Job Properties
  • Job Type
    Full-time Position
  • Category
    Marketing, Communication & Advertising
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Hoofddorp
    • Date Posted
      September 06,2022
    • IMG_6430
    • VISA
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    QA Documentation Lead

    Job Description

    QA Documentation Lead

    Kite, a Gilead Company

    At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

    Your responsibilities

    • Supervising QA Documentation personnel including organizing and prioritizing workflow and daily tasks
    • Ensuring timely distribution of controlled issued documentation to operational departments.
    • Writing and revising standard operating procedures (SOPs) and work instructions for continuous improvement of systems.
    • Ensuring quality of on-the-job trainings and provides hands-on day-to-day guidance to the personnel
    • Ensuring inventory of operational materials are maintained
    • Maintaining/presenting monthly document control metrics.
    • Identifying areas for improvements and working on implementation after alignment.
    • Providing additional support and assistance on tasks and projects with minimal direction from management.
    • Providing oversight of staff performing activities in support of document control.
    • Providing input for performance evaluations.
    • Providing support to internal and regulatory audits/inspections as required.
    • Creating, maintaining, and contributing to continuous improvement of document issuance operation.
    • Ensuring deviation investigations are completed timely and right corrective actions are defined and implemented.
    • Additional duties as assigned.

    Skill requirements

    • Demonstrating advanced technical knowledge in industry practices.
    • Demonstrating advanced knowledge of computer systems which support document control processes.
    • Demonstrating the ability to clearly and concisely present/ explain documentation requirements and deviations to multiple internal audiences.
    • Demonstrating an ability and desiring to supervise and support staff.
    • Demonstrating good coping skills and analytical problem-solving skills.

    • 5+ years in GMP as QA
    • 2+ years team management experience

     
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