Validation Officer - Jeddah, المملكة العربية السعودية - Med City Pharma

    Med City Pharma
    Med City Pharma Jeddah, المملكة العربية السعودية

    منذ أسبوعين

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    دوام كامل
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    Job Summary

    Responsible for ensuring equipment is suitable for its intended use through analyzing, inspecting, calibrating, testing, developing and executing of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation.

    Main Tasks & Responsibilities

    • Participate in Developing and executing validation plans for new facilities, processes, equipment, and systems.
    • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment.
    • Test the proper functioning of equipment and resolving any issues, including making adjustments or improvements.
    • Maintain the correct calibration and other parameters of instrumentation and equipment.
    • Ensure that equipment meets design specifications and regulatory requirements.
    • Develop and execute process validation protocols, including process characterization, process performance qualification (PPQ), and ongoing process verification.
    • Establish and validate cleaning procedures in cooperation with the manufacturing teams.
    • Implement cleaning validation protocols to ensure that cleaning procedures effectively remove product residues and contaminants.
    • Document test results, analyze data, and report on the validation status, identifying any deviations or issues.
    • Create databases and validation schedules to track validation activities/ maintain accurate and up-to-date records.
    • Ensure compliance with data integrity requirements.
    • Manage change control processes related to validated systems and processes.

    Job Requirements and Skills

    • Bachelor's degree in mechanical or electrical engineering.
    • Minimum one year of experience in validation activities within the pharmaceutical industry.
    • Strong understanding of manufacturing processes and safety regulations.
    • Knowledge of regulatory requirements, including SFDA and other global regulatory agencies.
    • Strong analytical and problem-solving skills.
    • Attention to detail and ability to work independently and collaboratively.