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

- Valuable 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

📌 Method Validation Analyst ( Hplc/Gc (Bengaluru)
🏢 RECEX
📍 Bengaluru