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Member Resumes
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Recent Pharmaceutical Computer and Automation
Quality Assurance Work

  • Created remediation strategies for legacy computer systems regulated by USA, Canadian, European, Australian, and Japanese authorities.

  • Developed risk based validation strategies for new systems.

  • Provided guidance for implementation of electronic records and electronic signatures.

  • Wrote policies, guidelines, and procedures to implement new and legacy computer system validation.

  • Developed risk assessment strategies and tools that help customize validation approaches for computer systems and spreadsheets.

  • Audited computer system developmental and operational policies, procedures and practices.