Computer System Validation (CSV) Speciailist

Total Yrs. of Experience*: 10 years

Relevant Yrs. of experience*: 8 years

Detailed JD *(Roles and Responsibilities)

1. Validate IT systems used by our life sciences client
2. Define Project Documentation List
3. Author Validation Plan, Validation Report, and review other system deliverables such as URS, FS, CS/DS, IQ, OQ, PQ, FRA, Test Strategy Plan / Report
4. Ensure data migration is executed in a controlled manner; execute Data Migration Plan / Report
5. Support operational activities such as Change Management, Deviation Management, Periodic Reviews, Retirement, Audits / Inspections
6. Ensure stage gates are adhered to as per client’s project management methodology
7. Provide input on project progression / status to the management team on a periodic basis
8. Flag issues / concerns / challenges related to system validation and operational activities
9. French knowledge is mandatory for at least 2 subcons
10. English knowledge for others

Mandatory skills*: Computer System Validation (CSV) skills

Desired skills*: Deep SDLC knowledge, good communication, Team management

Domain*: Life Sciences