Qc Analyst-API

Sarthee Consultancy; Ahmedabad District; On-site; INR 350,000 - 550,000; Full time

Job summary

Sarthee Consultancy in India is seeking a quality-focused analyst to perform analysis of raw materials, intermediates, and finished API products, operating instruments such as HPLC, GC, UV and IR to ensure product quality.

You will prepare reagents and calibration standards, maintain data integrity per ALCOA, and support method validation, stability studies, and audits within a cGMP/GLP-regulated environment.

Qualifications

• Experience in pharmaceutical analysis and quality control.
• Familiar with cGMP/GLP and data integrity concepts.
• Knowledge of method validation and stability studies is preferred.

Responsibilities

• Analyse 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 ALCOA data integrity principles.
• Handle OOS, OOT investigations and deviations.
• Testing & Analysis
• Support method validation, stability studies, and audits

Skills

Analytical skills

Detail-oriented

Problem solving

Education

B.Pharm/BSc in Chemistry

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