Quality Assurance Officer

6 hours ago

Ahmedabad, Gujarat, India Kashmik Formulation Private Limited Full time ₹ 46,02,638 - ₹ 55,23,166 per year

Job description:

We are looking for a dedicated and detail-oriented Quality Assurance Officer to join our pharmaceutical team. The ideal candidate should have sound knowledge of cGMP, documentation practices, and regulatory compliance (ICH, WHO, USFDA, etc.). The role involves reviewing manufacturing and analytical records, ensuring compliance, and supporting internal and external audits.

Key Responsibilities:

  • Ensure adherence to cGMP, GLP, and data integrity principles in all QA-related activities.
  • Manage document control — issuance, review, retrieval, and archiving of controlled documents (SOPs, protocols, logbooks, etc.).
  • Participate in internal audits, self-inspections, and regulatory audits.
  • Handle deviations, change controls, CAPA, and incident investigations.
  • Coordinate with production, QC, and warehouse teams to ensure compliance with company and regulatory standards.
  • Monitor and review calibration and qualification records of equipment and instruments.
  • Support vendor qualification, training programs, and quality risk management activities.
  • Maintain records for product quality reviews (PQRs) and validation documentation.
  • Assist in ensuring audit readiness and continuous improvement of the quality management system (QMS).

Candidate Requirements:

  • B.Pharm / M.Pharm / B.Sc. / M.Sc. in Pharmaceutical Sciences, Chemistry, or related field.
  • 0-2 years of experience in QA activities within a pharmaceutical manufacturing plant.
  • Strong understanding of cGMP, ICH, WHO, and regulatory guidelines.
  • Experience in documentation, deviation management, and QMS modules.
  • Good communication, analytical, and organizational skills.
  • Proficiency in MS Office and knowledge of electronic documentation systems (if applicable).

Job Type:

  • Full-time, Permanent

Benefits:

  • Provident Fund
  • Professional growth opportunities

Job Types: Full-time, Permanent

Pay: ₹10, ₹46,026.38 per month

Work Location: In person

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