Qc Analyst-API

Sarthee Consultancy; Pune District; On-site; INR 350,000 - 650,000; Full time

Job summary

Sarthee Consultancy in Pune seeks a detail-oriented analyst to perform analyses on raw materials, intermediates, and finished API products using HPLC, GC, UV, and IR.

Responsibilities include preparing reagents and calibration standards, maintaining ALCOA data integrity, handling OOS/OOT investigations, and supporting method validation, stability studies, and audits, while ensuring regulatory compliance.

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

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