09 Sep
|
VARITE
|
Bengaluru
Company Name: VARITE India Private Limited
About The Client:
A global skilled services network and part of the Big Four, along with Client, EY, and KPMG, operating across 149 countries worldwide.
Essential Job Functions:
- Conduct on-floor walkdowns and interviews with system owners/operators for assigned complex systems (DCS, MES, LIMS, Client, ERP-integrated systems) Review existing validation documentation (URS, DS, RA, IQ/OQ/PQ, periodic review reports) for completeness and currency Assess technical/procedural compliance against 21 CFR Part 11 (audit trail, e-signature, access control), Annex 11, and data integrity principles (ALCOA+) Evaluate SOPs related to system use, change control, backup/restore, and user access management Gap Identification & Risk Classification Document all identified gaps with evidence (screenshots, config extracts, interview notes)
- Classify gaps by risk (High/Medium/Low) using client's risk assessment methodology or standard FMEA approach Identify root cause of gaps (e.g., configuration limitation, missing SOP, lack of periodic review)
How to Apply:
Interested candidates are encouraged to respond/submit their updated resumes, and for additional job opportunities, please visit Jobs In India – VARITE.
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 vendo
📌 CSV Engineer (Bengaluru)
🏢 VARITE
📍 Bengaluru