METHOD VALIDATION ANALYST ( HPLC/GC

Job Description:

Key Responsibilities

Method Validation & Development

• Perform method validation as per ICH Q2 (R1/R2) guidelines

• Develop, optimize, and validate analytical methods for assay, impurities, dissolution, and residual solvents

• Conduct method verification and method transfer activities

• Prepare and review validation protocols and reports

Instrumentation & Analysis

• Operate and maintain HPLC, UPLC, GC, and related detectors (UV, PDA, FID, HS-GC)

• Perform routine analysis of API, finished products, stability samples, and raw materials

• Troubleshoot analytical and instrument-related issues

Documentation & Compliance

• Prepare and review SOPs, STPs, analytical worksheets, and reports

• Ensure compliance with GMP, GLP, data integrity, and regulatory requirements

• Participate in internal audits, regulatory inspections, and investigations (OOS/OOT)

Laboratory Practices

• Ensure proper calibration and qualification of analytical instruments

• Maintain laboratory cleanliness, safety, and compliance

• Train junior analysts as required

Required Skills & Competencies

• Strong hands-on experience with HPLC and GC

• Good knowledge of ICH, USP, EP, FDA, and EMA guidelines

• Experience in method validation, troubleshooting, and data interpretation

• Knowledge of data integrity (ALCOA principles)

• Proficient in documentation and report writing

Preferred Skills

• Experience with software such as Empower, ChemStation, or LabSolutions

• Exposure to regulatory audits (USFDA, MHRA, WHO)

• Knowledge of forced degradation and stability studies