IT Validation Coordinator in Pharma

Company Description Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide.Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions.Focused on S4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake.Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality. Job Description We are seeking a detail-oriented and analytical IT Validation Coordinator to join our pharmaceutical team in Bengaluru, India. In this role, you will be responsible for coordinating and overseeing IT validation activities to ensure compliance with industry regulations and standards.Develop and implement IT validation strategies and plans for computer systems and equipment used in pharmaceutical processesCoordinate validation activities with cross-functional teams, including IT, Quality Assurance, and ManufacturingCreate and review validation documentation, including validation plans, protocols, and reportsEnsure compliance with FDA, EMA, and other relevant regulatory requirementsConduct risk assessments and gap analyses for IT systems and processesManage validation projects, timelines, and resources efficientlyCollaborate with vendors and internal stakeholders to resolve validation-related issuesStay up-to-date with industry trends and regulatory changes in IT validation and pharmaceutical complianceProvide training and guidance to team members on validation procedures and best practicesParticipate in audits and inspections related to IT systems and validation processes QualificationsBachelor's degree in Computer Science, Information Technology, or a related field3-5 years of experience in IT validation within the pharmaceutical industryStrong knowledge of IT validation methodologies and practicesProficiency in computer systems validation (CSV) and related documentationFamiliarity with pharmaceutical industry regulations, including FDA and EMA guidelinesUnderstanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)Excellent project management skills with the ability to manage multiple projects simultaneouslyStrong analytical and problem-solving skillsProficiency in Microsoft Office Suite and validation documentation toolsExcellent written and verbal communication skillsAbility to work effectively in a team environment and collaborate with cross-functional groupsDetail-oriented with a strong focus on accuracy and qualityCertifications in IT validation or pharmaceutical quality assurance (preferred)Experience coordinating validation activities for software systems and equipment in a pharmaceutical settingKnowledge of IT systems used in pharmaceutical manufacturing and research Additional Information At Fusion, we aspire to be one of the world's leading life sciences consulting firms, setting industry benchmarks with innovative and pioneering solutions.At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.Hiring Philosophy: We value employees who push boundaries through innovation, navigating diverse client needs in ever-evolving environments, with a commitment to continuous learning both for themselves and their colleagues.Growth & Development: Go beyond, grow beyond, and maximize impact. Each employee shapes their own journey, and our mission is to ignite the spark of greatness while pushing the boundaries of what you are capable of. We cultivate an environment where every individual can thrive and flourish through meaningful connections, extended learning, motivation, and support to experiment with new and innovative approaches, including taking risks.Feedback Culture: We emphasize and promote continuous, real-time feedback across all levels. We see feedback as providing individuals with the information and tools they need to develop their strengths and overcome challenges. Feedback is a gift, and inspiring individuals is our competitive advantageShape you own journey - How far will you take yourself?