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Quality Electronic Data Integrity Specialist

vor 3 Monaten


Bulle, Schweiz Randstad Vollzeit

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:

â¢Responsible to perform electronical data review on required lab and manufacturing equipment;
â¢Perform electronic data integrity (e-DI) check on laboratory results
â¢Enforce Compliance of stakeholders on e-DI process with relevant GxP standards understanding the challenges;
â¢Act as QA on CSV, Equipment Qualification discussion to ensure e-DI compliance;
â¢Actively participate to quality strategies for projects in the area of responsibilities (as assigned).
â¢Write SOPs according to current QMS

qualifications

Your profile:

â¢Diploma in Life Sciences with a solid experience of 5 years;
â¢Solid knowledge of lab equipments, specially LIMS and Empower software;
â¢Expert on CSV and equipment qualification on GMP regulation
â¢Ability to coordinate multifaceted projects and to meet/respect critical deadlines;
â¢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.