VI
Strong working knowledge of GAMP 5
VARITE INDIA PRIVATE LIMITED
- 🇮🇳 India
- On-site
- 1 day ago
- GxP
- ERP
- FMEA
1 day ago
About The Client:
A global professional services network and part of the Big Four, along with Client, EY, and KPMG, operating across 149 countries worldwide.
Essential Job Functions:
- Execute end-to-end CSV activities (IQ/OQ/PQ) for GxP systems impacted by carveout/separation Author, review, and approve validation deliverables
- Validation Plans, URS, FRS, DDS, Test Scripts/Protocols, Traceability Matrix, and Summary Reports Support validation of newly stood-up standalone systems (ERP, LIMS, MES, QMS, Document Management Systems)
- Validate data migration activities ensuring data integrity (ALCOA+ principles)
- Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, and applicable quality standards Manage change controls, deviations, and CAPAs related to system separation/validation Perform risk assessments (FMEA) for validation planning
- Coordinate with IT, QA, Business, and Project Management teams for validation sign-offs and approvals
Unlock Rewards:Refer Candidates and Earn.
If you're not available or interested in this opportunity, please pass this along to anyone in your network who might be a good fit and interested in our open positions. VARITE offers a Candidate Referral program, where you'll receive a one-time referral bonus based on the following scale if the preferred candidate completes a three-month assignment with VARITE.
Experience Level Bonus Referral:
| 0-2 years | INR 5,000 |
| 2-6 years | INR 7,500 |
| 6+ years | INR 10,000 |
About VARITE: VARITE is a global staffing and IT consulting company providing technical consulting and team augmentation services to Fortune 500 Companies in USA, UK, CANADA and INDIA. VARITE is currently a primary and direct vendor to the leading corporations in the verticals of Networking, Cloud Infrastructure, Hardware and Software, Digital Marketing and Media Solutions, Clinical Diagnostics, Utilities, Gaming and Entertainment, and Financial Services.
Equal Opportunity Employer:
VARITE is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, veteran status, or disability status.
Strong working knowledge of GAMP 5 · VARITE INDIA PRIVATE LIMITED