GxP Professional

• 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
• Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQs, TRM.
• Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.
• Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
• Stakeholder management and good executor with required communication.

Candidate must have fair conceptual understanding on below key areas

• IT QMS
• Validation/Qualification
• Risk management.
• Handling of defects/Deviations
• Investigations
• CAPA Handling
• Test Ma...