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Centurion

    QA and Regulatory Officer - Centurion, South Africa - Sentinel Staffing Services

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    Description
    Qualifications:
    Tertiary degree required in the Natural Sciences or Engineering
    Minimum of 2 Years working experience

    Competencies:
    • Good communication skills in writing, presentation, and interpersonal communication (Good writing skills is essential)
    • High ethical standards
    • Good understanding of statistics
    • Computer literate: Microsoft Office

    Primary Responsibilities:
    • Develop validation protocols and reports encompassing process, packaging, sterilization, and equipment validations, ensuring compliance.
    • Maintain document control for all materials used in the quality management system.
    • Conduct quality reviews of documentation, including procedures, forms, and records.
    • Coordinate the resolution of non-conformances by collaborating with relevant departments, documenting processes, and ensuring evidence inclusion.
    • Oversee process risk management and document all preventive actions as required.
    • Conduct internal audits within the department.
    • Assist in facilitating third-party audits as instructed by the department manager.
    • Assist in organizing supplier audits as directed by the department manager.
    • Identify areas for enhancing the quality management system and facilitate necessary actions.
    • Provide regulatory support for product development, including assisting in technical documentation and clinical evaluations.
    • Deliver and coordinate training on quality processes and procedures for staff.
    • Support day-to-day tasks associated with maintaining QMS compliance.

    Working hours are Mondays to Fridays from 07:00 to 16:00 (With overtime on demand)
    The role is available to start as soon as possible, preferably by 1 June 2024
    .

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