment implementation and tech transfer/projects related to Drug Substance (DS), In-Process-Control (IPC) testing & release, and Environmental and Utilities Monitoring and control.

The consultant owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.

Key responsibilities :

• Execute Microbiological analytical testing upon request.

• Execute data review for DS/IPC/RM internal and external testing.

• Act a Subject Matter Expert (SME) and Single Point Of Contact (SPOC) for QC Microbiology Laboratory

• Own Environmental Monitoring and Utilities process

• Support the planning of activities and ensure team deliverables are met.

• Author, review, and maintain Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required.

• Define the appropriate microbiology test specifications in compliance with reference documents (USP, Eur. Ph., JP, BLA, and beyond)

• Actively contribute to the introduction of new products: be the point of contact and manage the interface between Analytical Transfer & Validation and QC Microbiology team

• Actively contribute to projects related to the Microbiology field and laboratory, especially new equipment implementation (lab automatization)

• Ensure efficient communication between Quality Assurance, Manufacturing, Supply Chain, Warehouse, Quality Control teams and External Laboratories

• Contribute to health authority inspections, internal and corporate audits, response to observations.

• Own and lead quality events management (deviations, investigations, CAPA, change control...)

• Contribute positively to a strong culture of quality, integrity and ethics in business.

• Act in accordance with legal and compliance requirements and company guidelines

• Other activities upon request.

• Delegation to the Manager of QC Lab Operations.

Your profile:

• Microbiology degree : Master of PhD in Microbiology with at least 10 years of experience within a laboratory environment.

• You have at least 8 years of experience in a GMP environment, in a pharmaceutical or biotechnology company

• Deep knowledge of Microbiological testing, regulations and Pharmacopoeias

• Language: French (fluent) and English (advanced; C1)