Job Description:

Key Responsibilities

Method Validation & Development

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

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

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Conduct method verification and method transfer activities

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Prepare and review validation protocols and reports

Instrumentation & Analysis

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

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

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Troubleshoot analytical and instrument-related issues

Documentation & Compliance

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

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

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

Laboratory Practices





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Ensure proper calibration and qualification of analytical instruments

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Maintain laboratory cleanliness, safety, and compliance

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Train junior analysts as required

Required Skills & Competencies

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Strong hands-on experience with HPLC and GC

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Positive knowledge of ICH, USP, EP, FDA, and EMA guidelines

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Experience in method validation, troubleshooting, and data interpretation

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Knowledge of data integrity (ALCOA principles)

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Proficient in documentation and report writing

Preferred Skills

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Experience with software such as Empower, ChemStation, or LabSolutions

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Exposure to regulatory audits (USFDA, MHRA, WHO)

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Knowledge of forced degradation and stability studies

📌 Method Validation Analyst (Bengaluru)
🏢 RECEX
📍 Bengaluru