About the Role

Responsibilities

- Strong hands-on knowledge of Computer System Validation (CSV) in a GxP-regulated manufacturing environment
- Experience with manufacturing equipment and associated computerized systems, including PLC, SCADA, HMI/IPC and shop-floor applications
- Experience in validation and qualification activities such as Risk Assessment, IQ, OQ, PQ, Traceability Matrix and Validation Summary Reports
- Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and Data Integrity
- Exposure to digital manufacturing platforms / digitalization/AI initiatives and integration of shop-floor systems with enterprise applications
- Understanding of LIMS, QMS, MES and other GxP applications
- Experience supporting change controls, deviations, CAPA and regulatory audits
- Ability to work effectively with Manufacturing, Engineering, Quality, IT, Automation and equipment vendors
- Professionals with a strong combination of CSV + Manufacturing Equipment + Digital Platforms are encouraged

Qualifications

- B. Tech

Preferred Skills

- Professionals with a robust combination of CSV + Manufacturing Equipment + Digital Platforms are encouraged

Pay range and compensation package

- up to 8 LPA

📌 Executive (Indore)
🏢 LUPIN
📍 Indore