Job Summary

The QC Analyst is responsible for conducting laboratory analysis of raw materials, finished products, stability, and validation samples in compliance with cGMP, GDocP, and data integrity requirements. The role involves sample handling, preparation of test solutions, operation and calibration of laboratory equipment, documentation of analytical results, and maintenance of quality records to ensure products meet the required quality standards.

• Conduct analysis of raw materials, finished products, stability, and validation procedures and quality standards.
• Receive, handle, and store laboratory samples while ensuring sample integrity throughout the analysis process.
• Prepare and maintain test solutions, reagents, and volumetric solutions.
• Operate, calibrate, and perform routine maintenance of QC laboratory instruments and equipment.
• Prepare accurate analytical reports and maintain all laboratory records, registers, and documentation.
• Support preparation and review of raw material, finished product, and stability specifications.
• Update analysis status in manual and electronic data management systems.
• Report deviations, unusual observations, or laboratory incidents promptly.
• Ensure compliance with cGMP, GDocP, ALCOA principles, and company data integrity requirements.

• Exceptional attention to detail in documentation.
• Good organizational and time management skills.
• Ability to work well under pressure and without supervision in a fast-paced work environment.
• Good knowledge on effective quality documentation systems.
• Computer Literacy i.e. Ms. Word, Excel, PowerPoint, Access etc.

• Minimum Degree in Chemistry, Pharmacy, Lab technology, Microbiology or a related field.
• At least three (3) years of experience in a laboratory in pharmaceutical manufacturing.
• Strong knowledge of regulatory requirements pertaining to GMP and GLPs.
• Knowledge and exposure to various analytical QC methods and equipment.