Sterility Assurance Sr Specialist

☞ Takeda

Ver: 170

Día de actualización: 26-11-2025

Ubicación: Lessines Hainaut

Categoría: Contabilidad / Auditoría Finanzas / Banco / Acciones

Industria: Financial Services Biotechnology Pharmaceuticals

Posición: Entry level

Tipo de empleo: Full-time

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Contenido de trabajo

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Job Description
  • Provide support and expertise in sterility assurance issues and aseptic practices.
  • Participate to Global calls related to sterility assurance.
  • Documentation: Ensure that procedures related to sterility assurance are in compliance with Divisional Procedures, License requirements and Regulatory guidelines/requirements.
  • Approve and review protocol and report in relation with sterilization, aseptic process, media dill, smoke test or gamma irradiation.
  • Help to define, implement and maintain current the Qualification Programs to assure that all systems & processes are in an accurate qualified state:
    • Depyrogenation / Steam sterilization processes;
    • SIP systems;
    • Sterilization of the lyophilizers;
    • Media fills;
    • Gamma sterilization;
    • VHP cycle of the isolator
  • Approve Qualification Studies, e.g.
    • Smoke test;
    • Media fill;
    • Heat distribution/penetration studies;
    • Biological Indicators results;
    • Endotoxin Indicators results;
    • Gamma sterilization requalification.
  • Provide support in the development and deployment of training (including Gloves visual inspection certification).
  • Supports any process/facility/Equipment modification (including Cleaning process) by participating to the Sterility Assurance requirements definition for related projects.
  • Responsibility for Quality Systems:
    • Deviation and Change Control Management: Provide support and write assessment in case of change control or deviation that should have an impact to sterility or aseptic process.
  • Participate to the Aseptic practices Observation Program.
  • Participate to Media-Fill and smoke tests.
  • Compliance: Participate actively in internal and external audits. Contact with the Regulatory Agencies during audits.
  • Give support and review regulatory submission when needed
Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Plazo: 10-01-2026

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