QC Senior Chemical Analyst

Role Summary

To perform routine and non‑routine chemical analysis of raw materials, packaging materials, in‑process samples, finished products, stability samples, and reference standards in accordance with approved specifications, pharmacopeial requirements, cGMP, GLP, and regulatory guidelines. The role ensures timely and accurate analytical support while maintaining data integrity, laboratory compliance, and continuous improvement of Quality Control operations.

• Perform chemical analysis of raw materials, in‑process materials, finished products, stability samples, and cleaning validation samples according to approved specifications and analytical methods.
• Execute analytical testing while ensuring compliance with cGMP, GLP, ALCOA+, Data Integrity, and Good Documentation Practices (GDP).
• Operate, calibrate, maintain, verify, and troubleshoot laboratory instruments including HPLC, GC, UV‑Visible Spectrophotometer, FTIR, Dissolution Tester, Karl Fischer, pH Meter, and Analytical Balance.
• Prepare reagents, volumetric solutions, mobile phases, reference standards, and analytical solutions accurately.
• Perform analytical method validation, method verification, method transfer, and analytical troubleshooting.
• Review analytical data, chromatograms, calculations, and laboratory documentation before final submission.
• Participate in investigations related to OOS, OOT, Deviations, Laboratory Incidents, Change Control, and CAPA implementation.
• Maintain laboratory documentation, equipment logbooks, worksheets, and analytical records in accordance with GMP requirements.
• Ensure laboratory equipment remains qualified, calibrated, and fit for use.
• Maintain inventory and qualification status of laboratory chemicals, reagents, solvents, consumables, and reference standards.
• Support Regulatory Affairs, Quality Assurance, Production, Supply Chain, and regulatory authority requirements by providing analytical and technical support.
• Participate in internal audits, regulatory inspections, customer audits, and self‑inspections.
• Follow laboratory safety procedures, environmental health and safety requirements, and proper use of PPE.
• Support continuous improvement initiatives within the Quality Control laboratory.
• Perform any additional Quality Control duties assigned by the supervisor.

• Bachelor's degree in chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline (master's degree is preferred).
• 4–6 years of Quality Control experience in a regulated pharmaceutical manufacturing environment.
• Strong knowledge of cGMP, GLP, Data Integrity, ALCOA+, and pharmaceutical Quality Control systems.
• Good understanding of USP, BP, EP, IP, ICH Guidelines, WHO, SFDA, USFDA, MHRA, and EMA regulations.
• Experience with HPLC, GC, FTIR, UV‑Visible Spectrophotometer, Dissolution Tester, Karl Fischer, and other analytical laboratory instruments.
• Knowledge of Stability Studies, analytical method validation, instrument calibration, and laboratory investigations.
• Familiarity with LIMS, Empower (or equivalent), and Microsoft Office applications.