Senior Quality Specialist - Bloemfontein, South Africa - Parexel

    Parexel
    Parexel Bloemfontein, South Africa

    2 weeks ago

    Default job background
    Local Office
    Description
    We are currently looking for an experienced Quality Specialists to be based in South Africa.

    Your time here

    At Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients

  • Manage the relationship with GDO Biostatistics and Statistical Programming
  • Provide Quality input to audits/inspections
  • Facilitate identification, investigation and remediation of Quality Issues (QIs) related to GDO Biostatistics and Statistical Programming activities
  • Facilitate the Risk Evaluation processKnowledge and Experience:


    • Knowledge of ICH-GCP and clinical trial regulation


    • Experience using root cause methodologies (5-whys, fishbone diagram, etc.)


    • English proficiency (written and oral)
    • Significant industry experience in one or more areas of PQRM support and / or Quality Management


    • IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices

    Skills:


    • Emerging ability to lead without explicit authority


    • Self-management: independent, takes initiative, proactive and organized


    • Focused on quality results - attention to detail and First Time Quality


    • Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback


    • Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned)


    • Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues


    • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge


    • Cultural awareness with the ability to think and work, globally


    • Ability to travel as needed for the position

    Education:


    • Bachelor's Degree or other relevant experience required. Life-science, health or industry-related discipline preferred

    •