Senior Chemist (Method Validation)

Role & responsibilities

• Perform analytical method validation as per ICH guidelines and regulatory requirements.
• Execute method verification, method transfer, and analytical troubleshooting activities.
• Prepare and review method validation protocols and reports.
• Perform data interpretation and statistical evaluation of analytical results.
• Perform analytical method validation by evaluating parameters such as specificity, linearity, accuracy, precision, robustness, ruggedness, LOD, LOQ, and range in accordance
• Ensure compliance with GLP, Data Integrity, and laboratory safety requirements.
• Maintain analytical records, laboratory notebooks, raw data, and instrument logbooks.
• Support regulatory submissions by providing analytical validation documents.
• Investigate Out of Specification (OOS), Out of Trend (OOT), and laboratory incidents.

Preferred candidate profile

2-5 years of experience in Analytical R&D/Method Validation.

Hands-on experience with HPLC, GC, and related analytical instruments.

Knowledge of ICH guidelines.

Familiarity with Empower, Chromeleon, or similar chromatography software.