Senior QA Operational Associate - New Technologies応募後で応募 求人ID R0049393 掲載日 10/05/2021 Location:Lessines, Belgium
About the role:
Senior QA Operational Associate represent the quality function, especially for digital and new technology topics (automation, EBM, IT, data integrity). He/she acts as a Quality Representative to review and approve Change Request and manages the quality function in the approval and closing of Deviations.
How you will contribute:
- Represent the quality function specifically for digital and new technology topics (automation, EBM, IT, data integrity, etc.):
- Act as a Quality Representative to review and approve Change Request.
- Participate to FMEA if requested.
- Participate to requirements definitions for new technology (Electronic Batch Management, virtualization, Data management,
- Represent the quality function in the approval and closing of Deviations:
- Act as Quality Representative to evaluate, investigate and approve Deviation reports.
- Data and KPI analysis and creation.
- Act as a quality link on the floor to support adequate quality systems deployment and participate to TIER.
- Provide support in quality decision related to digital and new technology area.
- Perform GMP GEMBA 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.
- Participate to continuous improvement projects (Blue belt, DMAIC, etc.).
- Provide support for external audits
What you bring to Takeda:
- Master’s degree in technology (Chemical, digital, Automation …) or equivalent with experience
- 4 - 5 years with general overview of Quality Systems
- Quality mindset
- Knowledge of digital technology
- Data and trends analysis
- Good level of reading/writing English
- Able to understand pharmaceutical processes and requirements
- Schematic and methodic structure
- Critical thinking and problem-solving skills
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.