Key Responsibilities
1. QA Documentation & Document Control
- Preparation, review, approval, issuance, and control of QA documents including SOPs, STPs, BMRs, BPRs, formats, manuals, and policies.
- Management of Document Control System, including master lists, revision control, issuance, retrieval, and archival of documents.
- Ensuring availability of current and approved documents at points of use.
2. Good Documentation Practices (GDP)
- Implementation, monitoring, and training of Good Documentation Practices (GDP) across departments.
- Periodic review of records to ensure compliance with GDP requirements.
3. Change Control
- Handling Document Change Control (DCC) and ensuring timely evaluation, approval, implementation, and closure.
- Impact assessment of document changes on quality systems and regulatory compliance.
4. Record Review & Compliance
- Review of Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), logbooks, and quality records.
- Identification, documentation, and follow-up of discrepancies in records.
5. Deviations, CAPA & Risk Management
- Documentation and review of Deviations, CAPA, Change Controls, and Risk Assessments.
- Monitoring CAPA effectiveness and ensuring timely closure.
6. Audits & Regulatory Compliance
- Support internal, external, customer, and regulatory audits.
- Preparation and retrieval of documents during audits.
- Ensuring compliance with GMP / WHO-GMP / ISO standards and applicable regulatory guidelines.
7. Training & Coordination
- Conducting and coordinating training on QA documentation, GDP, and SOP compliance.
- Coordination with Production, QC, Warehouse, Engineering, and Regulatory teams.
Qualifications & Experience
- Education: B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent.
- Experience: 6–10 years in QA Documentation / QA Systems in pharmaceutical or regulated industries.
- Strong knowledge of GMP, WHO-GMP, ISO, and documentation practices.
Skills & Competencies
- In-depth knowledge of QA documentation systems
- Strong understanding of regulatory compliance
- Attention to detail and data integrity focus
- Excellent coordination and communication skills
- Proficiency in MS Office and documentation systems
Job Types: Full-time, Permanent
Pay: ₹300,000.00 - ₹600,000.00 per year
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
