Qc Microbiology Expert

Vor 5 Tagen

Lausanne, Schweiz Expleo Group Vollzeit

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)

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