Quality Chemist

Job Description QC Chemist

Department: Quality Control (QC)

Location: Alandi, Pune Industry: API / Pharmaceutical Manufacturing Experience: 1–3 Years Preferred

Employment Type: Full-time

Job Overview-

We are looking for a QC Chemist to perform sampling, testing, documentation, and laboratory activities in compliance with cGMP, GLP, and Good Documentation Practices (GDP). The candidate will be responsible for ensuring the quality and reliability of raw materials, in-process materials, finished products, water, and other samples.

Key Responsibilities-

Perform sampling of raw materials, packaging materials, water, in-process samples, validation samples, stability samples, finished products, process aids, and equipment cleaning samples.

Carry out analysis of various samples using approved analytical methods and techniques for which the employee is qualified.

Operate, maintain, and perform routine calibration checks of QC laboratory instruments and equipment.

Maintain proper inventory and upkeep of laboratory chemicals, analytical standards, glassware, reagents, indicators, and volumetric solutions.

Prepare, standardize, label, and maintain reagents, indicators, and volumetric solutions as per approved procedures.

Monitor and maintain records for reserve/control sample rooms and stability chambers.

Monitor temperature and humidity of laboratory working areas and maintain relevant records.

Ensure compliance with GLP, GDP, cGMP, SOPs, safety procedures, and company policies.

Maintain and control QC documentation, including analytical worksheets, logbooks, test reports, and other laboratory records.

Ensure analytical data is recorded accurately, completely, and contemporaneously in accordance with data integrity requirements.

Promptly report discrepancies, incidents, OOS, OOT, deviations, and non-conformities to the QC Supervisor/Manager.

Follow all prescribed laboratory safety precautions while handling chemicals, samples, instruments, and laboratory equipment.

Maintain proper housekeeping and cleanliness of the QC laboratory.

Coordinate with QA, Production, R&D, and other relevant departments whenever required.

Participate in method validation, analytical method verification, cleaning validation, and stability studies as assigned.

Support internal and external audits/inspections by maintaining accurate and readily retrievable QC records.

Required Skills-

Good knowledge of cGMP, GLP, GDP, SOPs, OOS/OOT, and data integrity.

Hands-on knowledge of QC laboratory testing and analytical procedures.

Familiarity with laboratory instruments and equipment.

Strong documentation and record-keeping skills.

Attention to detail and commitment to quality.

Good communication and teamwork skills.

Ability to follow safety procedures and laboratory practices.

Preferred Experience-

1–3 years of experience in Quality Control, preferably in an API/Pharmaceutical manufacturing company.

Exposure to raw material, in-process, finished product, water, stability, and cleaning sample analysis.

Knowledge of laboratory instruments, analytical methods, OOS/OOT investigations, and GMP documentation will be an added advantage.