Senior Executive/Junior Manager

http://nauk.in/bpfLwvP

Key Responsibilities:

• Perform analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs) as per approved specifications and SOPs.
• Operate and maintain analytical instruments like HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, etc.
• Review and verify analytical data and ensure proper documentation in line with cGMP and GLP guidelines.
• Prepare and standardize volumetric solutions and reagents.
• Carry out stability studies and maintain stability data as per ICH guidelines.
• Ensure timely calibration of laboratory instruments.
• Perform method validation/transfer activities as per regulatory and internal requirements.
• Involve in investigations related to OOS/OOT/Deviations and CAPA implementation.
• Coordinate with cross-functional departments like QA, Production, and R&D for smooth workflow.
• Comply with all safety protocols and maintain a clean and organized lab environment.

Desired Candidate Profile:

• Hands-on experience in analytical techniques (HPLC/GC) is a must.
• Good knowledge of regulatory guidelines (ICH, WHO, USFDA, etc.)
• Strong documentation and communication skills.
• Experience in a regulated API manufacturing unit is preferred.

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