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Technical Business Analyst, DDIT Development, Research and Development
hace 2 meses
Key Responsibilities:
- Ensure consistency and traceability between business 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.
- Stay up-to-date 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.
- Develop project rationale and perform scoping assessments to determine 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 taken into account when designing and deploying new solutions and services.
- Ensure consistency and traceability between business 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.
Requirements:
- University degree in Business Administration, Computer Sciences, or related field.
- A minimum of 6+ years of experience in working in the Pharmaceutical or IT Industry, particularly experience in the Drug manufacturing IT domain.
- Experience as a business analyst/process expert/business IT lead superuser/manufacturing data or digital position.
- Good understanding of business process analysis & design and system architecture concepts.
- Ability to solve complex business process / information challenges.
- Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
- Understanding of the Pharmaceutical business processes, drug development experiences an advantage.
- Knowledge of Pharmaceutical systems including MES systems, and Historian systems is preferred. Knowledge of GXP, 21CFR Part 11 and the CSV lifecycle.
- Prior working experience in TRD and knowledge on TRD business processes is preferred.
Benefits:
As a valued member of 4050 Development LLC, you will enjoy a comprehensive benefits package, including a company pension plan, life and accidental insurance, meals, allowance or canteen in the office, and flexible working hours.
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.
