Job Purpose:To perform raw material, in-process, and finished product analysis using validated analytical techniques, ensuring compliance with GMP/GLP guidelines and regulatory requirements.Key Responsibilities:- Perform analysis of raw materials, in-process samples, and finished products as per approved specifications, test methods, and protocols. - Operate, calibrate, and maintain analytical instruments including HPLC, FTIR, and GC. - Troubleshoot analytical instruments, particularly HPLC systems, and ensure uninterrupted laboratory operations. - Ensure proper documentation and data integrity in compliance with GMP and GLP guidelines. - Maintain and update laboratory records, test reports, calibration records, logbooks, and analytical worksheets. - Utilize server-based chromatography software for data acquisition, processing, and reporting for HPLC and GC systems. - Ensure compliance with Good Documentation Practices (GDP) at all times. - Coordinate with QA for out-of-specification (OOS) investigations, deviations, and corrective actions when required. - Ensure proper handling, labeling, storage, and disposal of samples and chemicals. - Support internal and external audits by providing required documentation and technical explanations.Technical Skills & Knowledge:- Strong operating knowledge of HPLC, FTIR, and GC instruments. - Hands-on experience in calibration, operation, and troubleshooting of HPLC systems. - Knowledge of SAP for material management, data entry, or quality-related transactions. - Proficiency in MS Office applications (Word, Excel, PowerPoint). - Experience working with server-based chromatography software for HPLC and GC. - Understanding of GMP, GLP, GDP, and regulatory compliance requirements.Educational Qualification:- B.Sc / M.Sc in Chemistry / Analytical Chemistry / Pharmaceutical Sciences or equivalent.Experience:- 1–4 years of relevant experience in a QC laboratory within pharmaceutical / medical device / chemical manufacturing industries.
Job Title
Quality Control Associate