CSV Project Manager (F/M)

Updated: April 28, 2024 06:08 AM GMT

Antaes Consulting

Nyon

Location: Nyon

Start date: asap

Workload: 100%, on-site

To join our Life sciences team in Geneva, we are looking for a CSV Project Manager Consultant (F/M).

Your role :
• Coordinate and support the IT compliance
• Take part to the strategy of validation / protocols definition / data integrity,
• Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation),
• Manage the risk analysis and criticality with FMECA/APR/AMDEC methods,
• Manage impact assessments, CAPA, deviations and change control,
• Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new system,
• Implement a Safety database,
• Implement solutions for online data management,
• Insure that requested quality documentation is delivered and closed on time and according to legal GMP requirements.

Your profile :
• Engineer/university degree in Life sciences or similar,
• Minimum 5 years of experience in CSV,
•... More Detail