Qc Analyst-API

Sarthee Consultancy; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Sarthee Consultancy invites experienced professionals for analytical roles in pharmaceuticals based in Mumbai. The position involves rigorous testing of raw materials, intermediates, and finished API products using instruments such as HPLC, GC, UV, and IR.

The candidate will prepare reagents, maintain calibration standards, and uphold data integrity per ALCOA while addressing OOS/OOT investigations and deviations as needed.

Qualifications

• Strong knowledge of analytical instrumentation and laboratory practices.
• Familiarity with data integrity concepts (ALCOA) and GLP guidelines.
• Experience handling OOS/OOT investigations is a plus.

Responsibilities

• Analyze raw materials, intermediates, and finished API products.
• Operate analytical instruments like HPLC, GC, UV, and IR.
• Prepare reagents, solutions, and calibration standards.
• Ensure compliance with cGMP and regulatory guidelines and maintain data integrity.

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