Qc Analyst-API

Sarthee Consultancy; Valsad District; On-site; INR 500,000 - 800,000; Full time

Job summary

Sarthee Consultancy in Gujarat is seeking a laboratory analyst to perform material and product analysis and operate analytical instruments. The role includes preparing reagents and calibration standards, with a strong focus on regulatory compliance and data integrity.

The position involves adherence to cGMP/GLP guidelines, involvement in method validation, stability studies, and audits to ensure quality and compliance in API testing and analysis.

Responsibilities

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

Tools

HPLC

GC

UV

IR

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