About this role
Quality Control Analyst will be responsible for performing analysis of raw materials, in-process samples, finished products, and stability samples in compliance with approved specifications, SOPs, and regulatory requirements (cGMP, USFDA, ICH). The role involves handling analytical instruments, ensuring data integrity, and maintaining documentation as per audit standards. Perform analysis of API, excipients, in-process, finished products, and stability samples. Execute testing using instruments such as HPLC, GC, UV-Visible Spectrophotometer, Dissolution, KF, IR, etc. Ensure adherence to approved STPs, specifications, and SOPs. Operate and maintain analytical instruments like HPLC, GC, Dissolution apparatus, FTIR, KF, etc. Perform routine checks, system suitability, and troubleshooting.
Required
Skills
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Strong knowledge of analytical techniques (HPLC, GC, etc.); Good understanding of cGMP, data integrity, and regulatory expectations; Familiarity with LIMS and electronic data management systems; Good documentation and communication skills; Must have experience in Empower and LIMS software.
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Qualifications: M.Sc (Chemistry), B.Pharm
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Additional Information: Record all raw data in notebooks and LIMS systems as per ALCOA+ principles. Ensure proper documentation with no overwriting, no loose sheets, and traceability. Review analytical data for accuracy and compliance. Follow cGMP, GLP, Data Integrity (DI), and regulatory guidelines. Assist in OOS, OOT, deviation, and incident investigations. Support root cause analysis and implementation of CAPA. Perform stability sample analysis and trending. Ensure timely completion of assigned samples.