Qualification QA Specialist - Automation area

About the job

Make your mark for patients

We are looking for a Qualification QA Specialist – Automation area who is attentive to details and accuracy, team‑oriented, and analytical to join us in our eDI TS & Qualification team, based in our office in Bulle, Switzerland.

About the rôle

As an eDI TS & Qualification QA Specialist, you will oversee QA reviews for automation and manufacturing and lab equipment. You will act as the electronic data integrity expert, ensuring its implementation and compliance at the Bulle manufacturing site. You will also support QA oversight and contribute to improving the Quality Management System.

Who you’ll work with

You will report to the eDI TS & Qualification QA Manager and work within a team of five colleagues who foster a highly collaborative environment. You will also partner with cross‑functional teams, including QA, Qualification, and IT experts, to implement improvements and support new initiatives.

What you’ll do

• Review and approve automation and qualification deliverables for MES, DCS, and lab equipment
• Approve audit trails and access reviews according to GxP standards
• Perform review of SIP documentation
• Develop, implement, and maintain electronic data control processes and procedures
• Provide QA oversight for manufacturing and QC lab equipment compliance
• Support process simplification, continuous improvement, and new data integrity SOPs
• Monitor and report key performance indicators for data integrity control
• Define data flows and review critical data for QA integrity
• Participate in internal and external audits as required

Interested? For this role we’re looking for the following education, experience and skills

• 5+ years in pharma, with biopharma manufacturing and automation/CSV expertise
• Strong knowledge of MES/DCS qualification and lab equipment software
• Expérience with LIMS and Empower considered an advantage
• Ability to coordinate complex projects and meet critical deadlines
• Fluency in French and English with strong communication skills
• Strong GMP understanding, problem‑solving, negotiation, and proactive improvement mindset

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!

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on E-Mail schreiben. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.