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This position is a quality function which supports GxP quality computer software implementation. &nbsp;This position requires a mid level individual with strong experience in supporting Computer System Validation (CSV) efforts ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs.&nbsp; The Validation lead partners with Business Owners, Technical Owners, Product owners and Quality testing team to create and manage validation deliverables for GxP applications.</p><p><strong>Responsibilities:</strong></p><ul><li>Coordinate and communicate between V&amp;V team and other departments, in particular Design Quality Assurance (DQA) and subject matter experts (SMEs).</li><li>Partners with and/or leads Business Teams and cross functional teams to ensure that computerized quality systems (specifically Salesforce Lightning) are compliant with ANSR MedTech corporate procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5</li><li>Creates and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, IQ Protocols, PQ Protocols, Test Protocols, Test Reports, test scripts, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment.</li><li>Strong knowledge of GAMP/risk-based approaches to validation (computer software assurance) and good understanding of electronic records.</li><li>Ensures that all validation deliverables are prepared in accordance with ANSR MedTech guidelines, policies, and procedures.</li><li>Familiar with diverse computerized systems such as ERP, MES, CRM, and validation life cycle management application.</li><li>Report status to the Test Management and Coordination Team lead for all ANSR MedTech V&amp;V team effort under his/her jurisdiction.</li><li>Supports Business Owners and cross functional teams in the definition and creation of Business Requirements, Functional Specifications and System Specifications as necessary.</li><li>Work with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, ISPE GAMP 5®, ANSR MedTech corporate policies and procedures.</li><li>Follows all ANSR MedTech policies, guidelines, and SOPs as required.</li><li>Reviews and complies with the ANSR MedTech Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws, and regulations.</li><li>Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.</li><li>Conduct Periodic review of GxP systems.</li><li>Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.</li><li>Thorough understanding of FDA Quality System regulations in relation to computer system validation.</li><li>Remains current on 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drive core engineering and platform development.&nbsp; &nbsp;</li><li>Sustainable, scalable ecosystems that nurture world-class MedTech talent. &nbsp;</li><li>Capability centers that directly influence patient outcomes worldwide.&nbsp; &nbsp;</li><li>At its core,&nbsp;the ANSR MedTech Capability Center is about enabling innovation that touches lives at scale.</li></ul><p><strong>About R&amp;D:</strong></p><p>The R&amp;D organization at ANSR MedTech is being built to support the development, testing, and long-term sustainment of complex, regulated products used at global scale.</p><p>This team plays a critical role in engineering excellence, product quality, and operational reliability, working closely with global R&amp;D leaders to deliver against well-defined technical standards, quality systems, and product outcomes.</p><p>Unlike a traditional offshore or support model, R&amp;D in India is designed to take on meaningful ownership across the product lifecycle, particularly in areas where scale, focus, and execution discipline are essential.</p><p><strong>What Makes This Opportunity Stand Out:</strong></p><ul><li>Work on real, production grade products that require high engineering rigor, reliability, and regulatory discipline.</li><li>Be part of a team that spans embedded software, mobile applications, systems engineering, test automation, and lifecycle engineering.</li><li>Contribute to end-to-end R&amp;D workflows—from development and verification through sustaining engineering and triage.</li><li>Help build and scale a new R&amp;D capability from the ground up, shaping labs, automation, ways of working, and quality culture.</li><li>Partner directly with senior global R&amp;D leaders and engineers, gaining exposure to how products are built and operated at enterprise scale.</li></ul><p><strong>How the R&amp;D Team Operates:</strong></p><ul><li>Teams are based in India and embedded in day-to-day delivery, not isolated support functions.</li><li>Technical 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