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Executive QC – Quality Control Lead

SUN PHARMA · Halol

🇬🇧 English
QMS cGMP LIMS SAP HANA EDMS Method validation Method transfer EWS Empower LabX

Job description

About the role

Sun Pharma is seeking an Executive – QC to lead quality control activities at its Halol manufacturing site. The role ensures that all pharmaceutical products meet regulatory standards and are released safely and effectively.

Key responsibilities

  • Review and approve QMS documents such as OOS, OOT, lab events, deviations, change controls and CAPA.
  • Validate and sign‑off routine analytical raw data for finished products, APIs, IP, PV and packaging.
  • Maintain site readiness for regulatory inspections and internal audits, implementing corrective actions as required.
  • Ensure compliance with cGMP, regulatory product, process and release procedures.
  • Facilitate internal and external audits, track findings and drive site‑wide corrective actions.
  • Monitor industry trends and identify improvements to the site’s quality assurance system.
  • Review and approve SOPs, analytical COAs, test plans and stability protocols in EDMS and LIMS.
  • Oversee release/approval of raw material and preventive maintenance in SAP HANA.
  • Provide data for quality council, R&D, annual quality review and recall activities.

Required profile

  • Graduate degree in Pharmacy, Chemistry, Biotechnology or related field.
  • Extensive experience in pharmaceutical quality control and regulatory compliance.
  • Strong knowledge of cGMP, QMS and audit processes.
  • Proven ability to lead investigations, root‑cause analysis and CAPA implementation.

Required skills

  • QMS
  • cGMP
  • LIMS
  • SAP HANA
  • EDMS
  • CAPA management
  • OOS/OOT investigation
  • Method validation and transfer
  • Instrument software: EWS, Empower, LabX

What we offer

  • Opportunity to work in a leading global pharmaceutical company.
  • Collaborative environment that encourages continuous learning.
  • Career growth and development aligned with corporate values of pride, accountability, integrity and diligence.

Questions fréquentes

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Published 1 month ago

Expires 2 weeks from now

46 views · 0 interested

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SUN PHARMA

Halol