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Lead -QMS

Lead -QMS

ConfidentialAurangabad
5 days ago
Job description

Responsibilities

Strategic & Planning :

  • Ensure plant compliance with QMS as per defined guidelines.

Functional / Core :

  • Review production schedules and verify compliance with product-specific requirements.
  • Ensure timely and correct issuance of batch documents.
  • Maintain traceability and reconciliation of all documents; review for non-compliance.
  • Handle destruction of expired documents with proper record-keeping.
  • Ensure all QA documents are fully completed.
  • Implement the SIMPLOUD system effectively across departments.
  • Support QA Manager during internal and external audits.
  • Carry out self-inspections as per QA Manager's guidance.
  • Collaborate with Engineering and Calibration teams for compliance.
  • Handle customer complaints as per procedure.
  • Monitor CAPA (Corrective and Preventive Actions).
  • Maintain, prepare, and review monthly QMS reports.
  • Perform batch release in the absence of the responsible person.
  • Ensure continuity of documentation management in absence of key personnel.

    • Internal Processes :

  • Ensure adherence to regulatory compliance.
  • Maintain cGMP compliance throughout manufacturing.
  • Comply with GMP and process audits.

    • People Development :

  • Train management and plant associates on Good Documentation Practices (GDP).
  • Provide training on compliance with data integrity and online documentation requirements.

    • Skills Required

    Qms, Internal Quality Auditor

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