System Validation Expert

5 days ago


San Francisco, California, United States Volt Full time

Innova Solutions is currently seeking a System Validation Expert to join our team. This role will play a crucial part in ensuring the quality and compliance of our systems, working closely with cross-functional teams to deliver technical solutions that meet regulatory requirements.

Job Description:

The System Validation Expert will be responsible for authoring and revising validation documents, executing protocols, and collaborating with stakeholders to ensure seamless system implementation. Key responsibilities include:

  • Authoring and revising User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, Installation, Operational and Performance Qualification protocols
  • Executing authored protocols and ensuring compliance with regulatory requirements
  • Developing decommissioning and data migration strategies for legacy systems
  • Collaborating with cross-functional teams on CAPAs and Deviations
  • Maintaining system-specific operational documentation, including SOPs and work instructions

Requirements:

To be successful in this role, you will need:

  • A minimum of 5 years of experience working in an FDA-regulated environment, validating computerized systems
  • Experience in computer system validation using GAMP 5 methodology
  • Good understanding of 21 CFR part 11 and Annex 11 regulations
  • Experience with validation methodologies and SDLC best practices

Benefits:

We offer a competitive salary range of $65-$70 per hour, as well as a comprehensive benefits package, including medical, dental, vision insurance, 401(k), HSA, FSA, life insurance, pet insurance, short-term and long-term disability, accident, and critical illness coverage.

About Innova Solutions:

Innova Solutions is a leading provider of technology and business transformation solutions, employing over 50,000 professionals worldwide. We are committed to delivering high-quality services that meet the needs of our clients, and we strive to create a positive work environment for our employees.



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