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Let's push the boundaries together and make the most of your talents!

QA Expert Quality Management Systems

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  64894

 

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

To strengthen our Global Manufacturing & Engineering team, based in our hub in Braine-L’Alleud, Belgium, we are looking to fill the position of: Quality Systems Officer - Quality Management Systems.

 

Do you see yourself as a pragmatic person who maintains ethical ways? UCB believes you to be a ‘pragmathical’ person. This very special blend of talent means you are using your heart and your mind to help patients live a fuller life.

 

As a UCB 'pragmathical' person and Quality Systems Officer - Quality Management Systems you like to work in an environment where you can:

 

Assure that all technical operations related to the production & analysis of pharmaceutical products comply with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICHI best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures (co-)develop and (co-)implement technically robust and compliant systems.

This will allow to exploit, maintain, monitor and continuously improve operations develop and implement strategies that will assure the establishment and maintenance of a State of Compliance and a State of Control pro-actively identify, develop and implement quality improvements in response to business requirements, technical changes and regulatory requirements drive continuous improvement projects that will allow risk reduction, improved Quality KPI and product quality.

 

 

As a UCB 'pragmathical' person and Quality Systems Officer - Quality Management Systems you will contribute by:

 

Organizing and coordinating the preparation and the hosting of external audits, hereby acting as a major liaison for the auditors

Coordinating with appropriate management the composition of the response package to the external audit observations, ensuring timely response and assure execution of defined CAPAs and engagements

• Planning, assuring execution and follow-up of internal audits

Leading or co-leading internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to GMP

• Promoting Quality and Operational Excellence and cultivate "Quality Culture", "Compliance Awareness", "Continuous Improvement Attitude" & "Accountability Culture" across the UCB teams

• Driving Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements

• Implementing and maintaining adequate Quality & Compliance Indicators and communicating results to appropriate levels of the organization

• Implementing and maintaining an adequate QS Cockpit and communicating results to appropriate levels of the organization

Supporting the Site Facilities department in all their GMP related activities and, where appropriate, develop and implement technically robust and compliant Processes & Systems

• Supporting the Site Facilities department & relevant BTO & BPS Management to develop, implementing and maintaining a compliant Pest Control System and assuring quality reporting hereof

• Ensuring the Supplier Qualification, according to UCB requirements and existing systems

• Ensuring continued compliance of the QMS to applicable regulations and guidelines, UCB Corporate Policies & Procedures, UCB objectives, plans and projects

• Driving quality leadership and technical expertise on Quality Management System compliance strategy and interacting with other functional areas to effectively communicate Quality Management System requirements

Supporting Global QA & (Senior) Management in establishing, implementing, maintaining and ensuring continuous improvement of an effective and efficient Quality Management System (serving both local & global needs)

• Maintaining and continuously improving the Quality Management System and related processes

• Developing, driving and/or implementing quality improvement and operational excellence projects in response to business requirements, observed issues, technical changes, identified risks, audit observations and changing regulatory requirements

• Acting as back-up for his direct colleagues according to the Team Leader's instructions and after appropriate training

 

 

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

 

Master’s Degree or equivalent by experience

Experience in a regulated pharmaceutical environment or other life science or health related field, including experience in Quality Assurance

Experience with Quality Management System and Internal / External Auditing

Eager to learn & grow in the position

High potential with affinity for Quality & Compliance and worldide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices

Ability to balance multiple priorities

On-time delivering attitude

Team player with good interpersonal relationship and communication skills

Very good oral and written communication skills

Capable of independently identifying problem situations and initiating problem solving process

Ability to influence by persuasion

Stress resistant

Fluent in French and in English

Well developed sense of discretion

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers


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