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Executive QA – Pharmaceutical Manufacturing

Lupin · Sikkim

Senior 🇬🇧 English
cGMP SOP SAP Process validation Cleaning validation Calibration QAMS eDMS IPQA

Job description

About the role

The Executive – QA will ensure that all manufacturing activities comply with regulatory standards and internal procedures. Working on the shop floor, you will safeguard product quality from raw material receipt through final release.

Key responsibilities

  • Verify compliance with batch records, SOPs and cGMP requirements at every production stage.
  • Perform line clearance, in‑process checks, sampling and stage‑wise batch record reviews.
  • Prepare, execute and compile process performance qualification, cleaning validation and cleaning verification studies.
  • Review master batch manufacturing records and packing records in SAP.
  • Participate in equipment qualification, calibration activities and periodic APQR preparation.
  • Manage CAPA, change controls, OOS, OOT, laboratory incidents, market complaints and deviations through QAMS.
  • Coordinate self‑inspection activities, investigate product or system failures and support batch release.
  • Conduct cGMP training for technicians and handle eDMS and IPQA tasks.

Required profile

  • 6‑9 years of experience in pharmaceutical quality assurance.
  • Graduation in Pharmacy.

Required skills

  • cGMP compliance
  • SOP implementation
  • SAP batch record management
  • Process validation
  • Cleaning validation
  • Equipment qualification and calibration
  • CAPA management
  • QAMS usage
  • eDMS handling
  • IPQA activities

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Published 3 weeks ago

Expires 1 month from now

25 views · 0 interested

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Lupin

Sikkim