Beschreibung
Business Analyst - SDLC, GxP, CMDB, Pharma
Leading global pharma client require an IT Business Analyst with a background in Pharmaceuiticals, GxP, SDLC, CMDB etc.
Primary Tasks and Responsibilities
*Focus on improvements on the overall application landscape in alignment with the strategic and tactical guidelines
*Oversee and manage the application portfolio and roadmaps in alignment with line manager
*Maintain high level of quality, related to regulatory and compliance policies and guidelines
*Independent management and tracking of TLM related projects
*Define and maintain task and KPI driven reporting
*Support computerized system validation activities and understand the SD life cycle
*Understand and execute System Change Control following applicable policies and procedures
*Understanding of GxP/Regulatory requirements
Required Experience
*Advanced skills with personal productivity applications such as MS Word, MS Excel, flowcharting tools and Lifecycle Documentation
*Master and/or Bachelor Degree in Computer Science, Life Science OR equivalent through experience
*+3 Years of experience with projects in the pharmaceutical industry
*Ability to work in Matrix-organized organization/virtual teams
*Excellent communication skills in both German and English
*CMDB (configuration management database)
*Data Migration
*GAMP5
*GxP
*Life Sciences
*Project and/or Team Coordination
*Project Management Experience
*QMS (Quality Management System)
*SDLC
*Software Testing
Desirable Experience
*21 CFR 820
*21 CFR Part 11
*ISO 13485
Please apply now for more details!