Consultant - CSV - Life Sciences (PAN India Location)
Summary
CSV consultant at a large IT consulting MNC serving pharma/life-sciences clients across PAN India (hybrid). Day to day: computerized system validation deliverables, risk assessments, audits and quality/compliance work under 21 CFR Part 11, GxP and GAMP 5, validating systems like SAP/S4 HANA, TrackWise, QMS and DMS.
This opportunity is with India's leading IT Technology and consulting MNC for Hybrid work mode (PAN India Locations).
Role Overview
We are looking for experienced professionals with expertise in Computerized System Validation (CSV), Risk Management, Quality and Regulatory Compliance within the Pharmaceutical / Life Sciences industry.
The ideal candidate should have a strong understanding of pharmaceutical regulations, hands-on experience in validation activities, risk assessments, audits and quality management processes.
Key Responsibilities & Requirements
- Experience in the Life Sciences / Pharmaceutical industry, ith consulting services or industry exposure.
- Strong understanding of pharmaceutical compliance regulations, including 21 CFR Part 11, GxP and GAMP 5.
- Experience in creating, reviewing and approving / acknowledging CSV validation deliverables.
- Knowledge of risk management processes and quality management requirements for IT projects.
- Experience in validation of enterprise applications such as SAP / S4 HANA, TrackWise, QMS, DMS, etc.