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Columbia

    Commissioning and Qualification Lead - North Carolina, United States - i-Pharm GxP

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    Description

    Responsible for overseeing the commissioning and qualification of equipment, systems, and facilities to ensure they are installed correctly, function as intended, and meet regulatory requirements.

    The key responsibilities of a C&Q Lead include:

    • and executing commissioning and qualification strategies, protocols, and documentation for pharmaceutical manufacturing systems and equipment
    • design reviews, design qualifications, and overseeing the preparation, execution, and follow-up of qualification protocols
    • and reviewing a variety of technical documents such as user requirement specifications, functional requirement specifications, validation/verification master plans, and commissioning/qualification reports
    • multiple complex C&Q projects, providing status updates, and coordinating with cross-functional teams and external vendors
    • and leading technical and quality investigations related to commissioning and qualification activities
    • and executing remediation efforts and associated corrective and preventive action (CAPA) plans
    • adherence to cGMP regulations, FDA/EU guidance, and internal quality requirements
    • strong technical knowledge of equipment, instrumentation, automation, and facility systems within the life sciences industry
    • excellent project management, communication, and problem-solving skills to work independently and as part of a team

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