Role & responsibilities

- Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, and stability samples.

- Conduct testing of injectable products as per approved specifications, STPs, and pharmacopoeial requirements.

- Handle instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, pH Meter, Karl Fischer, Dissolution Apparatus, and analytical balances as applicable.

- Perform assay, related substances/impurities, identification, pH, water content, particulate matter, clarity, and other applicable tests for injectable products.

- Ensure proper sampling, testing, documentation, and timely release of analytical results.

- Prepare and maintain analytical worksheets, raw data, test reports, logbooks, and other QC records.

- Follow GLP, GMP, data integrity (ALCOA+) and laboratory safety requirements.

- Investigate and report Out of Specification (OOS), Out of Trend (OOT), and laboratory incidents/deviations as per procedures.

- Support method validation, method verification, method transfer, analytical method development, and instrument qualification activities.

- Perform calibration, verification, and routine maintenance of QC laboratory instruments as per SOPs.





- Maintain proper laboratory housekeeping and ensure availability of chemicals, reagents, standards, and consumables.

- Support stability study testing and maintain stability-related documentation.

- Coordinate with QA, Production, Microbiology, and other cross-functional departments for timely completion of testing and investigations.

- Participate in internal audits, regulatory inspections, and customer audits as required.

- Ensure compliance with current IP, BP, USP, Ph. Eur. and other applicable pharmacopoeial requirements.

- Follow all applicable company SOPs, safety procedures, and EHS requirements.

Preferred candidate profile

- Hands-on experience in pharmaceutical QC laboratory operations, preferably injectable manufacturing.

- Practical knowledge of HPLC and other analytical instruments.

- Knowledge of GMP, GLP, OOS/OOT, deviation, CAPA, change control, and data integrity.

- Good understanding of pharmacopoeial testing and analytical procedures.

- Positive documentation and communication skills.

- Ability to work independently as well as in a team.

- Willingness to work in shift operations, if required.

📌 Walk-in || Quality Control Analyst (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh