Brijal Patel

About Brijal Patel

Ten years of cGMP experience in Pharmaceutical, Biologics and Biotechnology Industry. Have extensive knowledge of product release, SOP writing, ensuring compliance to CFR Part 210, 211,820, cGMP, ICH guideline and perform internal Audit. Experienced compliance officer that resolves Deviations/Non-Conformance (NC), Customer Complaints, Lab Investigations and CAPAs. Provide SME Support, backroom and front room support during External and Corporate Audit. Proficient in Microsoft Office and can generate advance level of metrics.

Experience

1. Quality System Specialist Iii

   Gilead Sciences

   Feb 2024 — Present · Foster City, CA, US

   Independently authored and managed investigations, conducting impact assessments, root cause analyses, and CAPA development to ensure timely closure and compliance.• Facilitated daily ICT huddles and presented morning metrics to drive team accountability and investigation progress.• Sent periodic notifications to stakeholders (Owners, Approvers, Functional Area Approvers) to ensure investigations closed on time.• Supported continuous improvement initiatives, including Smartsheet development and Decision Tree updates to streamline triage processes.• Generated monthly Quality System Scorecard metrics to monitor performance and identify trends.• Cross-trained on Clinical Site Excursion (SE) processes; led triage meetings, collaborated with internal and external teams, documented impact assessments and product disposition, and routed SE records for approval.

Education

• Rajiv Gandhi University of Health Sciences

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2006 — 2010

Skills

• Microsoft Office
• Quickbooks
• Standard Operating Procedure (Sop)
• Sas Programming
• Data Analysis
• Good Laboratory Practice (Glp)
• Sql
• Macro
• Trackwise
• Sop
• R&D
• Quality Assurance
• Dissolution
• Maximo
• Quality Control
• Gmp