Prismtech Packaging Solutions Private Limited
Website:
prismtec.com
Job details:
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.
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