Deviation Associate Specialist
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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.
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
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.
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
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.
