QA Officer Injectable Manufacturing

Jobinhalt

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 Technical Operations & QA team, we are looking for a high caliber, self-motivated, QA Officer Injectable Manufacturing based in Braine l’Alleud, Belgium

At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.

You Like To Work In An Environment Where

Together with appropriate management, you will be responsible for the implementation and maintenance of an effective Quality Management System on the UCB Braine Site to assure that:

• Local technical operations related to the manufacturing of injectable pharmaceutical products (DP) complies with applicable national and/or international regulations and guidelines (GMP) & relevant UCB Quality Policies.
• Marketed injectable pharmaceutical Products are manufactured and supplied in accordance with UCB Product Quality Standards.
• To pro-actively help operations identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements
  

You will ensure the following relevant QA tasks are timely performed:

• Participation to continuous improvement and product life cycle management
• Technology Transfer
• Process validation
• Equipment qualification
• Cleaning validation
• Stability studies
• Filing submission preparation and follow up of RA commitments
• Review/approval of Change control, Failure investigation, Deviations, CAPA plans
• Authoring and follow up of Product Quality Review
• Review and authorization of relevant SOP
• Provide support in the preparation and execution of internal / external audits.
• Assist Manager to achieve team objectives.
• Act as back up for other team QA Officers according to Manager instructions
  

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

Minimum of 3 years in a regulated pharmaceutical environment, including a minimum of 2 years experience in Quality Assurance (QMS & audit included) and/or. experience related to Sterile Manufacturing is needed.

Has demonstrate a fact-based decision-making process, process, accountability and delivering attitude

Knowledge of world-wide regulations pertaining to GMP and UCB Pharma policies and procedures

Excellent interpersonal relationship skills

Well developed sense of discretion and ethics

Excellent team player attitude

Fluent in English

Stress resistant

Independently identifying, communicate and initiate problem-solving process

Why you should apply

We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.

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 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.

Curious to know more? our website ucb.

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.