QMS Lead

4 days ago

BaskaVadodara, India Sun Pharma Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Key responsibilities:

  • Lead investigations of deviations, out-of-specification /Trend (OOS/OOT) results, and other quality events.

  • Ensure timely closure of CAPAs and change controls, and monitor their effectiveness.

  • Ensure QMS elements such as document control, deviation management, CAPA, change control, and audit management are effectively executed.

  • Perform risk assessments related to QC operations and QMS processes.

  • Implement mitigation strategies to reduce quality risks.

  • Coordinate with QA, Production, Regulatory Affairs, and other departments to ensure alignment on quality objectives.

  • Identify opportunities for process optimization and cost-effective quality enhancements.

  • Drive initiatives for QMS improvement and digital transformation.

  • All time readiness for internal and external audits (e.g., regulatory, customer).

  • Coordinate audit responses and ensure timely implementation of corrective actions.

  • Conduct QMS-related training for QC personnel.

  • Promote a culture of quality and continuous improvement across the department.

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