<p>We respectfully request that 3rd parties refrain from contacting us regarding this posting.</p> <p>Overview:</p> <p>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 resource will be responsible for the validation process, including the creation and execution of test plans, documentation, and change control. This role will be central to maintaining data integrity and compliance standards in our systems.</p> <p>Key Responsibilities:</p> <ul> <li>Develop and execute validation protocols for computer systems. </li><li>Ensure compliance with regulatory requirements and industry standards such as FDA 21 CFR Part 11, GxP, and ISO standards. </li><li>Create detailed validation documentation including plans, reports, and scripts. </li><li>Conduct risk assessments and impact analyses related to computer systems. </li><li>Coordinate and supervise testing activities. </li><li>Collaborate with cross-functional teams to maintain and improve system validation processes. </li><li>Monitor and report on validation project progress. </li><li>Provide training and support to staff regarding validation processes and requirements. </li></ul> <p>Qualifications:</p> <ul> <li>3+ years of experience in computer system validation. </li><li>Familiarity with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards. </li><li>Strong understanding of software development and validation lifecycle. </li><li>Excellent documentation and technical writing skills. </li><li>Strong analytical and problem-solving capabilities. </li><li>Ability to work independently and in a team environment. </li></ul>