IT Business Analyst, R&D required. An IT Business Analyst, R&D is required by one of Montash's clients, who are a leading FMCG company, in Southampton on an initial eight month contract (possibility for extension beyond).
Our client are seeking an IT Business Analyst (with experience in a regulated Pharmaceutical / Medical Device / Life Science environment) to work within the project team to support the definition, selection, design and implementation, migration and deployment activities of a new solution.
The IT Business Analyst, R&D will provide Business Analyst expertise to the Product Compliance, Consumer Product Safety, and Regulatory Intelligence groups, specifically supporting the project to implement a new Global Ingredients Management and Regulatory Reporting solution and understand business requirements & processes and identify business technology and/or process opportunities.
The IT Business Analyst, R&D will assist the business with updating of existing / developing new supporting procedures, and work with business leads to facilitate and define detailed Business Requirements, including: Capability Statements, Scope definition, Detailed Requirements, High Level as-is Business Process Maps, High Level to-be Business Process Maps, Information & Business Criticality assessments, Non-functional requirements (quality of service, architectural, security, legal, operational, performance, scalability and usability), support the system selection, design, configuration, testing and implementation processes and support the transition to a steady state and help the business in checking the 'end product' against the initial requirements.
- Experience of working in a highly regulated industry (Pharmaceutical / Medical Device / Life Science) in an IT/Technical Business Analyst role
- Strong understanding of GxP
Nice to have skills/experience:
- Awareness of the principles of risk-based Computer Systems Validation (GAMP5).
- Regulatory Reporting
- Product Lifecycle Management
- R&D environments
- Data Standards
- Document and/or Content Management
- Quality Management processes
If you are a good fit please apply immediately.