Quality Assurance Officer

4 days ago

Ahmedabad, Gujarat, India Meglus pharmacutical PVT LTD Full time

Role & responsibilities

Job Title: Quality Assurance (QA) Officer

Department: Quality Assurance

Location: Piplaj, Ahmedabad

Job Responsibilities:

1. Quality Compliance & Documentation:

  • Ensure compliance with cGMP, GLP, and company SOPs across all departments.
  • Review and control of Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
  • Ensure proper documentation and archival of all QA records as per GDP (Good Documentation Practices).
  • Review and preparation of Annual Product Quality Reports (APQRs).
  • Review and maintain calibration and validation documentation for all instruments and equipment.
  • Review and maintain records for documentation issuance, retrieval, and control.

2. Process Monitoring & Audits:

  • Conduct in-process checks and line clearances during manufacturing and packaging.
  • Participate in internal audits and assist during regulatory inspections (WHO, GMP, etc.).
  • Perform internal audits and submit reports to facility management.
  • Assist in audit preparation (regulatory, third-party, and customer audits).
  • Monitor deviations, change controls, CAPA, and OOS/OOT investigations.

3. Validation & Qualification:

  • Review, preparation, and participation in qualification and validation activities.
  • Verify temperature mapping activities for equipment, instruments, and areas.
  • Monitor and compile data related to equipment/instrument qualification and validation.

4. SOP & Training Management:

  • Assist in the preparation, review, and revision of SOPs, specifications,and validation protocols.
  • Prepare and review all SOPs for the facility as per regulatory requirements.
  • Maintain and update training records for all employees.
  • Support and conduct training programs related to GMP compliance and quality systems.

5. Coordination & Vendor Management:

  • Coordinate with Production, QC, and Warehouse teams to ensure consistent product quality.
  • Participate in vendor qualification activities as per company SOPs.
  • Support management in continuous improvement initiatives and compliance projects.

Required Qualifications:

  • Education: B.pharm ,B.Sc. / M.Sc.
  • Experience: 1 to 2 years in a Quality Assurance role

Skill Set:

  • Strong knowledge of cGMP, GLP, and GDP practices.
  • Excellent documentation and analytical skills.
  • Good coordination and communication abilities.
  • Strong attention to detail and compliance mindset.

Work Hours:

9:30 AM to 6:00 PM

Monday to Saturday

Company Details:

Meglus Pharmaceutical Pvt. Ltd.

Piplaj, Ahmedabad, Gujarat

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