Sanjay Sable Email and Phone Number

• Shelf Life extensions and reductions of commercial drug products.• Stability data trending for investigations and for Annual Stability Summary Review packages for APQR’s.• Interpret statistical data analysis by using ANCOVA from LIMS-NWA software.• Provide Annual Stability Review contribution packages to QA for APQR’s.• DTC for GQC-Stability Dada Analytics.

• Co-ordination of Process Validation Samples which includes all stages like Feasibility trial batches, scale up batches, IPHT samples, In-Process, Bulk, Exhibit batches, Filling & sealing, Compression stages, Commercial Validation samples, Protocol base study samples of various blocks (A,B,C,P& PDL) as per applicable STP’s/SOP’s, GP’s & followed stockholder requirements.• Initiation and track of Investigations, Deviations, OOS, OOT, CCR, CAPA, RCA in QMS Track wise software.• Responsible for day to day releases of Process Validation samples with strong coordination with production, QA and PDL.• Training co-ordinator for process validation department.

• Review of Analytical worksheet and reports for Raw Material and Finish Product samples.• Analytical test data sheet preparation, merging and uploading in SAP.• Analysis of Raw Material and Finish Product samples.• HPLC & GC column management.• Solid & Liquid Chemical management.• Raw Material, Finish Product Stability samples management.• Submission of data to regulatory by following regulatory commitment.