Job Description

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