• Support the adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures.
• Act as Quality Representative in the evaluation, the investigation and the approval of Deviation/EUME Reports, especially in Aseptic Filling subects.
• Supports timely closure of Deviation/EUME Reports according to applicable procedures.
• Act as a Quality Representative to review, approve and timely close Change Request according to applicable procedures.
• Act as a Quality Representative to review and approve maintenance corrective interventions (WO).
• Participate to Risk Assessment if requested
• Represent the quality function in the approval of Document Change Request.
• Support of the Validation and Quality Validation departments for the execution of protocols in terms of improvement projects
• Act as a quality link on the floor to support adequate quality systems deployment and application / Participate to TIER.
• Support any quality decision in coordination with Manufacturing. Provide support and expertise in all quality related issues.
• Perform GMP walkthroughs / observations during routine operations to ensure the application of the cGxP’s, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the
• operations (especially for Aseptic filling activities).
• Participate to the Observation Program.
• Participate to routine and project media fills in collaboration with the manufacturing department.
• Participate to continuous improvement projects (Yellow belt, DMAIC, GEMBA…).
• Provide support for internal and external audits
• Approve Deviation/EUME report to release lot or not
• Ensure Change Request Implementation and deployment in Compliance with cGxP’s.

What you bring to Takeda:

• Master degree in Science (Biological, Chemical, Biochemical, …) or equivalent with experience
• Min 3 years of experience in a Pharmaceutical environment, with general overview of Quality Systems
• Good level of reading/writing English
• Technical writing skills

What Takeda can offer you:

We want our employees to succeed in everything they do – at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.

We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

• Generous Time Off: 20 days of paid vacation in accordance with Belgian legislation and 12 Working Time Recovery days with additional days granted based on seniority and age.
• Health & Wellbeing: Comprehensive health and hospitalization insurance, annual check-ups starting at age 45, and support for preventive healthcare.
• Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
• Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
• Transportation & Eco-Benefits: Contributions for public transport, incentives for cycling, and on-site charging stations for electric vehicles.
• Additional Perks: Meal vouchers, eco-cheques, a flex plan, a 13th-month salary, and pension support.

Important Considerations:

At Takeda, our patients rely on us to create quality products, and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, hot environment and load manual handling.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals and biologicals products that may require specific protection (respiratory, skin, etc.).

More about us:

The Takeda Lessines manufacturing site plays a vital role in the production of Takeda’s plasma-based therapies. With over 75 years of pioneering legacy, Takeda is a global leader in rare diseases and ranks in the top three for plasma-derived products. Our Lessines manufacturing site is a state-of-the-art biotechnology production facility with over 50 years of experience, specializing in immunoglobulin purification, plasma-derived therapies, and packaging for treatments targeting blood disorders. Serving more than 250,000 patients worldwide, we are dedicated to delivering high-quality therapies that make a significant impact. As Takeda's third-largest global production site, Lessines plays a pivotal role in our international operations, producing and distributing million vials annually to more than 80 countries.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.