Analytical Development Laboratory Position: Executive Experience: 3-8 years Qualification: M.Sc. / M.Pharm. Job Responsibilities: HPLC/GC/IC method development, feasibility, verification, equivalency, validation of API for complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vendor methods versus existing primary vendor and regulatory impact analysis Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation Good understanding and hands on experience of analytical instruments like HPLC, IC, GC etc. NI/GI & NDSRI' with LCMS/GCMS expertise, Solid state characterization and API sameness study Hands on experience on In-vitro Studies, E&L, Solid State characterization, IVPT/IVRT, Impurity characterization, sameness study Well versed with USP/EP/BP/JP and various current regulatory guidelines (ICH/EMEA/FDA) Perform maintenance and calibration of lab instruments / equipment. Formulation & Development Position: Executive Experience: 3-8 years Qualification: M.Pharm. Job Responsibilities: OSD, Oncology, Alternative vendor development, Exposure of Regulated, Semi Regulated & India Markets FnD Documents like Specifications, MFC,BMR, Stability protocol, CCF , Deviation etc. (For FnD doc cell), Knowledge of SAP, loading of Specification in SAP, BOM loading, Stock overview, PR generation etc.
