Job Description

Summary

This role will support Quality Assurance and Regulatory Affairs activities, ensuring compliance with cGMP/cGxP requirements. Responsibilities include maintaining the Quality Management System (QMS), supporting product release, managing quality investigations, document control, and regulatory submissions.

Key Responsibilities

  • Ensure compliance with cGMP, cGxP, and Health & Safety regulations.
  • Manage quality systems including deviations, CAPA, change control, complaints, and document control.
  • Support non-conformance investigations and finished product release.
  • Maintain SOPs, records, and quality documentation.
  • Prepare and manage regulatory submissions and product labelling (NDC, UPC, SPL).
  • Ensure product registrations are maintained with relevant regulatory authorities.
  • Review and approve product labelling and packaging documentation.
  • Monitor KPIs and support continuous improvement initiat...

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