We are currently looking on behalf of one of our important clients for a Qualification and Validation Manager. This role is permanent position based in Geneva
- Responsible to maintain our 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)
Your skills :
- First and successful experience with validation and qualification activities. Aseptic manufacturing knowledge is preferred.
- Hands on with aseptic filling equipment and facilities, autoclaves, lab test equipment, HVAC and WFI systems is preferred
- Good knowledge of GMP (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, MES and SAP
Your profile :
- Technical Degree from a University, Engineering School or equivalent in Life Sciences Excellent soft skills
- Fluency in English and French is required for the role
If you wish to apply, please send us your resume in Word format with some references
Contact Anthony Patus : firstname.lastname@example.org