Qualification & Validation Manager
Kelly Scientific is looking for its Life Science partner a Qualification & Validation Manager - Permanent position
- Be responsible to maintain our client's global Validation Master Plan including: Equipments, Utilities, and Premises Qualification, Computer System Validation, Process Validation
- Establish risk assessment and to coordinate Change Control activities mainly for technical and quality aspects for Equipments, Utilities and Premises.
- Oversee validation of production processes, performs statistical analysis, develops validation models, and writes process validation protocols and final packages.
- Serve as liaison/team member with technical and production departments
- Review and develop standard operating procedures in compliance with Good Manufacturing Practice (GMP)
- Technical Degree from a University, Engineering School or equivalent in Life Sciences, (e.g. Pharmacy, Chemistry, engineering or related fields)
- Significant experience with validation and qualification activities
- Hands on with aseptic filling equipment and facilities, autoclaves, 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, and SAP
- Fluency in English and French is required for the role
Your contact at Kelly Scientific
Consultant Life Sciences
Kelly Services® is a global leader in providing staff solutions and active in more than 40 countries.
Together with its subsidiaries, Kelly offers a wide variety of outsourcing and consulting services as well as staff services,
from permanent and management positions to temporary positions.
For over 70 years, we have worked with passion and commitment to connect talents with companies.
With more than 200 employees in over 40 branches and specialist departments,
Kelly Services (Switzerland) AG has been active in Switzerland since 1979.