Opening For Analytical Development Executive

Key ResponsibilitiesMethod Development & ValidationDevelop 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 & TestingPerform 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 ComplianceAuthor 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 & CalibrationFacilitate 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.Experience2 - 3 YearsNo. of Openings3EducationPost Graduate (M.Pharma, M.Sc)RoleAnalytical Development ExecutiveIndustry TypePharma / BioTech / Clinical ResearchGender[ Male / Female ]Job CountryIndiaType of JobFull TimeWork Location TypeWork from OfficeFace Interview LocationImpact HR and KM Solutions Near Canada Corner Signal Ravi Chambers Basements Below Laminate Gallery, Nashik