Deviation Associate Specialist
Lessines, WalloniaOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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Job Description
This is a wonderful opportunity to join the Manufacturing Investigation Team where you will be exposed to a multifaceted environment within manufacturing across; Purification, Filling, Packaging, Engineering, and Environmental Monitoring. As the Deviation Associate Specialist you will lead investigations related to a variety of risks. Responsible for investigating and detailing the root causes of an event, writing investigation reports, and coordinating the development and implementation of action plans necessary to avoid reoccurrence. Handle deviations promptly and establish effective communication with vital team members across the departments.
How you will contribute:
Performs structured and in-depth investigations to identify root causes, using the right investigation tools.
Evaluate the quality impact together with the quality department, analyze reoccurrence identifies and ensure implementation of robust action plans to ensure the elimination of root causes
Performs gemba’s and engages with the right teams to investigate the event thoroughly
Writes investigation reports in a structured, meticulous, and detailed manner and documents timely and accurately.
Responsible for meeting the sites’ target KPIs
Communicates efficiently with the expert departments and customers
Able to present problems, the status of the investigation, and proposed CAPA clearly and concisely at deviation boards
Ensures an encouraging role during the presentation of deviations in audits
What you bring to Takeda:
A university degree in Engineering or Science or equivalent by experience
Knowledge and understanding of manufacturing processes in a regulated environment to ensure we are aligned with Quality requirements (SOPs, USP, FDA, Eudralex and etc)
Good level of investigation capabilities by asking the right questions on deviation-related topics to clarify the source of the issue.
Awareness of statistical tools and methods and of how these are applied for investigational purposes (6M, 5 Why, FMEA, DMAIC…)
Supports continuous improvement initiatives
Good (technical) writing skill in English is needed.
Experience with multifaceted ERP systems – JdE, IQS requirements, and applications.
Stress resistance
On a personal level, you are open-minded, proactive, and eager to learn. An individual who shows curiosity and enjoys solvingproblems with a creative approach. More importantly, possesses excellent organizational skills, attention to detail, and the ability to collaborate effectively with a phenomenal interpersonal skills to communicate internally.
What Takeda can offer You:
We will make sure you get all the training and development opportunities you need to become the best in your field.
Health package: Hospitalization, outpatient, and group insurance
Financial planning and stability: Pension savings plan
Paid recovery days, restaurant tickets, eco-vouchers, and gift vouchers
Flexible benefits scheme
Possibility of free soft-skills training
A culture of inclusion and a workspace where everyone feels respected, valued, and free to be themselves
Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. 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, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
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.
Locations
BEL - LessinesWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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