Job Summary The Quality Control Officer will be responsible for performing routine and stability analysis of Active Pharmaceutical Ingredients (APIs) using analytical instruments such as HPLC and GC while ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and regulatory requirements. The role requires hands-on analytical expertise, documentation skills, and adherence to quality standards. Key Responsibilities Perform routine, in-process, raw material, finished product, stability, and cleaning validation sample analysis using HPLC and GC. Execute analytical testing as per approved specifications, test methods, SOPs, and pharmacopoeial requirements. Prepare and standardize reagents, volumetric solutions, and reference standards. Review analytical data, chromatograms, calculations, and test results for accuracy and compliance. Maintain laboratory documentation, including analytical worksheets, logbooks, instrument usage records, and electronic data in accordance with ALCOA+ principles. Perform routine calibration, verification, and basic troubleshooting of HPLC, GC, and other laboratory instruments. Support method verification, method transfer, and analytical method validation activities as required. Ensure compliance with cGMP, GLP, data integrity, and regulatory requirements. Participate in laboratory investigations, OOS (Out of Specification), OOT (Out of Trend), deviations, CAPA, and change control activities. Maintain laboratory housekeeping and ensure safe handling of chemicals and laboratory equipment. Assist during internal, customer, and regulatory audits. Qualifications Master's degree in Chemistry, Analytical Chemistry. Experience 2–5 years of Quality Control experience in the pharmaceutical industry. Hands-on experience with HPLC and GC analysis is mandatory. Experience in API manufacturing or API Quality Control is preferred. Experience working in a GMP and GLP environment is mandatory. Required Skills Strong practical knowledge of HPLC and GC operation, troubleshooting, and data interpretation. Good understanding of analytical techniques and laboratory documentation practices. Knowledge of cGMP, GLP, ICH guidelines, pharmacopoeial requirements, and data integrity principles. Familiarity with OOS, OOT, deviations, CAPA, and change control processes. Good communication, documentation, and teamwork skills. Proficiency in MS Office and laboratory software such as Empower, Chromeleon, or similar chromatography data systems is an added advantage.
