Description
Computer Systems Validation Consultant (m/w)Start date: as soon as possible
Duration: 3 months
Location: canton Neuchatel
The Validation Consultant performs validation activities in relation with Computer Systems
Validation / Data Integrity aspect. They assure compliance of these activities with cGMP as
well as with internal policies and procedures.
- 2+ years' experience in validation in pharmaceutical manufacturing/laboratory
- environment
- Competent with current FDA and EU regulatory regulations and best practices,
- including GAMP
- Knowledge of Data Integrity guide lines. Practical implementation of data integrity
- guidelines with risk based approach nice to have
- Team player
- Good communication skills in French and English
- Impeccable documentation skills, through knowledge of GMP and GDP
- Assess and categorize computerized systems to determine qualification requirements.
- Determine periodic re-verification requirements of computerized systems forcomputerized systems.
- production and laboratory systems. Execute periodic reviews of validated status for
- Review existing computerized systems documentation to identify any data integrity
- gaps and implement corrective actions.
- Ensure computerized systems are qualified, validated and maintained in compliance
- with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including requirement
- specifications, validation plans, protocols, reports, traceability matrix and summary
- reports.
- Execute qualifications for equipment and systems across the site, in relation with QC,
- production, warehouse.
If you are interested in this position please send me your updated cv to or call me on .
Please also share this opportunity with your network to win an Amazon voucher.
Looking forward to recieving your application.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.