QA Operations Specialist - Filling

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Job Description

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.
• 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
• Min of 3 years experience of experience in a Pharmaceutical environment, with general overview of Quality Systems
• Critical thinking, autonomy, and problem-solving You offer the ability to think critically, work independently, and effectively solve problems.
• Effective communication skills You possess the skill to communicate clearly and persuasively in various settings, both in writing and verbally.
• Organizational skills with priority Focus You have exceptional organizational skills, with a special emphasis on prioritizing tasks and managing time efficiently.
• Team collaboration and teamwork You are adept at working collaboratively in teams, contributing to group efforts, and fostering a cooperative work environment.
• Flexibility and adaptability You are flexible and adaptable, capable of adjusting to new challenges and changing environments.
• Technical writing ability You bring strong technical writing skills, able to create detailed, clear, and concise technical documents.
• Assertive communication You demonstrate assertive communication skills, able to express ideas and concerns confidently and effectively.
• Flunet French and good English You bring a strong command of the English language, capable of both understanding complex texts and articulating ideas clearly in writing
  
  

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