Executive/ Asst. Manager- QMS
Core
Lead Quality Management System (QMS) and quality oversight activities for medicines and vaccines manufacturing in India, ensuring safe, compliant, and timely product supply.
Role type
Executive/Assistant Manager, Quality Management System (QMS)
Builds
Medicines and vaccines for patients
Domain
Biopharmaceutical manufacturing (medicines and vaccines)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP operations, QMS documentation management, deviation/incident investigation, CAPA execution, internal audit leadership, KPI tracking, regulatory compliance (Drugs and Cosmetics Act + Schedule M), change control, risk assessment
Preferred skills
Electronic batch records, Manufacturing Execution Systems (MES), SAP quality transactions, root cause analysis, continuous improvement tools, leading quality improvement projects
Technologies
SAP, Manufacturing Execution Systems (MES)
Responsibilities
Provide day-to-day quality oversight of QMS in production and Quality Control; Execute and maintain local QMS processes including change control, CAPA, and risk assessments; Manage QMS documentation lifecycle; Lead investigations into deviations, incidents, and customer complaints; Perform internal audits and inspection readiness reviews; Track KPI targets; Execute gap assessments for regulatory system implementation
Seniority
Senior, hands-on IC
