5 - 10 years

3 - 7 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

1. Quality Management System (QMS) Activities

  • Implement and maintain site QMS in line with cGMP, WHO, and regulatory guidelines.
  • Ensure compliance of Liquid Orals manufacturing with quality standards.

2. Documentation & SOP Control

  • Prepare, review, and update SOPs, BMRs, BPRs, formats, and QMS documents.
  • Control issuance and archival of documents as per procedure.

3. Change Control

  • Initiate, review, and close Change Control requests related to processes, equipment, and documents.
  • Evaluate impact and ensure timely implementation.

4. Deviation & CAPA Management

  • Review deviations, investigations, and root-cause analysis.
  • Track and monitor CAPA implementation and effectiveness.

5. OOS / OOT Handling

  • Assist in investigation of Out of Specification / Out of Trend results.
  • Ensure proper documentation and closure.

6. Internal & External Audits

  • Participate in internal audits, self-inspections, and GMP audits.
  • Prepare documents for regulatory, customer, and third-party audits

Preferred candidate profile

Role Summary

The Executive QMS will be responsible for implementing, monitoring, and maintaining Quality Management Systems for Liquid Oral formulations as per GMP, regulatory guidelines, and company standards. The role ensures compliance, documentation control, and continuous quality improvement.

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