Chemist (Quality Control) for Pharma Plant

Position Overview:

The QC Chemist is responsible for carrying out analytical testing of raw materials, intermediates, finished formulations, purified water, and stability samples in compliance with Indian regulatory guidelines, including WHO-GMP, cGMP, GLP, and Schedule M. The incumbent ensures that all testing activities meet quality standards required by CDSCO and applicable pharmacopoeias (IP/USP/BP/EP).

Key Responsibilities:1. Analytical Testing (As per Indian Pharma Standards)

• Perform analysis of raw materials, intermediates, and finished products as per Indian Pharmacopoeia (IP) and other approved methods.
• Test stability batches following ICH & CDSCO stability requirements.
• Conduct instrument-based analysis using HPLC, GC, UV-Vis spectrophotometer, FTIR, Dissolution Apparatus, pH meter, KF titrator, etc.
• Carry out Water Testing (Purified Water & WFI) as per IP limits and Schedule M requirements.
• Ensure timely sampling and testing in coordination with Production, QA, and Warehouse.

2. Documentation & Regulatory Compliance

• Maintain test records as per GDP (Good Documentation Practice) guidelines mandated by CDSCO.
• Prepare COA, test reports, logbooks, and maintain analytical raw data in compliance with Audit Trail requirements.
• Ensure all testing is in line with WHO-GMP & Schedule M guidelines applicable in India.
• Report OOS (Out of Specification), OOT (Out of Trend) results, and assist in root cause analysis & CAPA.
• Follow ALCOA+ principles for data integrity, as required in Indian pharma plants.

3. Laboratory Operations

• Ensure daily calibrations and proper operation of instruments as per respective SOPs.
• Maintain reference standards, working standards, volumetric solutions, and reagents as per Indian regulatory norms.
• Participate in Method Validation / Method Verification as per ICH Q2 guidelines.
• Adhere to lab safety, housekeeping, and proper waste disposal as per local pollution control guidelines.

4. Coordination & Cross-functional Support

• Coordinate with QA for batch release, document review, and deviations.
• Support Production in in-process testing and timely release of materials.
• Assist in external regulatory inspections (CDSCO, State FDA, WHO, Auditors, & Client Audits).
• Provide required analytical data during internal and external audits.

Skills & Competencies:

• Strong understanding of Indian Pharmaceutical Regulations & GMP norms.
• Good knowledge of IP analytical methods and general chemical testing.
• Knowledge of instrument handling, troubleshooting, and calibration.
• Strong attention to detail and accuracy.
• Good communication and teamwork skills.

Qualification & Experience:

• Education: B.Sc / M.Sc in Chemistry, Pharmaceutical Chemistry, or related field.
• Experience: 3–5 years in QC department of an Indian WHO-GMP certified pharmaceutical or nutraceutical manufacturing plant.

Job Types: Full-time, Permanent

Pay: ₹25,000.00 - ₹40,000.00 per month

Benefits:

• Paid sick time
• Paid time off
• Provident Fund

Work Location: In person