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About the role
Role Overview: As a TrackWise Consultant, your responsibility will be delivering end-to-end TrackWise Digital implementations, from requirements gathering and solution design through configuration and testing. You will closely collaborate with client business, IT, and quality stakeholders to translate business needs into compliant system solutions. Your role will involve developing GxP documentation, supporting validation activities (IQ/OQ/PQ), conducting system demos, and ensuring high-quality delivery aligned with regulatory and quality standards. Additionally, you will contribute to project execution within agile delivery teams, supporting testing, defect resolution, and continuous improvement across quality processes. Key Responsibilities: - Collaborate with client business and IT stakeholders to understand business requirements and translate them into clear user stories - Develop functional specifications and technical designs aligned to defined requirements - Configure, build, and deploy TrackWise Digital solutions based on approved technical designs - Conduct system demos and playback sessions with client business and IT teams - Perform system configuration testing, support code reviews, and manage merges - Support creation, execution, and defect resolution for User Acceptance Testing (UAT) and validation testing (IQ/OQ/PQ) - Prepare, review, and maintain GxP-compliant documentation, including functional specifications, configuration documents, and validation artifacts - Ensure solution design and delivery adhere to quality and regulatory requirements in regulated Life Sciences environments - Support project management activities including task tracking, status reporting, risk/issue management, and delivery coordination Qualifications: - Bachelors degree in computer science, Electrical/Electronic Engineering, Information Technology, or a related field (or equivalent) - Minimum of 5+ years of relevant experience as a TrackWise / Quality Systems Consultant - Experience working in GxP-regulated Life Sciences environments with exposure to quality systems - Knowledge of global drug safety regulations including FDA, EMA, ICH guidelines - Detail-oriented with excellent data entry and organizational skills - Ability to work independently and as part of a team in a fast-paced, regulated environment - Strong communication skills to interact effectively with internal teams and external stakeholders - Proficiency for dashboard and PV related analytical reports creation using Power BI and similar tools - Willingness to work flexible hours or shifts if required Additional Details: EY is dedicated to helping clients from start-ups to Fortune 500 companies, and the work is as varied as they are. You will get to work on inspiring and meaningful projects with opportunities for personal development and growth. EY emphasizes high quality, knowledge exchange, and offers support, coaching, and feedback from engaging colleagues. You will have opportunities to develop new skills, progress your career, and handle your role in a way that suits you best. EY is committed to building a better working world by creating new value for clients, people, society, and the planet. Role Overview: As a TrackWise Consultant, your responsibility will be delivering end-to-end TrackWise Digital implementations, from requirements gathering and solution design through configuration and testing. You will closely collaborate with client business, IT, and quality stakeholders to translate business needs into compliant system solutions. Your role will involve developing GxP documentation, supporting validation activities (IQ/OQ/PQ), conducting system demos, and ensuring high-quality delivery aligned with regulatory and quality standards. Additionally, you will contribute to project execution within agile delivery teams, supporting testing, defect resolution, and continuous improvement across quality processes. Key Responsibilities: - Collaborate with client business and IT stakeholders to understand business requirements and translate them into clear user stories - Develop functional specifications and technical designs aligned to defined requirements - Configure, build, and deploy TrackWise Digital solutions based on approved technical designs - Conduct system demos and playback sessions with client business and IT teams - Perform system configuration testing, support code reviews, and manage merges - Support creation, execution, and defect resolution for User Acceptance Testing (UAT) and validation testing (IQ/OQ/PQ) - Prepare, review, and maintain GxP-compliant documentation, including functional specifications, configuration documents, and validation artifacts - Ensure solution design and delivery adhere to quality and regulatory requirements in regulated Life Sciences environments - Support project management activities including task tracking, status reporting, risk/issue management, and delivery coordination Qualifications: - Bachelor
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