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 processes
• Coordinate validation activities with cross-functional teams, including IT, Quality Assurance, and Manufacturing
• Create and review validation documentation, including validation plans, protocols, and reports
• Ensure compliance with FDA, EMA, and other relevant regulatory requirements
• Conduct risk assessments and gap analyses for IT systems and processes
• Manage validation projects, timelines, and resources efficiently
• Collaborate with vendors and internal stakeholders to resolve validation-related issues
• Stay up-to-date with industry trends and regulatory changes in IT validation and pharmaceutical compliance
• Provide training and guidance to team members on validation procedures and best practices
• Participate in audits and inspections related to IT systems and validation processes

Qualifications

• Bachelor's degree in Computer Science, Information Technology, or a related field
• 3-5 years of experience in IT validation within the pharmaceutical industry
• Strong knowledge of IT validation methodologies and practices
• Proficiency in computer systems validation (CSV) and related documentation
• Familiarity with pharmaceutical industry regulations, including FDA and EMA guidelines
• Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• Excellent project management skills with the ability to manage multiple projects simultaneously
• Strong analytical and problem-solving skills
• Proficiency in Microsoft Office Suite and validation documentation tools
• Excellent written and verbal communication skills
• Ability to work effectively in a team environment and collaborate with cross-functional groups
• Detail-oriented with a strong focus on accuracy and quality
• Certifications in IT validation or pharmaceutical quality assurance (preferred)
• Experience coordinating validation activities for software systems and equipment in a pharmaceutical setting
• Knowledge 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 advantage

Shape you own journey - How far will you take yourself?