Sr. Executive – Equipment Validation & Qualification
Job Description:
- Work Location: Pithampur
- Days of working - 6 days
- Shift timings - 9 hrs duty
- Salary - Best in the market
- Benefits - Pf , Mediclaim , Insurance
- Gender: Male
Payroll - Talisman HR Solutions
Role Purpose
Responsible for planning and execution of equipment qualification and validation activities (DQ, IQ, OQ, PQ) for manufacturing and utility systems in compliance with GMP and regulatory requirements.
Key Responsibilities
Validation & Qualification Execution
- Prepare and execute DQ, IQ, OQ, PQ protocols and reports.
- Ensure qualification of manufacturing equipment and utilities.
- Coordinate risk assessments (FMEA / impact assessment).
- Support validation master plan (VMP) preparation and updates.
Equipment & Utility Coverage
Experience in qualification of:
- Reactors, distillation columns, centrifuges, dryers
- Tanks, heat exchangers, pumps
- Process piping systems
- Utilities: HVAC, purified water (PW), WFI, clean steam, compressed air, nitrogen, vacuum systems
Documentation & Compliance
- Ensure compliance with GMP, 21 CFR Part 11 (where applicable), and regulatory guidelines.
- Maintain validation documentation as per audit requirements.
- Handle change control, deviation and CAPA related to validation activities.
- Support regulatory audits and inspections.
Cross-Functional Coordination
- Coordinate with Engineering, Production, QA, QC and Automation teams.
- Review P&IDs, layouts and URS documents.
- Support FAT, SAT and commissioning activities from validation perspective.
Qualifications & Experience
- B.E./B.Tech in Chemical / Mechanical OR M.Pharm / B.Pharm
- 5–8 years of experience in Pharma / API manufacturing
- Strong experience in equipment and utility qualification
Key Skills
- Strong knowledge of GMP and validation lifecycle
- Documentation and protocol writing expertise
- Good understanding of process equipment and utilities
- Audit readiness and regulatory exposure
Name - Willita Prashant Ved
Mail ID - Share your CV at: sourcing@talismanstaffing.com
Contact Number - 77100 64829
Company Profile
MNC ---ceutical industry, the discovery, development, and manufacture of drugs and medications
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.