Quality Assurance Director

1 week ago

Kalwa, India beBeeRegulatory Full time ₹ 16,00,000 - ₹ 20,00,000

Job Summary

This is a Senior Manager Quality Assurance position responsible for leading quality assurance activities, ensuring compliance with regulatory requirements and internal audits.

  • Key Responsibilities:
  • Review and approval of plant documents, including the Quality System Manual, Site Master File, and Technical File.
  • Ensuring timely closure of QMS activities such as Change Control, CAPA, OOS, Deviations, Management Review, and Customer Complaints.
  • Responsible for regulatory, customer, and internal audits compliance and providing justification as required.
  • Continuously review quality control processes, procedures, and capabilities to sustain cost-effective and efficient methods for meeting quality requirements.
  • Approval of contract and sub-contract supplier quality agreements.
  • Timely implementation of CAPA and effectiveness checks.
  • Handling Indian and international regulatory requirements, providing information and answering queries as needed.
  • Managing sterilization and microbiological related activities globally, implementing documentation and process specifications.
  • Providing regulatory updates within the manufacturing plant and marketing team.
  • Supporting customer complaints throughout global suppliers.
  • Approving and rejecting finished products according to specifications.

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