Summary
About the Role
Role Title: Sr. Spec. DDIT Dev. BA TRD
Location: Hyderabad
Role Purpose:
Effectively transform the business requirements into an IT solution design specification, ultimately leading to meeting the customer expectations while assuring solutions are safe, reliable, scalable and flexible.
Act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis.
Roles and responsibilities:
• Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing as appropriate and ensure adherence to Security and Compliance policies and procedures within Service Delivery scope.
• Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
• Develop project rationale and perform prioritisation assessments to resolve feasibility of projects. Highlight/identify gaps in existing functionality and review requirements with stakeholders.
• Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to deploy solutions. Liaise with the service development team to suggest a high level functional solution.
• Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.). Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services.
• Ensure the overall user experience is considered when crafting and deploying new solutions and services. Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
• Ensure implemented solutions are according to specifications and fit for purpose.
• Support super user training.
• Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security)
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements :
Essential Requirements:
Education & Qualifications
• University degree in Informatics, Computer Sciences, Life Sciences or similar
Experience
• A minimum of 6+ years of experience in working in the Pharma or IT Industry
• Experience in the Lab IT domain
• Experience as a business analyst/process expert/ business IT lead superuser/Lab data or Digital position
• Good understanding of business process analysis & design and system architecture concepts.
• Understanding of the Lab business processes, drug development experience an advantage
• Knowledge of GXP, 21CFR Part 11 and the CSV lifecycle
• Knowledge of Lab systems including LIMS systems, Labware preferred and Chromatography systems, empower or chromeleon
• Prior working experience in TRD and knowledge on TRD business processes is preferred.
• Ability to solve complex business process / information challenges.
• Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
