Requirements: English
Company: WhatJobs
Region: Lessines , Wallonia
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Job Description
About the Role:
As the QA Ops Specialist- Packing Support & Warehouse, you will represent the quality function, as specialist, in Deviations/EUME in his area of expertise (warehouse, R&I, supplier, disposition, packing and visual inspection). You will act as Quality Representative in the evaluation, the investigation and the approval of Deviation/EUME Reports. You will support timely closure of Deviation/EUME Reports according to applicable procedures and act as Deviation/ CAPA owner when required
How you will contribute:
- Represent the quality function, as specialist, in the approval and closing of Change Control in his area of expertise (warehouse, R&I, supplier, disposition, 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 reprocessing 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 cGxPs, 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
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 probem Solving
- Autonomy
- Stress resistant
- Good communication
- Focus on priority
- Organizational skills
- Collaboration and Teamwork
What Takeda can offer you:
- 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 trainings
- 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.
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 Brigh