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Job Description

About the role:

The QA Ops Shopfloor Filling Supervisor acts as Quality representative for quality/compliance related topics in relation with the Aseptic 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:

Quality System within his area of responsibility

• Act as Quality Representative in the evaluation, the investigation and the approval of Deviation/LI Reports, especially in Aseptic Filling subjects.

• Supports timely closure of Deviation/LI Reports according to applicable procedure.

• 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.
  

Quality Operation within his 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, the reliability and the consistency of the operations (especially for Aseptic filling activities).

• Participate to the Observation Program.

• Participate to routine and project media fills in collaboration with the manufacturing department.
  

Continuous improvement

• Participate to continuous improvement projects (Yellow belt, DMAIC, GEMBA…).
  

Compliance

• Provide support for internal and external audits.

What you bring to Takeda:

• Master degree in Science (Biological, Chemical, Biochemical, …) or equivalent with experience.

• Min 3 years of experience in a Pharmaceutical environment, with general overview of Quality Systems.

• 3 to 5 years in Pharmaceutical environment.

• Good level of reading/writing English.

• Critical thinking, autonomy and problem solving.

• Communication skills.

• Organizational skills, focusing on priorities.

• Collaboration and Teamwork.

• Flexibility.

• Techncal writing skills.

• Assertivity.

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.

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