Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Languages
Timeline
Generic

Irma Villarreal Castillo

San Antonio,TX

Summary

Demonstrate competency in writing and reviewing the CMC regulatory submission documentation (IND, IMPD, NDA, BLA) and answer CMC regulatory questions Cross-functional regulatory collaborator with ability to consistently deliver high quality ‘right first time’ documentation. High level of accountability and a 'can-do' attitude. Excellent attention to detail. Strong scientific background. Effective communication skills. Customer service/relationship management (including negotiation) skills. Patient/consumer focused. Project management skills. Dynamic multi-tasker. Proactive decision maker. Adaptive learner (continuous improver). Fluency in English/Spanish (excellent written and spoken)

Overview

1
1
year of professional experience
1
1
Certification

Work History

Sr. Certified Quality Systems IT Auditor

01.2004 - 01.2005
  • Determine the adequacy of access controls, physical access controls, data input/output controls, system controls, information security, business continuity and the degree of compliance to regulations
  • Maintain direct communication with audit clients during field work and presenting completed detailed reports of audit findings and recommendations
  • Follow and practice all personnel and Quality Management System practices to ensure that FDA, ISO and European Medical Device quality standards and regulations are met, where applicable
  • Promoted through positions of increasing responsibility based on strong performance as an auditor and ability to successfully manage complex projects and lead audit teams
  • Manage audit projects effectively, monitoring and reporting on project status to help assure timely completion of annual audit plan
  • Design audit strategies and programs including audit purpose, scope, and audit approach/methodology for assessment of the company's numerous and varied operations and processes based on analysis of risk
  • Provide guidance on testing strategy, auditing techniques, and sampling methodology
  • Review work performed to ensure audit observations and recommendations are based on sufficient, competent, relevant data in accordance with auditing standards
  • Communicate audit results orally and in formal reports to various levels of management
  • Establish and maintain effective working relationships with unit, department, and division management, as well as external auditors
  • Plan and perform internal audits of all facets of business operations including highly sensitive subjects such as officer expenses, compensation disclosures, and attorney/client privileged audits
  • Make sound management decisions regarding compensation, recruitment, selection, promotion, training, awards, assignments, and discipline
  • Assemble and allocate audit staff to project, including monitor and reporting of medical device audit progress and results to stakeholders
  • Determine compliance with national and international quality standards and legislation
  • Create and execute IT validation plans, IQ, OQ, and PQ test scripts.

Education

Master’s degree - Medicine

Stanford University School of Medicine
Palo Alto, CA

Bachelor’s degree - Microbiology

University of Texas at San Antonio
San Antonio, TX

Skills

  • Vulnerability Assessment
  • Security Awareness Training
  • Security Policies
  • Access Control

Certification

  • Lean Six Sigma Certified Green Belt
  • Certified IT Quality Systems Auditor
  • Certified Simultaneous and Consecutive Translator

Affiliations

PHI BETA KAPPA

Languages

Spanish
Native or Bilingual

Timeline

Sr. Certified Quality Systems IT Auditor

01.2004 - 01.2005

Master’s degree - Medicine

Stanford University School of Medicine

Bachelor’s degree - Microbiology

University of Texas at San Antonio

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Irma Villarreal Castillo