QMS OSD Packing

3 days ago

Ahmedabad, Gujarat, India Intas Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

Job Purpose

To ensure compliance of OSD packing operations with regulatory and company quality standards, by managing QMS activities such as deviations, change controls, CAPA, documentation, and audits.

Key Responsibilities

  • Ensure packaging operations are carried out as per cGMP, SOPs, and regulatory guidelines.

  • Handle QMS activities related to packaging, including:

  • Deviation management

  • Change control
  • CAPA implementation and follow-up

  • Document review and approval (SOPs, protocols, batch records)

  • Review and maintain packaging batch records and logbooks.

  • Coordinate with production, QA, and engineering teams for compliance requirements.
  • Assist in investigation of market complaints and implementation of corrective actions.
  • Support internal/external audits (regulatory and customer).
  • Monitor and ensure data integrity compliance in packaging documentation.
  • Training of packing personnel on QMS and GMP requirements.

Key Skills & Competencies

  • Good knowledge of cGMP, GDP, and regulatory requirements (USFDA, MHRA, EU, WHO).
  • Strong documentation and compliance skills.
  • Knowledge of packaging materials, processes, and equipment used in OSD manufacturing.
  • Analytical and problem-solving abilities.
  • Good communication and coordination skills.

Qualification & Experience

  • B. Pharm / M. Pharm / B.Sc. / M.Sc.
  • 26 years of experience in OSD Packaging & QMS activities.

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