Executive - ADL (API)

RPG Life Sciences; Kamareddy; On-site; INR 700,000 - 900,000; Full time

Job summary

RPG Life Sciences is seeking a focused analytical chemist to develop and validate methods for KSMs, intermediates and APIs at our site in India. The role involves operating HPLC/GC/UV-Vis/FTIR/KF instruments, calibrating key equipment, and preparing SOPs and regulatory-compliant reports.

The candidate will work under GMP/GLP regimes and apply ICH guidelines to development and validation activities, ensuring high quality data and compliant documentation.

Qualifications

• Experience in developing and validating analytical methods per ICH guidelines.
• Strong understanding of GMP/GLP regulatory expectations.
• Proficiency in preparing protocols, reports and SOPs.

Responsibilities

• Develop robust analytical methods for KSMs, intermediates and APIs.
• Validate analytical methods per regulatory requirements.
• Operate and maintain HPLC, GC, UV-Vis, FTIR, and Karl Fischer instruments.
• Calibrate critical instruments such as HPLC and GC.
• Prepare analytical protocols, reports, and SOPs.
• Ensure adherence to GMP, GLP and applicable regulatory standards.
• Apply ICH guidelines in method development and validation activities.

Skills

Analytical method development

Validation

Regulatory compliance

Documentation & SOP writing

Instrument calibration

Tools

HPLC

GC

UV-Vis

FTIR

Karl Fischer

Job description

• Develop robust analytical methods for Key Starting Materials (KSMs), intermediates, and Active Pharmaceutical Ingredients (APIs).
• Perform validation of analytical methods in compliance with regulatory requirements.
• Operate and maintain analytical instruments including HPLC, GC, UV-Vis, FTIR, and Karl Fischer (KF)
• Conduct calibration of critical instruments such as HPLC and GC
• Preparation of analytical protocols, reports, and Standard Operating Procedures (SOPs)
• Ensure strict adherence to GMP, GLP, and applicable regulatory standards
• Apply knowledge of ICH guidelines in method development and validation activities.