Dhaval Shah

About Dhaval Shah

Organized, result oriented Pharmaceutical Professional with more than 10 years of experience in ValidationEngineering, Quality (QA/QC), Project Management (Budget/ Project Timeline/ Resource Management), and Consulting within biologics, small molecules, Oral Dosage. Expert in equipment, process and computer system validation along with excellence in documentation and problem solving methods Excellent understanding of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, ASTM-E2500, FDA and ICH guidelines. Active member of ISPE and PDA organizations Success-driven project manager with team-building skills along with efficient time management skills inmeeting deadlines in job completion while paying attention to details necessary for quality work Experienced consultant with strong interpersonal skills, capable of working well under pressure and able to connect with clients, peers, and management with a positive attitudeSkills: Validation: Expert in Equipment Validation, Computer System Validation, Process Automation, CleaningValidation, Process Validation, Method Validation Documentation: Proficient in writing SOPs, Change Control, URS/ FRS, Validation Master Plan, QualificationProtocols (IQ/OQ/PQ), RTM (Requirement Traceability Matrix), Deviations, Summary Reports, CAPA, ImpactAssessment and Risk Assessment documents Computer Softwares: Proficient with business applications (Trackwise, EDMS, QDoCCS, Sharepoint, LIMS,Minitab), manufacturing/process softwares (BMS, SCADA, PLC, Pi Historian) as well as Microsoft office tools

Experience

1. Associate Director, Validation

   Vertex Pharmaceuticals

   Jul 2022 — Present · Boston, MA, US

Education

• Gujarat University

  Bachelors, Pharmacy

  2005 — 2009

• New Jersey Institute of Technology

  Master of Science, Pharmaceutical Engineering

  2009 — 2011

Skills

• Change Control
• Gxp
• Aseptic Processing
• Pharmaceutics
• Cip
• Process Manufacturing
• Cleaning Validation
• Cgmp
• Project Management
• Iso
• Pharmaceutical Industry
• Sop
• Product Validation
• Fda
• Pharmaceutical Development
• Computer System Validation
• Lean Manufacturing
• Hplc
• Documentation
• Capa
• Uv/Vis
• 21 Cfr Part 11
• Regulatory Affairs
• Quality System
• V&V
• Analytical Techniques
• Software Documentation
• Root Cause Analysis
• Validation
• Validation Documentation Life Cycle
• Biotechnology
• Process Engineering
• Auditing
• Sop Writing
• Calibration
• Dissolution
• Qualification Protocol Writing (Iq/Oq/Pq)
• Wet Chemistry
• Nlcp
• Gamp