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 (India)
🏢 Enzene
📍 India
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