Amar P.

Background

About Amar P.

Analytical Data Review. • Review of Stability Protocols, analytical data reports. • Review and release of Raw material, Packing material, IPQC samples, Finished product, Stability data, Drug substance and Drug product. • Review of Bio-analytical Data Such as VEGF-ELISA, HUVEC ASSAY, PURITY BY SDS PAGE, Glycan, SEC, cIEF, Ion Exchange chromatography and Peptide Mapping. • Review of Microbiology raw data like sterility, BET and water release. • Review of Qualification /Calibration data of instruments. • Review of Development Protocols, analytical data and reports. • Review of AMV Protocol, observe ongoing Method Validation and Review Reports and check compliance. • Observe and Review Analytical of Tech Transfer data. • To take part in Qualification of QC Instrument/Equipment for reviewing and compliance. • Review of IMPD Report and RMP Survey. • Visual Inspection QMS and Compliance • Review of QMS Documents Related to QC for Compliance.(non-conformance's,) • Issuance of OOS, OOT andEnsure Investigation of out-of-specification, out of trend, on conformity process, Out of calibration, deviations and batch Failures Are Appropriately performed and CAPA has been Implemented and Documented. • Quality Agreements of the Service Giver (CTL,CRO And Calibration ) • Review of Change Control, CAPA and check implementation. Documentation • Competency Development with the GLP System and procedure, Specification, Test procedure, Calibration, Pharmacopeia and related Guidelines in QC. • Preparation and updation of QA SOPS. • Review of SOPs and IOPs related to QC/QA/Information Technology. • Review of Analytical Method Qualification Protocol and Report. • Review of Raw material, Packing material, IPQC, Finished product, Drug substance and Drug product Specification and updation as per Pharmacopoeias Revision.