Job openings for Analytical Development Executive in Nashik

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.