Quality Assurance Officer

Role & responsibilities

Job Title: Quality Assurance (QA) Officer

Department:

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

Company Details:

Meglus Pharmaceutical Pvt. Ltd.