Qc Analyst-API

Sarthee Consultancy; Bengaluru; On-site; INR 500,000 - 1,000,000; Full time

Job summary

Sarthee Consultancy in Bengaluru, India, invites applications for an analytical chemist to perform analysis of raw materials, intermediates, and finished API products. You will operate HPLC, GC, UV, and IR, while preparing reagents and calibration standards.

Maintain data integrity (ALCOA), handle OOS/OOT investigations and deviations, and support method validation, stability studies, and audits in a cGMP/GLP-regulated environment.

Qualifications

• Experience in analytical testing of materials and APIs.
• Familiarity with cGMP and GLP regulatory requirements.
• Ability to maintain data integrity according to ALCOA principles.

Responsibilities

• Perform analysis of raw materials, intermediates, and finished API products
• Operate instruments like HPLC, GC, UV, and IR
• Prepare reagents, solutions, and calibration standards
• Ensure compliance with cGMP, GLP, and regulatory guidelines
• Maintain proper documentation as per data integrity (ALCOA) principles
• Handle OOS, OOT investigations and deviations
• Testing & Analysis
• Support method validation, stability studies, and audits

Skills

HPLC

GC

UV

IR

cGMP

GLP

Job description

Role & responsibilities:

• Perform analysis of raw materials, intermediates, and finished API products
• Operate instruments like HPLC, GC, UV, and IR
• Prepare reagents, solutions, and calibration standards
• Ensure compliance with cGMP, GLP, and regulatory guidelines
• Maintain proper documentation as per data integrity (ALCOA) principles
• Handle OOS, OOT investigations and deviations
• Testing & Analysis
• Support method validation, stability studies, and audits