Senior Executive

Contract Pharmaceuticals Limited; Dahej; On-site; INR 350,000 - 550,000; Full time

Job summary

Contract Pharmaceuticals Limited in Dahej, Gujarat, seeks a meticulous QC Analyst to perform analysis on raw materials, intermediates, APIs, solvents, and finished products. You will conduct tests with HPLC, GC, UV-Visible, Karl Fischer, and pH meters, following approved procedures and ensuring data integrity.

You will prepare samples and reagents, review results, generate COAs, and maintain thorough documentation while adhering to GMP/GLP and ALCOA+ standards, reporting any OOS/OOT issues and

Qualifications

• Analyze raw materials, intermediates, APIs, solvents, and finished products per approved specifications.
• Carry out analytical testing and ensure accuracy and compliance with procedures.
• Prepare samples, standards, reagents, and buffers as required.
• Ensure instrument readiness and document results.

Responsibilities

• Analyze raw materials, intermediates, APIs, solvents, and finished products.
• Perform tests using HPLC, GC, UV-Vis, Karl Fischer, pH meter and other QC instruments.
• Prepare samples, standards, reagents, mobile phases, buffers, and other laboratory solutions.
• Review chromatograms, calculations, results, and raw data for accuracy.
• Maintain documentation in worksheets, instrument logbooks, usage records, and laboratory registers.
• Prepare analytical reports and COAs as applicable.
• Ensure labeling, storage, and traceability of samples and reagents.
• Follow GMP, GLP, SOP, safety and ALCOA+ data integrity requirements.
• Report abnormal results, OOS/OOT results, and laboratory incidents.
• Support investigations and CAPA, change controls, and lab investigations.
• Coordinate with external service engineers for instrument maintenance.
• Support method validation, verification, transfer, and stability studies.
• Coordinate with Production, QA, Warehouse, and other departments for timely QC completion.

Skills

Analytical testing

Data integrity

Documentation

GMP/GLP compliance

Laboratory troubleshooting

Tools

HPLC

GC

UV-Vis spectrophotometer

Karl Fischer

pH meter

Job description

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.

Requirements