Engineering Exception Coordinator

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Job Description

About the role:

Integrated in the Engineering Services and within the scope of Engineering – Maintenance – Metrology – Automation activities, the engineering exception coordinator leads investigations related to quality deviations. Together with technical experts and based on a structured analysis, the engineering exception coordinator identifies root causes to an event, evaluates the quality impact, writes an investigation report, coordinates the development and implementation of actions plans which are necessary to avoid reoccurrence. In its function of coordinator, he/she will treat the deviations in a timely manner and will establish an effective communication with the involved experts.

How you will contribute:

• Collects information relative to an event near the involved departments, performs structured investigations to identify root causes, evaluates the quality impact together with the quality department, analysis reoccurrence, identifies and assures implementation of effective action plans
• Writes investigation reports in a structured, rigorous and detailed manner (narrative style)
• Encodes all the information related to a deviation in the TrackWise system
• Coordinates the deviations with respect to targets
• Develops and maintains an effective communication with the expert departments (QO, Engineering, Maintenance, Metrology, Environmental Monitoring, Exception Management, Production)
• Presents critical deviations to the management
• Assures a supportive role during presentation of deviations in audits
• Is capable of creating digital improvement tools to facilitate the teams work

Technical/Functional (Line) Expertise

• Knowledge and understanding of manufacturing process and used technologies
• Knowledge of Quality requirements (USP, FDA, Eudralex)

Leadership

• Collaboration & teamwork during root cause investigations
• Good communication in order to achieve alignment on deviation approach between different implicated departments
• Motivate people in continuous improvement

Decision-making and Autonomy

• Critical Thinking
• Problem Solving methodologies (6M & DMAIC tools)
• Autonomy in deviation management

Interaction

• Regular interaction with QO, Engineering, Maintenance, Metrology, Environmental Monitoring, Exception Management, Production.

Innovation

• Demonstrate interest in used equipment and technologies
• Eager to learn
• Digital awareness

Complexity

• Demonstrate ability to handle different deviations of different topics and at different departments (Purification, Finishing, Utilities) at the same time.

What you bring to Takeda:

• Master in Engineering or Science or Quality
• At least 2-3 years of experience in a pharmaceutical environment
• Effective communication
• Organized, structured, rigorous
• Good writing skills
• Focus on the overall picture
• Skills in structured analyses (6M, 5 Why, FMEA, …)
• Excellent knowledge of MS Office
• Good French and English knowledge
• Stress resistant
• Knowledge of quality regulations (GMP, GDP, FDA, Eudralex)

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.

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.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. At Takeda, we embrace diversity as a whole.

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