Quality Assurance

2 weeks ago

Pune, Maharashtra, India Inducare Pharma Private Limited Full time ₹ 36,00,000 - ₹ 42,00,000 per year

Designation - Quality Assurance (QA) In-Charge

Industry - Pharmaceutical

Experience:6–7 Years (QA Department – OSD Manufacturing: Tablets & Capsules)

Jejuri / Pune, Maharashtra

Qualification:

B.Pharm / M.Pharm / M.Sc. (Chemistry / Microbiology)

Key Responsibilities

1. Documentation and Record Control

  • Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
  • Control, issue, and retrieval of SOPs, formats, logbooks, and quality documents.
  • Maintain and update the Master Manufacturing Formula (MMF) and Standard Operating Procedures (SOPs).
  • Ensure data integrity and compliance with GDP (Good Documentation Practices).

2. In-Process Quality Assurance (IPQA)

  • Provide line clearance for all manufacturing and packing operations (dispensing, granulation, compression, coating, and packing).
  • Perform and monitor in-process checks (weight variation, hardness, thickness, disintegration, friability).
  • Ensure online documentation and traceability of all manufacturing activities.
  • Ensure environmental conditions and hygiene are maintained during production.

3. Deviations, Change Control & CAPA

  • Investigate and document deviations, OOS, OOT, and market complaints.
  • Execute and monitor Corrective and Preventive Actions (CAPA).
  • Review and manage Change Control requests in coordination with Production & QC.

4. Validation & Qualification

  • Participate in process validation, cleaning validation, and equipment qualification (IQ, OQ, PQ).
  • Review validation protocols and reports to ensure scientific and regulatory accuracy.

5. GMP Compliance & Audits

  • Conduct routine GMP inspections and ensure compliance in all departments.
  • Prepare and face regulatory, WHO, and customer audits.
  • Ensure timely closure of audit observations with effective CAPA implementation.

6. Training & Quality Culture

  • Conduct internal GMP, GDP, and hygiene training sessions.
  • Support quality improvement initiatives and maintain good documentation culture.

7. Batch Release

  • Review of QC analytical results and production records for final batch release.
  • Ensure that only approved materials and validated equipment are used.Skills & Competencies
  • In-depth knowledge of cGMP, WHO, GLP, GDP practices.
  • Experience with OSD (Tablet & Capsule) manufacturing processes.
  • Strong analytical, documentation, and communication skills.
  • Ability to lead and mentor QA executives/officers.
  • Audit handling and cross-functional coordination abilities.

Job Type: Full-time

Pay: ₹40, ₹70,000.00 per month

Benefits:

  • Health insurance
  • Provident Fund

Ability to commute/relocate:

  • Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Master's (Preferred)

Experience:

  • Pharmaceutical: 3 years (Required)
  • total work: 7 years (Preferred)
  • QA: 5 years (Required)

Work Location: In person

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