QA Operations Specialist - FillingLessines, Wallonia
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
About the role:
As QA Specialist, you will act as Quality representative for quality/compliance-related topics in relation with the Filling and Set-Up activities.
You will support Compliance with cGMP’s, GDP’s and Takeda Procedures by defining and maintaining partnerships between Quality and Operations.
You will support the adequate deployment, implementation, and utilization of all quality systems as defined by Takeda Procedures.
How you will contribute:
To Quality system operations:
You will act as Quality Representative in the evaluation, investigation and approval of Deviation/EUME Reports.
Support 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:
Act as a quality link on the floor to support adequate quality systems deployment and application / Participate to TIER.
Support any quality decision in coordination with Manufacturing. Provide support and expertise in all quality related issues.
Perform GMP walkthroughs / observations during routine operations to ensure the application of the cGxP’s, the compliance to the procedures, and all the aspects linked to the safety, reliability and consistency of the operations.
Participate in the Observation Program.
Participate in 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
You have a critical thinking, autonomy and problem solving skills
Good communication skills, creativity.
Organizational skills, focusing on priorities.
Collaboration and team player.
Very good technical writing skills.
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.
LocationsBEL - Lessines
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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