Key Responsibilities:

• Review and approve analytical documents such as STPs, specifications, and reports.
• Ensure compliance of QC laboratory activities with GMP, GLP, and data integrity principles.
• Review analytical data, test results, and certificates of analysis (COA).
• Handle OOS, OOT, deviations, and CAPA related to QC/analytical activities.
• Audit laboratory records, logbooks, and instrument usage.
• Ensure calibration and qualification status of analytical instruments.
• Support method validation, transfer, and verification activities.
• Participate in internal audits and regulatory inspections (USFDA, WHO, EU GMP).
• Ensure proper documentation and control of records as per GDP practices.
• Coordinate with QC, Production, and other departments for quality compliance.