QA Operation Filling Sr Specialist

☞ Takeda

View: 180

Update day: 26-11-2025

Location: Lessines Hainaut

Category: Quality Assurance / Quality Control

Industry: Financial Services Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

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Job Description

Quality Operation within his area of responsibility:
  • Represent quality in significant quality-related issues, provide support and expertise. Understanding technical/production complex problems and evaluating potential impact on product quality
  • Perform GMP walkthroughs/Gemba 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.
  • Support any quality decision on the floor in coordination with Manufacturing.
  • Participate to the Observation Program
  • Participate to routine and project media fills in collaboration with the manufacturing department.
  • Participate in the definition of the quality requirements for projects related to e.g. process/facility/Equipment modification
Quality System Within His Area Of Responsibility
  • Act as quality representative in the evaluation, the implementation and the approval of change control
  • Act as Quality Representative in the evaluation (risk evaluation, mitigations, lots potentially impacted and to be held from release), the investigation (including quality impact) and the approval of deviation Reports
Continuous improvement
  • Lead, support and/or participate to continuous improvement initiatives
  • Act as a Yellow Belt coach for projects within the department
  • Support all global initiatives related to quality related topics for the area of responsibility
  • Provide expertise during the revision of Global procedures and guidance
Compliance
  • Participate in external inspections.
  • Provide support if necessary to the Regulatory team by providing required data for submission files
Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Deadline: 10-01-2026

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