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