Computer System Validation (CSV) Speciailist

Total Yrs. of Experience*: 10 years

Relevant Yrs. of experience*: 8 years

Detailed JD *(Roles and Responsibilities)

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

Mandatory skills*: Computer System Validation (CSV) skills

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

Domain*: Life Sciences