Our client, a leading global pharmaceutical manufacturer requires an IT Business Analyst who has lead upgrades to IT systems, specifically for Quality and Supply Chain departments in a regulated environment.
Responsibilities Proven experience in managing stakeholders and demonstrates ability to navigate a complex business environment.
Deep understand of the current and developing IT Arena, specifically digitisation, cloud and cyber security.
Initial focus is to lead remediation & upgrade projects on legacy systems to bring in-line with current technologies.
Projects will be across QA, QC, Production Quality Systems and Supply Chain functions.
Other projects will cover migrations, New Technology introduction, Cyber Risks and Application risk analysis.
You will work with and be supported by other teams in the organisation including high level IT Architecture Team, Cyber Security, Technical Support etc.
Experience A Bachelor's Degree in Computer Science or STEM Majors (Science, Technology, Engineering and Math) or equivalent Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain Technical experience with Quality platforms such as, but not limited to LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower), Environmental Monitoring, Quality Management systems is Mandatory.
Expert understanding of analysis & design and system architecture concepts.
Expert knowledge of CSV lifecycle with understanding of Gx P (GLP/GCP/GMP), 21 CFR Part 11, EU Annex 11.
Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.
Expert understanding of the Lab business processes, drug development experience an advantage Ability to break down problems, build requirements for development tasks in an agile manner.
Skills: LIMS Chromatography Systems Quality management systems CSV