Quality Assurance Operations Specialist
il y a 2 semaines
**About the role**:
The QA Specialist a Fillingcts as Quality representative for quality/compliance related topics in relation with the Filling and Set-Up activities.
He/She supports the Compliance to cGMP’s, GDP’s and Takeda Procedures by defining and maintaining partnership between Quality and Operations.
He/She supports the adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures.
**How you will contribute**:
**To Quality systemoperations**:
- 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 a Quality Representative to review, approve and timely close Change Request according to applicable procedures.
- Act as a Quality Representative to review and approve maintenance corrective interventions (WO).
- Participate to Risk Assessment if requested.
- Represent the quality function in the approval of Document Change Request.
- Support of the Validation and Quality Validation departments for the execution of protocols in terms of improvement projects.
**To Quality Operation within your area of responsibility**:
- Support any quality decision in coordination with Manufacturing. Provide support and expertise in all quality related issues.
- Participate to the Observation Program.
- Participate to routine and project media fills in collaboration with the manufacturing department.
**What you bring to Takeda**:
- Master degree in Science (Biological, Chemical, Biochemical) or equivalent with experience
- 2 - 3 years with a general overview of Quality Systems
- Good level of reading/writing English
- Critical thinking, autonomy and problem Solving
- Good communication skills, asssertivity
- Organizational skills, focusing on priorities
- Collaboration and team player.
- Very good technical writing skills
**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 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._
**Locations**:
BEL - Lessines
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
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