Job Description

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