Deviation Associate Specialist - Lessines, België - Takeda

    Takeda
    Takeda Lessines, België

    2 weken geleden

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    Description

    About the role :

    :

    Integrated in the Manufacturing Investigation Team and within the scope of manufacturing (Purification, Filling, Packaging, Engineering, Environmental Monitoring (EM)), the Deviation Associate Specialist leads investigations related to low to medium risk quality deviations. He/She will be responsible to investigate and document the investigations, identify root causes to an event, evaluate the quality impact, write an investigation report and coordinate the development and implementation of action plans necessary to avoid reoccurrence. He/she will treat the deviations in a timely manner and will establish an effective communication with the involved experts and customers.

    How you will contribute :

  • Performs structured and in-depth investigations to identify root causes, using the right investigation tools.
  • Evaluates the quality impact together with the quality department, analyses reoccurrence, identifies and assures implementation of robust action plans to ensure elimination of root causes.
  • Performs gemba's and engages with the right teams to invstigate the event thorougthly.
  • Writes investigation reports in a structured, rigorous and detailed manner (narrative style) and documents timely and correctly in Trackwise.
  • Is responsible to meet the sites' target KPI's.
  • Communicates effectively with the expert departments and customers (QA Ops, Engineering, Maintenance, Metrology, Environmental Monitoring, Exception Management, Manufacturing,...).
  • Is able to present problem statement, status of investigation and proposed CAPA in a clear, concise and autonomous manner at deviation boards.
  • Ensures a supportive role during presentation of deviations in audits.

    • What you bring to Takeda :

  • Master in Engineering or Science or equivalent by experience
  • Experience in pharmaceutical sector / GMP environment is a strong asset
  • Good knowledge and understanding of manufacturing processes and used technologies is a strong asset
  • Good level of investigation capabilities
  • Good (technical) writing skills
  • French: fluent
  • English knowledge: written basic to good, spoken basic.
  • Good knowledge of MS Office (Word, Excel, PowerPoint).
  • ERP system – JdE is an asset
  • Knowledge of structured analyses (6M, 5 Why, FMEA, DMAIC...) is an asset.

    • 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 :

    Locations

    BEL - Lessines

    Worker Type

    Employee

    Worker Sub-Type

    Fixed Term (Fixed Term)

    Time Type

    Full time