Responsibilities:
• Manages and ensures proper functioning and GMP compliance of laboratory equipment.
• Coordinates vendor maintenance, calibration and validation services.
• Reviews vendor documentation for accuracy and completeness and completes associated work orders in the asset management system.
• Performs and documents equipment out of tolerance investigations.
• Ensures equipment information and vendor contracts are updated in the asset management system.
• Serves as point of contact for lab personnel and external vendors regarding equipment-related issues.
Required Skills:
• Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
• Experienced in GMP regulated drug development environment.
• Must possess a BS in molecular biology, biochemistry, or related field with at least three years of relevant experience.
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