Computer System Validation SpecialistLABUR • Bedford, MA, US
Computer System Validation Specialist
LABUR • Bedford, MA, US
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job_description.job_card.job_description3+ years of experience in computer system validation. Familiarity with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards. Strong understanding of software development and validation lifecycle. Excellent documentation and technical writing skills. Strong analytical and problem-solving capabilities. Ability to work independently and in a team environment. Seniority level : Mid-Senior level Employment type : Contract Job function : Information Technology Industries : IT Services and IT Consulting
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Our client is seeking a Computer System Validation Specialist who will play a crucial role in ensuring that IT systems comply with regulatory guidelines. This role involves the validation process, including creating and executing test plans, documentation, and change control, to maintain data integrity and compliance standards.
Key Responsibilities
- Develop and execute validation protocols for computer systems.
- Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards.
- Create detailed validation documentation including plans, reports, and scripts.
- Conduct risk assessments and impact analyses related to computer systems.
- Coordinate and supervise testing activities.
- Collaborate with cross-functional teams to maintain and improve system validation processes.
- Monitor and report on validation project progress.
- Provide training and support to staff regarding validation processes and requirements.
Qualifications
Additional Details
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