Offre #104519

Qualification & Validation Manager (M/F)

Médicale, Biologie & Pharmacie, Recherche

Description du poste

Mission:

We are looking for a Qualification & Validation Manager (M/F) for one of our international customers in the Geneva area who will directly report to the Head of Quality. As an expert for qualification, validation, and change control activities, the Qualification & Validation Manager (M/F) will support the quality organization in a manufacturing site and will supervise the team of two technicians.

• Contract Type: Permanent

• Occupancy rate : 100%

• When : ASAP or to be agreed

 

 Responsibilities:

- Responsible to maintain the global Validation Master Plan including: Equipments, Utilities, and Premises Qualification, Computer System Validation, Process Validation

- To establish risk assessment and to coordinate Change Control activities mainly for technical and quality aspects for Equipments, Utilities and Premises.

- Oversees validation of production processes, performs statistical analysis, develops validation models, and writes process validation protocols and final packages.

- Serves as liaison/team member with technical and production departments

- Review and develop standard operating procedures in compliance with Good Manufacturing Practice (GMP)

Profil recherché

Profile:

- Technical Degree from a University, Engineering School or equivalent in Life Sciences, (e.g. Pharmacy, Chemistry, engineering or related fields)

- First and successful experience with validation and qualification activities. Aseptic manufacturing knowledge is preferred.

- Hands on with aseptic filling equipment and facilities, autoclaves, HVAC and WFI systems is preferred

- Good knowledge pg GMS (US and Europe)

- Working knowledge of Computer Validation and of statistics as related to process control

- Working understanding of Risk Analysis and Control

- Experience with Deviations and CAPA management system (eg: Trackwise), Documentation Management system, and SAP

- Fluency in English and French is required for the role.

 

Additional information:

- The opportunity to join a well-established and successful company

- A great development perspective and the opportunity to bring and utilize your know-how and expertise

- Competitive remuneration packages

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