Jobdescription
Location : Bulle, Switzerland
Activity rate : 100%
Type of contract : Temporary contract
Start date : 05.01.2026
Duration : 6 months (with possible extension)
As a QA Specialist joining UCB QA team, you will review and approve change management and qualification activities within a Biotech environment. You will assess the impact of changes on lab and manufacturing equipment and provide expert guidance on qualification risk strategies. You will also review key documentation for systems such as MES and DCS to ensure full compliance with QA standards. As a subject matter expert, you will help identify critical data assets and support robust QA methodologies.
Your key responsibilities :
* Review and approve changes in accordance with UCB processes
* Review and approve defined qualification deliverables such as URS, FRA, Testing evidence, defects, Qualification report, etc.
* Ensure through risk base approach the right qualification level ensuring compliance with regulation and UCB processes.
* Approve through procedures equipment's qualification reports according to current.
* Actively participate to quality strategies for projects.
* Coordinate relationships with internal / external customers / stakeholders including CMOs in order to provide efficient follow-up of product related deviations, change controls, investigations, incidents, etc.
Qualifikationen
What will make you successful :
* Minimum 5 years' experience in the pharmaceutical / biotech industry with strong expertise in qualification of laboratory and manufacturing equipment.
* Proven QA experience reviewing and approving qualification deliverables, with solid knowledge of MES, DCS, and automation.
* Strong understanding of GMP requirements and the ability to manage complex projects while meeting critical deadlines.
* Excellent communication skills in both French and English, with the ability to write SOPs and work instructions.
* Strong soft skills : discretion, negotiation, creativity, and proactive improvement mindset.
* Fast learner and trusted partner, able to propose quality-driven enhancements based on past experience.
#J-18808-Ljbffr