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Key Responsibilities

Method Development & Validation

Develop and validate robust analytical methods (Assay, Related Substances, Dissolution, Residual Solvents, Uniformity) for active ingredients, raw materials, and finished product formulations.

Prepare comprehensive Method Validation Protocols (MVP) and Method Validation Reports (MVR) following ICH guidelines (Q2(R1)).

Optimize existing analytical procedures to enhance accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ).

Instrumental Analysis & Testing

Perform routine and non-routine analysis using HPLC, GC, UV-Vis Spectrophotometer, FTIR, Dissolution Apparatus, and Karl Fischer Titrator.

Conduct forced degradation (stress testing) studies to establish stability-indicating properties of developed analytical methods.

Execute analytical testing for forced degradation, impurity profiling, and stability study samples (accelerated and real-time conditions).

Regulatory & Documentation Compliance

Author Standard Operating Procedures (SOPs), Standard Testing Procedures (STP), Specifications, and Method Transfer Protocols.





Ensure strict compliance with cGMP, GLP, and internal safety protocols within the ADL unit.

Maintain complete and audit-ready laboratory records, raw data notebooks, chromatograms, and logbooks.

Method Transfer & Calibration

Facilitate seamless analytical method transfer (AMT) from ADL to Quality Control (QC) or commercial manufacturing sites.

Perform routine calibration, preventive maintenance, and troubleshooting of analytical instruments.

Assist in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation workflows.

Experience 2 - 3 Years Salary 2 Lac To 3 Lac P.A. Industry Analytic and Business Intelligence Qualification M.Pharma, M.Sc Key Skills Analytical Executive Analytical Method Development Analytical Analytical Instruments Analytical Chemistry

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Analytical Development Executive (Nashik)
🏢 Impact Hr N Km Solutions
📍 Nashik