Equipment & Data Integrity Associate
Role details
Job location
Tech stack
Job description
Join UCB as an Equipment & Data Integrity Associate in Bulle, Switzerland. Make your mark for patients with a team driven by science.
Tasks
- Ensure data integrity and manage computerized systems in QC.
- Participate in laboratory equipment installation and validation projects.
- Assist in audits while collaborating with teams in Belgium., To strengthen our Computerized Systems and Equipment team within the Patient Supply Quality Control department, we are recruiting an Equipment & Data Integrity Associate for our Bulle campus, Switzerland.
As an Equipment & Data Integrity Associate, you ensure all aspects of digitization and data integrity of the equipment and computerized systems of the Patient Supply Quality Control department, whether for the operational use of laboratory equipment, new equipment projects, or electronic transformation projects of laboratory processes.
You will join a dynamic and motivated team composed of several experts interacting with the Quality Control, IT, Qualification, and Quality Assurance departments. This team is spread across the Bulle site and Braine L'Alleud in Belgium.
Your main tasks will be to:
- Participate, as a data integrity expert, in projects and validation of "standalone" computerized systems in collaboration with the Business project manager, qualification/validation teams, metrology/maintenance, quality assurance, and IT.
- Within the framework of new laboratory equipment installation projects:
- Perform risk assessments related to data integrity (DIRA) and make recommendations for resolution and mitigation of potential vulnerabilities.
- Ensure the security of raw data by proposing appropriate backup measures.
- Create the system administration document and define the security levels and types of roles/functions to be implemented.
- Define the access management process.
- Execute, in partnership with colleagues, the "annual review" program of computerized equipment in the QC laboratories of the Bulle campus.
- Manage incidents related to laboratory equipment problems concerning data backup issues and system access problems. Act as first-line support.
- Work integrally with the Belgium team.
- Participate in preparation and support activities during audit and inspection periods.
Requirements
- Experience in quality control labs and knowledge of data compliance.
- Proactive problem-solving and strong feedback abilities.
- Ability to work autonomously and adapt to changing priorities., Interested? For this position, you must have the following education, experience, and skills:
- Proven experience working in a quality control laboratory and knowledge of various computerized analytical equipment and their parameterization and configuration (security, access control, data protection).
- Knowledge and understanding of compliance and data integrity aspects and requirements in the context of analytical laboratory activities in a Bio-Pharma environment.
- Ability to give and receive feedback.
- Work with a continuous improvement mindset and proactively propose solutions to increase the department's process efficiency day by day.
- Demonstrate flexibility in managing priorities.
- Work with maximum autonomy.
- Be proactive towards clients or colleagues to constructively and effectively solve any problem.
- Practical experience in audit and compliance inspection contexts is a plus., Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!