About the Role:
This role supports US site operations, based out of our Bhosari, Pune (India) office, working in US shift timings.
Reports to: Associate Director Quality
Experience – 5 – 10 years
Qualifications – M.Sc/ MPharm
Role & responsibilities:
Audit Management & Compliance
- Act as QA site representative for vendor/supplier audits
- Plan, schedule, and coordinate client audits (agendas, logistics, documentation)
- Draft audit reports, responses, and client communications
- Track audit observations and follow up on action item closure
- Support internal quality system audits
CAPA System
- Monitor CAPA progress and ensure timely completion
- Ensure effectiveness checks are performed and documented per procedure
- Lead the CAPA Management Review Board
Other
- Perform quarterly trending/analysis of QMS elements to flag risks and improvement areas
- Coordinate with geographically dispersed stakeholders
- Additional responsibilities as assigned by Department Head
Role: Quality Assurance - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Quality Assurance, Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education PG: M.Pharma in Any Specialization, MS/M.Sc(Science) in Any Specialization read more
Key Skills Skills highlighted with ‘‘ are preferred keyskills QMSCapa Audit Report
📌 Senior Executive/Assistant Manager - Quality Management System (Pune)
🏢 Enzene
📍 Pune