Validation Engineer

Salary up to 7.80 LPA based on current salary and exprience.

Candidate must have experience from Pharmaceutical Industry and should be ready for traveling for site work across Gujarat and India also.

Description:

• Execute CSV activities as per GAMP 5, 21 CFR Part 11, and EU Annex 11
• Prepare and execute validation deliverables:

- Validation Plan / VMP sections

- URS, FS, DS

- Risk Assessments (FMEA / Risk-based)

- IQ, OQ, PQ protocols and reports

• Validate systems such as PLC, Lab Computerized Systems, LIMS, QMS, DMS, ERP, SAP, SaaS and custom applications
• Execute test scripts, collect evidence, and maintain traceability
• Work on multiple client projects simultaneously and meet delivery timelines
• Support internal, client, and regulatory audits (USFDA, EMA, MHRA, WHO, PIC/s
• Participate in client meetings and audit discussions, incl...