QA Ops Packing Specialist応募後で応募 求人ID R0060596 掲載日 02/22/2022 Location:Lessines, Belgium
How you will contribute:
- Represent the quality function, as specialist, in Deviations/EUME in his area of expertise (packing and visual inspection):
- Act as Quality Representative in the evaluation, the investigation and the approval of Deviation/EUME Reports.
- Supports timely closure of Deviation/EUME Reports according to applicable procedures.
- Act as Deviation/ CAPA owner when required
- Represent the quality function, as specialist, in the approval and closing of Change Control in his area of expertise (packing and visual inspection):
- Act as a Quality Representative to review, approve and timely close Change Request according to applicable procedures.
- Act as change control owner in the domain of expertise
- Act as a Quality Representative to review and approve maintenance corrective interventions (WO).
- Participate to FMEA if requested
- Represent the quality function in the approval of Document Change Request.
- Act as DCR owner in the domain of expertise.
- Act as a quality link on the floor to support adequate quality systems deployment and application
- Participate to TIER.
- Participate, as quality representative, to the organization of rework activities.
- Support any quality decision on the floor in coordination with Manufacturing. Provide support and expertise in all quality-related issues in his field of expertise (packing, visual inspection)
- 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 (Yellow belt, DMAIC, …).
- Provide support for external audits.
Approve Deviations/EUME reports with decision to release lots or not
- Ensure change request implementation and deployment in Compliance with cGxP's and risk based approach
25% Change Control/Projects
15% Continuous improvement
10% On the floor
10% QO protocol
What you bring to Takeda:
- Master degree in Science (Biological, Chemical, Biochemical, …) or equivalent with experience
- 3- 5 years with general overview of Quality Systems in GMP and manufacturing environment
- Good level of reading/writing English
- Critical thinking and problem Solving
- Stress resistant
- Good communication
- Focus on priority
- Organizational skills
- Collaboration and Teamwork
- Personal Attributes
- Customer focus
- Integrity and trust
- Intellectual Honesty
- Shared Values
- Accountability and Integrity
- Dedication to Quality
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.