Jehanzeb Zafar

About Jehanzeb Zafar

Servant leader : with EXTENSIVE experience in Quality Compliance FDA regulatory + Project And Program Management + Lean Six Sigma continues improvement and process improvement.

Experience

1. Csv - Qpm

   Novartis

   May 2025 — Present

   CQV CSV QPM (mostly focused on CSV portion) Leading a team of consultants, defining strategy on how to perform CSV activities and do leveraging between two Robotic Nuclear Production and Packaging lines and their Intergrations.Planning, Owning, Reviewing, Authoring, updating deliverables such as Migration Plan (DQ to Commissioning & Commission to Qualification), URS, FRA, FDS, SFDS, Config Specification, IQ, OQ, PQ. Working Hand in Hand with the ITOT team with shared responsibilities for Validating the Software on these Robotics Lines.Working closely with BPO, Facilities and MSAT. Focus on CAPA. Deviations, Project Change Controls. Directly working with BPO and MSAT to get BPM and other deliverable updated, changed, captured and tested.

Education

• Chicago State University

  BS ( CS ), Computer Science , Physics

Skills

• U.s. Food and Drug Administration (Fda)
• Iso 13485
• Board Relations
• Gmp
• Medical Devices
• Capa
• Validation
• Trend Forecasting
• U.s. Title 21 Cfr Part 11 Regulation
• Minitab
• Standard Operating Procedure (Sop)
• Six Sigma
• Sop
• Fda
• Quality System
• V&V
• Project Portfolio Management
• Itil
• Ncr
• Contract Manufacturing
• Corrective and Preventive Action (Capa)
• Salesforce.com Implementation
• 21 Cfr Part 11
• Computer System Validation
• Performance Benchmarking
• Training & Development
• Resource Development
• Strategic Planning
• Budget Monitoring
• Software Documentation
• Sap
• Itil V3 Foundations Certified
• Quality Assurance
• Verification and Validation (V&V)
• Change Control