Qualification Specialist

Make your mark for patients

We are looking for a Qualification Specialist who is eager to join us in our Qualification team, based in our biotechnological, pharmaceutical and chemical manufacturing site in Bulle, Switzerland.

About the role

As a Qualification Specialist, you will be responsible for ensuring the qualification of installations and systems in accordance with procedures, regulatory requirements, and user needs.

You will provide expertise in qualification during investigations, Change Controls, and projects, and present the qualification process and documentation during inspections and audits by health authorities and partners.

What you’ll do

• Ensure the correct qualification of GMP installations (including equipment, software, logic controllers and utilities).
• Write qualification plans, protocols and reports.
• Write and update the QMF (Qualification Master File) and PQR (Product Quality Review) documents.
• Participate to the continuous improvement of qualification documentation and processes.
• Participate in technical or organizational cross-functional projects as well as in specific manufacturing projects for activities related to qualification.
• Participate to deviations and Change Controls as SME for qualification related subjects.
• Present the qualification documentation during inspections and audits by health authorities and partners.

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

• Engineering or master’s degree in Life Sciences.
• In-depth knowledge of cGMPs and regulations linked with biotech/pharmaceutical manufacturing.
• More than 3 years in pharmaceutical and/or biotechnological manufacturing.
• More than 3 years in qualification of installations/systems.
• Work experience in controlled areas.
• High level of autonomy and proactivity.
• Excellent communication skills, with the ability to engage effectively at all levels of the organization.
• Teamwork.
• High level of autonomy and good stress management skills.
• Sense of responsibility and ownership.
• Sense of initiative.
• Strong problem-solving abilities.
• Capacity to prioritize effectively and make decisions.
• Good level of spoken and written French and English.

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 around 8,500 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 equitable 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.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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.