QC MICROBIOLOGY EXPERT

at  Expleo Group

Overview:
Expleo offers a unique range of integrated engineering, quality and strategic consulting services for digital transformation. At a time of unprecedented technological acceleration, we are the trusted partner of innovative companies. We help them develop a competitive edge and improve the daily lives of millions of people.

Joining Expleogroup means 19,000 employees in 30 countries, with a turnover of €1.4 billion in 2023, but also:

• 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

To support our growth in French part of Switzerland (Vaud), we are looking for a QC Expert Microbiology (H/F)
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 at Incyte QC Bioplant.
The QC Expert owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.

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 BioPlant: 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)

• 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 BioPlant: 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…