QA Ops Packing Sr Specialist

☞ Takeda

看过: 215

更新日: 26-11-2025

位置: Lessines Hainaut

类别: 质量保证/质量控制

行业: Financial Services Biotechnology Pharmaceuticals

水平: Associate

工作类型: Full-time

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工作内容

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Job Description

The purpose of this job is to act as quality expert for quality/compliance related topics in relation with the Packaging, Visual inspection and Labelling operations.

The function will also support CI and digital initiatives through the Packaging, Visual inspection and Labelling department.

Your Accountabilities

Quality Operation within his area of responsibility (Packaging and Labelling):
  • Assure the correct deployment of the cGMP, Takeda guidance within the quality operations department
  • Represent quality in significant quality-related issues, provide support and expertise. Understanding technical/production complex problems and evaluating potential impact on product quality
  • Participate in the definition of the quality requirements for projects related to e.g. process/facility/Equipment modification
  • Support any quality decision on the floor in coordination with Manufacturing.
  • Review data trending in QA perspective within his frame of responsibility ( for example Visual inspection meeting monitoring)
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/Digital
  • Lead, support and/or participate to continuous improvement initiatives
  • Act as a Yellow Belt coach for projects within the department
  • Lead and/or support digital initiatives
  • Support all global initiatives related to quality related topics for the area of responsibility
  • Provide expertise during the revision of Global procedures and guidances
Compliance
  • Participate in external inspections.
  • Provide support if necessary to the Regulatory team by providing required data for submission files
Your Profile

Master degree in Sciences (Chemist, Bioingeneer, Bio statiticien, Pharmacist, …)

5-10years Experience in GMP environment and manufacturing environment

Excellent IT and digital system knowledge/capability

Critical thinking, stress resistant, autonomy,

Ability to summaries information, technical writing skills,

strong communication skills,

knowledge in risk management regulation, data analytics skills

ability to work in a matrix organization

Driven by operational excellence and digital solutions

Focusing on priorities, handle multiple topics simultaneously in a high-volume environment, while meeting deadlines and attention to details

Ability to work effectively with all levels of management and resolve problems in a timely manner

French and English (written and spoken – advanced level) – manadatory

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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最后期限: 10-01-2026

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