Quality Electronic Data Integrity Specialist (H/F)
You are passionate by Human Health and need the urge to thrive for a patient value. We need you in that case for a long term temporary position up to end of august 2025.
A short resume of the function would be:
Maintain, develop, and collaborate within the organization 'electronic data integrity QA 'team within the organization ?HSE & Quality Culture & Compliance' in alignment with the site vision, mission, long term plan, and UCB Values to deploy HSE & Quality Culture within Bulle site;
Your mission:
*Responsible to perform electronical data review on required lab and manufacturing equipment;
*Perform electronic data integrity (e-DI) check on laboratory results
*Enforce Compliance of stakeholders on e-DI process with relevant GxP standards understanding the challenges;
*Act as QA on CSV, Equipment Qualification discussion to ensure e-DI compliance;
*Actively participate to quality strategies for projects in the area of responsibilities (as assigned).
*Write SOPs according to current QMS
Your profile:
*Diploma in Life Sciences with a solid experience of 5 years;
*Solid knowledge of lab equipments, specially LIMS and Empower software;
*Expert on CSV and equipment qualification on GMP regulation
*Ability to coordinate multifaceted projects and to meet/respect critical deadlines;
*Fluent in both French and English (Oral and written).
we can offer you a new challenge in a diverse and innovative environment. Have we sparked your interest? Then we look forward to receiving your online application.
