Senior Executive/Assistant Manager - Quality Management System

Enzene Biosciences Ltd.; Pune District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Enzene Biosciences Ltd. in Pune, India, is seeking an experienced QA professional to support US site operations from the Bhosari office, working US shift timings. Reporting to Associate Director Quality, you will lead audit activities and CAPA management to ensure regulatory compliance.

The role requires 5–10 years of QA experience, with MSc/MPharm qualifications, and a proven ability to coordinate with geographically dispersed stakeholders while driving timely corrective actions.

Qualifications

• 5–10 years of experience in QA in pharma or biotech.
• M.Sc or MPharm required.
• Strong knowledge of CAPA and audit processes.
• Experience with vendor audits and internal quality system audits.

Responsibilities

• 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
• Monitor CAPA progress and ensure timely completion
• Ensure effectiveness checks are performed and documented per procedure
• Lead the CAPA Management Review Board
• 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

Skills

Vendor audits

Quality systems

CAPA management

Audit planning

Stakeholder coordination

Education

M.Sc in Life Sciences

MPharm

Job description

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