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Job Description

About the role:

As a QA Ops Shopfloor Filling Supervisor, you will ensure Quality on the Shopfloor oversight of Aseptic Filling and Set-up activities for the site. You will manage a team of around 10 employees working in 5 shifts (24h/7d).

How you will contribute :

• Support the Compliance to cGMP’s, GDP’s and Takeda Procedures by defining and maintaining partnership between Quality and Operations internal teams
• Support the adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures
• This role includes rapid decision-making on critical and complex subjects, with direct product impact, to ensure the Quality of Aseptic Filling and Set-up operations
• Manage and develop resources, ensuring their training and qualification
• Supervise and efficiently allocate resources while conducting development plans and regular performance reviews in alignment with department goals
• Act as the operational back-up for the QA Ops Filling Manager
• Maintain and adjust the department’s KPIs
• Act as a quality link on the floor to support adequate quality decisions in collaboration with Manufacturing and Maintenance
• Manage stakeholders during key interactions related to all quality-related issues
• Supervise the review and finalization of critical records (batch records, critical data) to meet regulatory deadlines
• Provide support in performing complaint or adverse event investigations, as needed
• Develop and Perform GMP walkthroughs during routine operations to ensure the application of the cGMP’s, GDP’s, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the operations.
• Take part in the critical evaluation and resolution of deviations, out-of-specification results, and CAPAs with a proactive risk management approach
• Collaborate in continuous improvement processes, including cross-functional projects (DMAIC, Kaizen, etc.) and benchmarking with other Takeda sites
• Provide support in the development and deployment of training (including Gloves visual inspection certification)
• Supervise the requalification of critical equipment (sterilization, depyro, smoke tests, Emeri tests…) and the execution of media fills in collaboration with production
• Follow-up schedule and Manage the routine media fills Quality participation in collaboration with the manufacturing department
• Actively participate in projects related to new equipment or processes while ensuring compliance with regulations and best practices
• Documentation: Continuous improvement of documents in direct partnership with production. Supervise the documentation changes review by Quality
• Compliance: Participate in the internal/external audit program

What you bring to Takeda:

• Degree in engineering/technical sciences, chemistry, biotechnology, or equivalent, with 4-5 years of relevant experience in a GMP environment, ideally in aseptic filling of biological products
• Solid experience in team management with demonstrated leadership and communication skills
• Good English level, both written and spoken, to ensure effective communication in an international and regulated environment  
• Expertise in Quality systems, manufacturing processes, and FDA/European regulations
• Strong communication capabilities at all organizational levels, including with managerial stakeholders
• Team management and leadership, emphasizing performance and development

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.

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