Assistant Manager

About the role

To perform and review quality control analysis of API, intermediates, raw materials, in-process samples, finished products and stability samples in compliance with approved specifications, SOPs, GMP and data-integrity requirements. To ensure reliable and safe operation of mechanical equipment and utility systems in the API manufacturing plant through preventive, predictive and breakdown maintenance while maintaining GMP, safety and regulatory compliance.

What you'll do

• Perform analysis of API, intermediates, raw materials, in-process and finished products as per approved specifications and SOPs
• Handle and troubleshoot HPLC and GC instruments for routine and stability analysis
• Perform analytical testing such as assay, related substances/impurities, residual solvents, water content, identification and purity
• Operate and maintain laboratory instruments including HPLC, GC, UV, IR, Karl Fischer, pH meter, etc
• Prepare mobile phases, diluents, standards and reagents accurately

What you need

• 8–12 yrs of experience
• Production planning
• Quality control
• Preventive maintenance
• Mechanical engineering
• Root cause analysis
• PLC
• B.Sc or M.Sc or B.Pharm or M.Pharm or B.Tech or B.E. or Diploma

Good to have

• HPLC
• GMP
• GLP
• Safety management
• Chemistry
• Instrumentation