Chemist – Quality Assurance (QA) for Pharma Plant

Position Overview:

The QA Chemist is responsible for ensuring that all manufacturing activities, documentation, and quality processes comply with Indian regulatory requirements (Schedule M, CDSCO, WHO-GMP, cGMP). The role involves reviewing batch records, managing deviations, overseeing in-process controls, and ensuring data integrity and compliance throughout the manufacturing operations.

Key Responsibilities:1. Batch Documentation & Quality Compliance

• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with SOPs.
• Ensure all documents follow GDP (Good Documentation Practices) and ALCOA+ principles.
• Coordinate for batch release by verifying QC results, in-process checks, and production compliance.

2. In-Process Quality Assurance (IPQA)

• Carry out line clearance for dispensing, manufacturing, filling, and packaging operations.
• Conduct in-process checks such as weight variation, hardness, disintegration, leak test, pH, labeling checks, etc.
• Monitor adherence to approved procedures and ensure compliance with cGMP & Schedule M guidelines.

3. Quality Systems Management

• Handle and update Change Controls, Deviations, CAPA, Incidents, and Market Complaints.
• Maintain and revise SOPs, BMRs, and BPRs as per regulatory and operational requirements.
• Participate in internal audits and support external audits (State FDA, CDSCO, WHO, client audits).
• Ensure proper document archival and control through Document Control Systems.

4. Validation & Qualification Activities

• Assist in process validation, cleaning validation, equipment qualification, and hold-time studies.
• Review protocols and reports prepared as per WHO-GMP & ICH guidelines.

5. Training & Compliance Monitoring

• Conduct and document GMP, hygiene, and documentation training for production and support staff.
• Monitor shop floor practices to ensure adherence to hygiene, safety, and regulatory standards.
• Support investigation of OOS/OOT, deviations, and ensure timely implementation of CAPA.

6. Coordination & Cross-Functional Support

• Liaise with Production, QC, Warehouse, and Engineering for smooth quality operations.
• Ensure proper sampling of RM/PM and timely coordination with QC for testing.
• Verify dispensing activities and ensure correct material status labeling across the plant.

Skills & Competencies Required:

• Strong understanding of GMP, WHO-GMP, and Schedule M requirements.
• Good knowledge of QA processes, documentation, and pharmaceutical manufacturing operations.
• Excellent attention to detail and compliance-oriented mindset.
• Strong communication skills and ability to enforce quality standards on the shop floor.
• Ability to handle audits and regulatory inspections.

Qualification & Experience:

• Education: B.Sc / M.Sc in Chemistry, Pharmaceutical Chemistry, Microbiology, or related field.
• Experience: 1–5 years in QA department of a WHO-GMP certified pharmaceutical or nutraceutical plant.
• Freshers with good academic knowledge may also be considered.

Job Types: Full-time, Permanent

Pay: ₹18,000.00 - ₹30,000.00 per month

Benefits:

• Paid sick time
• Paid time off
• Provident Fund

Work Location: In person