Samir Patel

About Samir Patel

Samir Patel has over 20 years of multifaceted experience in the Life Science industry. Samir has led many consulting projects for life science clients that range from the leading IT, IT QMS, and CSV initiatives for Life Science M&A\'s, Global IT operations process development, creation of CSA/QMS programs, an IT-based Data Integrity program for lab systems operations to the implementation and validation of numerous lab systems and enterprise applications. Samir has also successfully participated and presented in numerous FDA and International Regulatory Authority audits. Samir is an active member of ISPE, a member of the East Carolina School of Computer Science Corporate Advisory Board, and an active angel/real estate investor. When not working Samir enjoys spending time with his Wife and two young children.

Experience

1. Senior Director Csv & IT Compliance

   Alliance Biotech Solutions

   Jul 2024 — Present · US

   Spearheaded IT and CSV projects to enhance operational efficiency and compliance across the client organization. Supporting systems such as: Veeva Vault, Numerous Lab Systems, ComplianceWire, Blue Mountain RAM, Kneat, ServiceNow, Cytiva Chronicle, LabX• Drove business development initiatives, resulting increased client engagement and satisfaction. • Collaborated with cross-functional teams to align technology solutions with organizational growth objectives.

Education

• Beddingfield high school

  High School

  1993 — 1997

• East Carolina University

  B.S, Computer Science

  1997 — 2001

Skills

• V&V
• Gxp
• Standard Operating Procedure (Sop)
• Biotechnology
• Medical Devices
• Capa
• Quality Control
• Gmp
• 21 Cfr Part 11
• Lims
• Computer System Validation
• Change Control
• Validation
• Testing
• Corrective and Preventive Action (Capa)
• U.s. Food and Drug Administration (Fda)
• Software Documentation
• Automation
• Pharmaceutical Industry
• Sop
• Fda