Kailas N.

India

Summary

KAILAS NARALE 9,Kshitij Kudale-PatilS.V No-53/2/1,Vadgaon B.K PUNE- -411041 Phone: (020)24352883, Mobile: (+91) 98 60 36 36 66 Email: kvnarale@gmail.com CAREER SUMMARY Summary Skilled Quality management system Head of Dept with extensive experience in the Pharmaceutical formulations/ Vaccine Biotech Industries. Experienced in QA 25 years in Quality management. • An excellent planner and organizer with the ability to manage a staff of Quality QA/QC/RA Staff to reach goals while strictly adhering to budgets and, cGMP, GLP, GCP and ICH / Post Approval Inspections, FDA, USP, EP,JP requirements. • Perform GAP analysis and site audit report and compliance with CAPA.Pharmaceutical firms. • Responsibilities- Vendor Qualification, Global Trainer – Training planning, Review of APQR, Equipments-Qualification, Analytical Validation, Process Validation ,Photostability, Stability Stability study. Approval Quality policy /Manual ,preparation of MVP, BMR MFR, SOP approval authorization /Change Control, OOS /deviation ,Rejection ,Disposals , Preparation of DMF/ SMF COS/CTD, Registration Product to FDA .Regulatory authorization ,. • Review planning Monitoring, tracking, Quality operation with respective production in timelines, budgets, etc • More than 24 years in management positions for Quality Control / Quality Assurance / R&D / Regulatory Affairs with multi-national bio pharma/ pharmaceutical companies. • Contract manufacturing, Technical Services & Business development and support to export and technical support to Customer. • During the past 20 years, provided laboratory management through all governmental inspections e.g. FDA, CDSCO and international auditor from Germany, French, Hungary, Brazil canda/USA. • Self-starting, team player with strong training ability .Extensive Staff training experience

Experience

  • monitoring / evaluation
  • events / training
  • industry / manufacturing
  • medicine
  • development
  • brazil
  • hungary
  • germany
  • Sectors
  • Funders
  • Countries
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