Job Purpose
To lead the Quality Control function at an API manufacturing facility, ensuring timely testing and release of raw materials, intermediates, in-process samples, finished APIs and stability samples in compliance with cGMP, applicable pharmacopoeial standards and regulatory requirements.
The role is responsible for laboratory operations, analytical method management, data integrity, investigations, instrument qualification, team development and continuous improvement of QC systems.
2. Key Responsibilities
A. QC Laboratory Operations
• Lead day-to-day operations of the Quality Control laboratory for API and intermediate manufacturing.
• Ensure timely analysis of raw materials, intermediates, in-process samples, finished products and stability samples.
• Review and approve analytical results, laboratory records and certificates of analysis (CoAs), as authorized.
• Ensure testing is performed according to approved specifications, analytical methods, SOPs and applicable pharmacopoeial requirements.
• Coordinate with Production, QA, R&D;,



Warehouse and Regulatory Affairs to support manufacturing and product release timelines.
• Monitor sample receipt, testing turnaround time, pending analysis and laboratory workload.
• Ensure proper handling, storage, retention and disposal of laboratory samples.

B. Analytical Testing & Instrumentation
• Ensure effective utilization and maintenance of analytical instruments, including:
• HPLC and GC
• UV-Visible spectrophotometer
• FTIR
• Karl Fischer titrator
• pH meter and conductivity meter
• Dissolution or other applicable analytical systems, where relevant
• Wet chemistry and titration equipment
• Oversee testing for assay, related substances, impurities, residual solvents, water content and other relevant API quality attributes.
• Ensure instrument calibration, qualification, preventive maintenance and timely servicing.
• Review chromatograms, calculations, analytical worksheets and instrument-generated data.
• Ensure prop

📌 AGM:- QC (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar