USDM is looking a strong Validation resource to support validation projects for cloud based (SaaS) clinical applications and lead the efforts of offshore testing support.
Job Description • Develop and execute system validation scripts based on software/hardware configuration for enterprise systems • Update application system User Requirements, Functional, and Design Specifications • Develop Installation Qualifications scripts based on Design • Develop Operation Qualifications based on functional requirements • Develop Performance Qualification scripts based on configuration • Route validation documentation • Manage Tasks based on aggressive timelines • Interact with customers at multiple sites • Interact in team environment
Qualifications • Experience with validation implementation, preferably clinical systems knowledge. • 3-5 years of experience, with some lead exp. • Minimum BA / BS or relevant work experience in information systems, engineering, science or business. • Validation experience with computerized systems in the pharmaceutical industry. • Excellent oral and written communication skills. • Strong technical background – familiar with writing queries • Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice. • Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices. • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. • Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner. • Ability to work independently with minimal supervision.