Make your mark for patients

To strengthen our QA Systems & Continuous Improvement department, we are looking for a talented profile to fill the position of: QA Systems Officer Utilities – Braine l’Alleud, Belgium

About the role

QA Systems Officer Utilities will ensure that all technical operations related to the production and analysis of pharmaceutical products comply with applicable regulations and guidelines (such as EMEA, FDA, PIC/S, ICH, and best practices defined by relevant organizations) as well as UCB Corporate Policies and Procedures, while also developing, implementing, and continuously improving robust and compliant systems and strategies that maintain and enhance operational and product quality in line with both regulatory and business requirements.

You will work with

You will be collaborating closely with the QA Systems & Continuous Improvement team, working in partnership with Braine Internal Manufacturing (BIM) and various supporting services. The role primarily involves providing support to Beltech Utilities operations and activities, which means regularly interacting with colleagues from manufacturing, quality assurance, technical services, and other departments involved in maintaining and improving the systems that support pharmaceutical production.

What you will do

General QA Role

• Ensure compliance with all relevant regulatory requirements and UCB requirements
• Organize adequate quality oversight on GMP documentation and activities
• Promote leading and proactive management of deviations, corrective and preventative actions, and change controls. 
• Actively participate to the quality governance in place within the organization
• Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the UCB QMS.
• Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections.
• Foster a culture of quality, compliance, and continuous improvement within the organization.

Beltech Utilities support

• Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval.
• Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the Braine site.
• Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
• QA follow-up of utilities/Beltech related projects and project management.
• Act as back-up for your direct colleagues or for your manager when needed

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

• Master's degree in a relevant field (e.g., Engineering, Science or a related discipline).
• Fluency in French and a good level in English are required
• Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
• Experience with Quality Management Systems and Auditing is a great asset
• Demonstrates outstanding writing proficiency and can compose clear, concise documentation.
• Skilled at handling several priorities simultaneously
• Demonstrates accountability by making decisions based on factual information
• Demonstrates the ability to independently identify issues and proactively implement solutions
• Collaborative team member with strong interpersonal and communication abilities
• Skilled at communicating clearly and effectively both verbally and in writing

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 [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.