Rahul Gholap

About Rahul Gholap

Accomplished QA and IT Compliance professional with over 25 years in the pharmaceutical…

Experience

1. Senior Manager Qa

   Biocon

   Aug 2020 — Present · Bengaluru, IN

   Leading QA functions for QMS, CSV, and equipment/system qualification.Reviewing and approving QMS records (Change Controls, Deviations, CAPAs, Investigations) with timely closure.Collaborating with cross-functional teams (Quality, IT, Engineering, Production) to resolve QMS issues efficiently.Validating and implementing enterprise systems like LIMS, SDMS, TrackWise, DMS, SAP, and MES.Ensuring regulatory-compliant qualification of computerized systems (e.g, Instruments, SCADA, PLCs).Leading SOP review, approval, and training to ensure compliance with regulatory standards.Managing changes and revalidations post system implementation.Developed and implemented CSV SOPs in line with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.Guiding Quality and IT teams on CSV/qualification strategy and issue resolution.

Education

• Ahmednagar College, Ahmednagar

  M.Sc., Drug Chemistry

  1997 — 1999

Skills

• U.s. Food and Drug Administration (Fda)
• Glp
• Capa
• Lims
• Gxp
• Quality Auditing
• Software Documentation
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Requirements
• Quality System
• V&V
• Computerized Systems
• Software Development Methodologies
• Quality Assurance
• R&D
• Quality Control
• Gmp