The QC Officer will be responsible for performing routine and non-routine analysis of raw materials, intermediates, and finished APIs to ensure compliance with quality standards and regulatory requirements. The role involves analytical testing, documentation, instrument handling, and coordination with QA, production, and R&D teams.
Key Responsibilities:
• Perform chemical and instrumental analysis of raw materials, intermediates, and finished APIs as per approved specifications.
• Operate and maintain analytical instruments such as HPLC, GC, FTIR, UV, KF, and pH meter.
• Conduct stability studies, in-process, and release testing according to SOPs.
• Prepare and review analytical reports, COAs, and test data documentation.
• Ensure compliance with GMP, GLP, and data integrity principles in all laboratory operations.
• Participate in method validation, method transfer, and calibration activities.
• Maintain laboratory records, logbooks, and standardization reports.
• Handle OOS, OOT, deviation, and CAPA investigations as per quality procedures.
• Ensure proper housekeeping, safety, and instrument maintenance in the QC lab.
• Support internal, external, and regulatory audits.