Number of Openings

5

ECMS ID in sourcing stage

520642

Assignment Duration

6 months – 1 Year

Total Yrs. of Experience

6+ Years

Relevant Yrs. of experience

6+ Years

Detailed JD (Roles and Responsibilities)
- 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, PQ's, 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 Management & Compliance
- Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
- Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.

Mandatory skills
- 6+ yrs. of Professional experience and solid 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, PQ's, TRM.
- Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.
- Ensure GxP Comput

📌 GxP (Bengaluru)
🏢 Clifyx
📍 Bengaluru