ResponsibilitiesLiterature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols  Coordinate with the CRO for finalizing pilot and pivotal biostudy protocol for DCGI BE application. Develop protocol for patient based BA/BE studies & PD end point study for complex generics. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software. Use modeling & simulation tools for study optimization. Respond to regulatory queries related to PK analysis and study interpretation.Qualification & ExperienceGraduate : M.Pharm /Pharm D Experience Tenure : Minimum 3 years of relevant experience

ResponsibilitiesThe candidate is expected to develop Surface Plasmon Resonance (SPR) based methods to measure the kinetic and equilibrium binding constants for protein and peptide products. Responsible for analytical method qualification for all pipeline products. Characterization of innovator product batches sourced from different geographical region and preparation of qualitytarget profile. Analytical similarity assessment of in-house products. Preparation of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. The candidate is responsible for the operation and maintenance of the SPR instruments  To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issueQualification & ExperienceM.Sc. Experience Tenure : 2-4 yrs

ResponsibilitiesAssess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down for API Panoli site . Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation includingrelease of raw materials, intermediates, in?process samples, APIs, and monitoring API stability as per regulatory commitments.Ensure analytical methods (for intermediates and APIs) are validated/transferred as per ICH Q2 and API regulatory requirements.Monitor and review investigations and QMS with adequate CAPA to minimize errors. Qualification & ExperienceB.Pharm / M.Pharm Experience Tenure : 18+ Yrs