Executive - ADL (API)

Actis Generics Pvt. Ltd; Visakhapatnam; On-site; INR 600,000 - 850,000; Full time

Job summary

Actis Generics Pvt. Ltd. is seeking a qualified analytical chemist to develop robust methods for KSMs, intermediates, and APIs. The role includes validation, protocol and SOP preparation, and maintenance of instruments such as HPLC, GC, UV-Vis, FTIR, and KF.

You will ensure GMP/GLP compliance and apply ICH guidelines to method development and validation activities, contributing to regulatory readiness and product quality.

Responsibilities

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

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.