Overview:

• Have technical and human support for each project and effective follow-up of your career
• Carry out training to develop professional skills
• Participate in dedicated special events
• Integrate a dynamic team

Responsibilities:

• Define the appropriate microbiology test specifications in compliance with reference documents (USP, Eur. Ph., JP, BLA, and beyond)
• Execute Microbiological analytical testing
• Actively contribute to the introduction of new products at the Bio Plant: 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...)

Qualifications:

• Master degree in Microbiology with at least 8 years of experience within a laboratory environment.

• Strong experience in a GMP environment, in a pharmaceutical or biotechnology company
• Deep knowledge of Microbiological testing, regulations and Pharmacopoeias
• Ability to work in a highly regulated and fast changing environment
• Language: French (fluent) and English (advanced; C1)