Senior Validation Analyst

• Evaluate an impacted system, participate in risk assessments to understand the impact to regulatory compliance, and establish a Validation Plan to validate the product for operational use.
• Ensure the system meets the specified requirements per the process defined in the Validation Plan.
• Draft test cases and scripts to meet Operational Qualification and Performance Qualification Testing objectives based on the system requirements.
• When necessary, execute scripts to ensure the system release candidate functions as expected.
• Report defects and problems, as per the Validation Plan.
• Assist the project team to complete validation activities following Good Documentation Practices.
• When necessary, participate as a Software Tester in verification activities to identify defects and ensure the system meetings requirements.

• 7 years of experience in writing validation plans, protocols, test scripts, and summary reports.
• Strong knowledge of deliverables that a GxP system upgrade validation should provide, including validation plan, risk assessment, protocols, etc
• Strong knowledge of deliverables that would be found in a validation binder for a system upgrade.
• Knowledge of FDA regulatory requirements and how they apply to IT Systems.
• Knowledge of software testing methods and best practices.
• Knowledge of Good Documentation Practices.
• Ability to program simple to moderate SQL scripts
• Experience using risk management as an approach to developing test cases and focusing testing efforts.
• Minimum three years' experience in Clinical, Medical, or Pharmaceutical space.
• Experience in the use of Rational tools is a plus.
• Experience in verifying Section 508, 21CFR11, GAMP5 or other regulatory requirements is a plus.
• Flexibility in accepting special assignments including Business Analysis and Software Testing tasks.

Last updated on Mar 21, 2017