Department: Quality Assurance / Validation
Experience: 5–8 Years
Key Responsibilities:
Plan and execute VMP, DQ, IQ, OQ & PQ activities and validation reports.
Handle FAT/SAT, commissioning and qualification activities.
Ensure compliance with cGMP, GAMP 5, FDA, EU GMP & WHO GMP requirements.
Manage deviations, CAPA, change controls and risk assessments.
Review technical drawings, P&IDs;, electrical/software documentation and machine specifications.
Coordinate with Design, Production, Automation, Service, Quality and customers.
Support customer audits, regulatory inspections and customer-site validation.
Prepare SOPs, protocols, reports and maintain validation documentation.

Qualification: B.E./B.Tech. in Mechanical, Electrical, Instrumentation, Automation, Pharmaceutical Engineering or equivalent. M.Pharm./validation certification preferred.

Preferred Experience: Pharmaceutical/packaging machinery, pharma equipment, automation or engineering industry; customer-facing validation experience preferred.

Skills: Validation documentation, DQ/IQ/OQ/PQ, GAMP 5, cGMP, FAT/SAT, CAPA, risk assessment, change control and MS Office.

📌 Validation Engineer (Navi Mumbai)
🏢 Prismtech Packaging Solutions Private
📍 Navi Mumbai