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Lead Quality, HCM

IndiaFull-time8–10 yrsPosted 1 week ago

Senior pharma role at ACG (ACG World). Needs 8–10 years.

About the role

Responsible for ensuring that the products produced meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to within HCM BU.

What you'll do

  • Drive start-to-end quality strategy, regulatory compliance, process reliability, and continuous improvement across the manufacturing lifecycle
  • Approve URS of each machine to complete customer compliance
  • Conduct FAT with the customers (Domestic / Export) to get acceptance before delivery
  • Approve or reject non-conforming materials and enforce root cause analysis (5 Whys
  • Mentor, train, and evaluate the performance of QA/QC engineers and floor inspectors

What you need

  • Regulatory affairs
  • GMP
  • Documentation
  • ISO 9001
  • Root cause analysis
  • Calibration

Good to have

  • SAP

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