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    Validations and Equipment Officer - Centurion, South Africa - Sentinel Staffing Services

    Sentinel Staffing Services
    Sentinel Staffing Services Centurion, South Africa

    4 days ago

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    Description
    Our client is a well-established medical group of companies in Irene, Centurion. They are looking for a Validations and Equipment Officer to join their dynamic team.

    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:
    • Writing and execution of validation protocols. This will Include but is not limited to: Process, Packaging, sterilization, and cleaning validations.
    • Conduct equipment qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
    • Download data logger files, monitoring trends, and generating reports.
    • Maintain temperature logger batteries.
    • Document and communicate the results and conclusions of validation plans.
    • Ensure the upkeep of master validation plans, monitoring validations, and initiating re-validation processes according to the master validation list.
    • Manage the equipment calibration schedule, ensuring timely calibration of all inspection, monitoring, and testing equipment.
    • Maintain an updated equipment list, adding newly qualified equipment as per protocol.
    • Execute environmental monitoring activities according to the quality schedule.
    • Arrange and send out quarterly product testing samples to external testing labs.
    • Perform periodic packaging verifications and facilitate aseptic process simulations.
    • Maintain comprehensive records of all activities in accordance with company procedures and standards.
    • Participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness.
    • Participate in audits and inspections as required.
    • Support day-to-day tasks related to maintaining Quality Management System (QMS) compliance as directed by the Head of Regulatory and Quality.

    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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