Position Overview
This position will be part of the CAR-T Asset Management team within the Technical Operations group and will be responsible to support Commissioning and Qualification activities within the c GMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent (Belgium).This individual will be responsible for handling day-to-day administrator activities for both CAR-T Ghent facilities inclusive of managing users, extracting audit trails, periodic deleting of files, making back-ups on computerized GMP systems.This role will require a general GMP mindset and a strong ability to autonomously organize, execute and document administrative tasks to support business continuity.

Major Responsibilities

• Responsible for organizing and execution in the cleanrooms of day-to-day administrator activities on computerized systems inclusive of adding/removing users, extracting audit trails, execution of periodic deleting of files, making back-ups and corresponding documentation according to Good Documentation Practices
• Responsible for making run data exports to a centralized location upon operational request
• Keeping oversight of all user access requests and maintaining corresponding mailbox
• Keeping oversight on segregation of duties when following up on user access requests
• Following-up on archival of user access request forms
• Supports in paper and digital archival of executed C&Q documentation and tracks oversight
• Supports in collecting prerequisite documentation needed for execution of C&Q and periodic review activities

Qualifications
Education:

Graduate or Bachelor's Degree in Science, Engineering, Bioengineering or equivalent technical discipline is preferred
Experience:
A minimum of 1 year experience within a regulated environment is preferred.
Capabilities, Knowledge, and Skills:

• Proficient user of Microsoft Office applications (Word, Excel, Power Point, and Outlook)
• Right-first-time mindset is required
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously and balance competing priorities effectively
• Flexible mindset to guarantee business continuity
• Clear verbal and written communication skills
• Ability to pay attention to details and follow the procedures
• The candidate must be highly organized

Language(s):
Dutch, English