Indu Sharma Email & Phone Number

A leader in Project management, Quality Control, Managing Manufacturing/operations, training, Product transfer to CMO and setting up cGMP labs for mfg/QC.Connect with me by sending an email at ►►► sharmai1980@gmail.com ◄◄◄All Invitations to Connect Welcome****************Presidents, CEOs, COOs, Directors, VPs, Manufacturing Directors, Project Managers, Recruiters, HR Managers, Hiring Managers to connect with me to get access to my network deep in industry leadership.****************Quality and manufacturingarea professional with 20+ years’ experience in diagnostic &biopharmaceutical products. Experience entails validation and technicaltransfer of reagent manufacturing activities and QC method transfers to CMO.Preparing and maintaining manufacturing and QC documentation to meetcompliance. Specialties:* Strong analytical and problem-solving skills* Expert in Product transfer, Assay transfer, and equipment validation* Review of executed BHR for product disposition, analyticaltest records, data analysis, and performing trend analysis.* Managing Stability studies, method Validations, and Vendorqualifications.* Initiating, writing reports for the closure of deviations, CAPA,and NCMR * Initiating and/or updating SOP, DOP, Test method, protocol,report and specifications through Change control.* Hands-on experience with BioAssays, Elisa, PCR, Genotyping,tissue culture, and analytical methods. QC testing for incoming raw material,formulation, in-process testing, and final product release* Internal audit, ISO13485, FDA* Proficient in Microsoft Office products (i.e. Excel, Word, and PowerPoint)* Setting up Item master, BOM, routing, WO, Cost analysis, review WO Varianceand planning* Certified in Lean and Six Sigma and experienced in implementation* Calibration and Preventative Maintenance * Time management* Improve efficiency via continuous improvement * User verification testing for SW application implementation* Experienced in using different document control systems e.g. Documentum,share point, Q-Pulse, Veeva, EDMS, PDM, Compliance Quest.

Listed skills include Gmp, Fda, Capa, Validation, and 44 others.