Job Description

Perform analysis of raw materials, intermediates, APIs, solvents, and finished products as per approved specifications and analytical methods. Carry out testing using HPLC, GC, UV-Visible Spectrophotometer, Karl Fischer, pH meter, and other QC instruments. Perform analytical tests including assay, related substances/impurities, residual solvents, water content, identification, purity, and other applicable tests. Execute analysis according to approved STPs, SOPs, pharmacopoeial methods, and validated analytical procedures. Prepare samples, standards, reagents, mobile phases, buffers, and other laboratory solutions as required. Perform system suitability and ensure instruments are suitable before analysis. Review chromatograms, calculations, analytical results, and raw data for accuracy. Maintain proper documentation in analytical worksheets, instrument logbooks, usage records, and laboratory registers. Prepare analytical reports and Certificates of Analysis (COA) as applicable. Ensure proper labeling, storage, and traceability of samples, standards, reagents, and solutions. Follow GMP, GLP, SOP, safety, and data-integrity (ALCOA+) requirements. Report abnormal results, OOS/OOT results, and laboratory incidents to the appropriate supervisor. Support OOS/OOT investigations, deviations, CAPA, change controls, and laboratory investigations. Perform routine instrument calibration, verification, and maintenance activities as per approved procedures. Coordinate with external service engineers for instrument troubleshooting and preventive maintenance. Support analytical method validation, method verification, method transfer, and stability studies. Coordinate with Production, QA, Warehouse, and other departments for timely completion of QC activities.


Job Details

Role Level: Mid-Level Work Type: Full-Time
Country: India City: Dahej ,Gujarat
Company Website: http://www.cplltd.com Job Function: General Management
Company Industry/
Sector:
Pharmaceutical Manufacturing

What We Offer


About the Company

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