Quality Operations QA Specialist

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Quality Operations department, based in our manufacturing production site in Bulle, Switzerland, we are looking for a talented individual to fill the position of

Quality Operations QA Specialist.

As a Quality Operations QA Specialist, you will be responsible for compliance activities and quality strategies with regards to the operations related to products delivery, and responsible to proactively support operations (on the floor) in the biotech production area.

You like to work in an environment where you can:

• Provide quality support related to products delivery from start to finish for the product in charge, including management of activities and processes related to:
• Deviations, OOS, CAPAs,
• Change Control,
• Complaints,
• Equipment’s/Utilities/Environment qualification,
• Process/Cleaning validation,
• Product Quality Review,
• Continuous Process Verification,
• Master data activation,
• GxP documentation,
• Other activities as requested.
• Be responsible for compliance activities and quality strategies for projects with regards to technical operations related to manufacturing activities in the biotech production.
• Ensure through procedures that equipment/process are qualified/ validated according to current guidelines.
• Participate actively for external inspection/audits (before/during/after).
• Lead and/or participate to internal audits according to annual planning.
• Contribute to the redaction and/or approbation to SOPs, Methods, Specifications, Master Batch Record, etc.
• Actively contribute to Product Quality Reviews (PQR), Continuous Process Verification (CPV); and to investigations as needed.
• Perform Batch record review and Release/Reject activities as needed.
• Identify gaps, suggest and/or lead improvement initiatives.

Interested? For this position you’ll need the following education, experience and skills:

• Qualified to master’s degree level in life science (Biology or Chemistry), or Pharmacist.
• Proven QA work experience in quality control environment in biotech production.
• Ability to work closely with operational teams in manufacturing area.
• Demonstrated understanding of the GxP environment and technical competence in core areas of product manufacturing.
• Ability to coordinate multifaceted projects and to meet critical deadlines.
• Demonstrated ability to write up scientific/technical documents.
• Excellent negotiation and convincing skills.
• Demonstrated oral and written communication capabilities with varying, culturally diverse groups and/or individuals and/or functions.
• Excellent presentation and facilitation skills.
• Independent worker under tight and shifting priorities.
• Well-developed sense of discretion.
• Languages: Fluent in French & English (written and spoken).

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

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.