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SVT Compliance Analyst (Hybrid)

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Primary Location: Durham, North Carolina, United States Full time R1325939

Job description

Job Overview
This position is responsible for direct interaction with internal customers to determine hardware, software and system requirements and to deliver these as GXP systems. They will define and analyze system needs/problems; design and
test standards and solutions, create SDLC documentation, and ensure validation documentation meets GxP requirements

Essential Functions
• Performs and oversees software project validation in line with departmental SOPs and guidelines.
• Validates results by creating testing programs, test cases; performing and/or coordinating with a team of users to execute test cases as needed
• Ensures system compatibility with operations, IT, users, vendors, etc. by training client personnel; providing ongoing support.
• Ensures SDLC validation documentation content is complete, maintained and meets GxP requirements.
• Authoring and/or contributing to all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
• Accomplishes information systems and organization mission by completing related results as needed.
• Coordinate with applicable parties when working through software issues/defects and resolution paths.
• Providing standardized templates, guidance, and overall validation direction supporting various programs

Qualifications
• Bachelor's Degree Computer Science, a related field or equivalent experience in a medical, clinical, pharmaceutical or analytical setting
• Over Five (5) years related experience in Software Validation

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

“I know Q2 Solutions offers me a great career path with lots of options. My line manager fully supports my growth.”

Marianne H, Associate Laboratory Project Set-Up Manager

“There are tremendous opportunities to grow here. If you are driven, passionate and committed, the sky’s the limit.”

P. Surve, Clinical Process Team Lead

“What gets me most excited about being part of Q2 Solutions is working with cutting-edge technologies that help patients and further innovation in the field.”

Todd L., Scientist

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