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
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
- qualifications
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.
