Vinay Patil

About Vinay Patil

Experience: Working as a Head Global Audits and Compliance - CQA. Experience of more than 200 audits specifically; Internal Audits, Due diligence, CMO, Vendor and CTL. Subject matter expert for Sterile and microbiology.Worked for compliance for USFDA, MHRA and EUGMP. Responsible for all time readiness. Experience in Quality Assurance and Validations scenario in pharmaceuticals specially, sterile dosage forms, sterile API\'s and biologic\'s. Worked with regulatory environment of firms having the certifications of USFDA, MHRA, EUGMP, etc.Worked as a team leader of Validation and Qualification Program in sterile/non-sterile/Biotech facility, Newly renovated facility. Having the exposure of Regulatory audit preparations, compliance, compliance verification. Having the experience in following work scenario:1. New facility renovation and project completion w.r.t. regulatory norms.2. QMS (Change control, Deviation, Incidents, OOS, CAPA)3. Risk assessment, Commissioning, FAT, Vendor Inspection.4. Investigation through QMS channel for RCA related to utilities, sterile processing, microbiology.5. Expertise in Equipment qualification: URS, DQ, FAT, IQ, SAT, OQ, PQ.6. Validations HVAC, PW, WFI, PSG, Isolators,Lyophilizers, Compressed gases, SCADA, Software/PLC, Facility, Aseptic Media FIll, sterilization, Contentment,cleaning and process validations.

Experience

1. Director

   Cipla

   Jun 2024 — Present · Mumbai, IN

Education

• North Maharashtra University

  M.Sc, Biotechnology

  2003 — 2008

• NIBM India

  MBA in Operations (QMS)

  2009 — 2011

Skills

• Change Control
• Equipment Qualification
• Validations, Risk Assessment, Audit Compliance.
• Glp
• Capa
• Quality System
• V&V
• Microsoft Office
• Cleaning Validation
• Audits and Compliance
• Gmp
• Validation
• Vendor Qualification
• Sterilization
• Lyophilization
• Deviations
• Pharmaceutical Industry
• Sop
• Fda
• Technology Transfer
• Quality Assurance