Senior Executive-Quality Control (RM Section Head)

raw materials (API & excipients)

sampled, tested, and released

Key Responsibilities

• Sampling & Receipt:
• Receive and verify raw material intimation from warehouse.
• Ensure GMP-compliant sampling using appropriate tools and under classified environments (if applicable).
• Label samples properly and maintain sampling logbooks.
• Ensure composite and individual sampling as per SOPs.
• Testing & Analysis:
• Perform physicochemical testing of APIs and excipients as per:
• IP, BP, USP, Ph. Eur., or in-house specifications
• Conduct tests like:
• Identification (FTIR/UV/chemical tests)
• Assay, pH, Loss on drying, Sulphated ash, Heavy metals, etc.
• Follow material specifications and STPs/SOPs for each product.
• Cross-check vendor COAs and investigate discrepancies.
• Documentation & Release:
• Record results in analytical reports / raw data sheets.
• Prepare Certificate of Analysis (COA) for approved raw materials.
• Ensure all logbooks, registers, and worksheets are properly filled and signed.
• Coordinate with QA for material release tagging
• Compliance & Audit Readiness:
• Adhere to cGMP, GLP, and Schedule M requirements.
• Follow data integrity practices (ALCOA+).
• Support in OOS/OOT investigations and ensure timely CAPA closure.
• Assist during regulatory audits (USFDA, MHRA, WHO-GMP) and internal quality audits
  



• Instrument Handling:
• FTIR / UV-Vis Spectrophotometer
• Karl Fischer Apparatus (moisture content)
• pH meter / Melting point apparatus
• Analytical balance, Water bath, etc.
• Ensure proper calibration and maintenance of instruments used
  

Education :