Quality Engineer
Updated: April 10, 2024 03:28 AM GMT
PharmiWeb.jobs: Global Life Science Jobs
SteinWe are seeking a Quality Engineer for a CAPEX project, aimed at supporting the Project Team in ensuring operational readiness for a fill-finish aseptic line project.
Primary Responsibilities
• Overseeing quality and regulatory aspects of the assigned CAPEX project
• Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility throughout the project lifecycle, from design engineering to initial C&Q and handover phases
• Reviewing and approving C&Q documents for GMP systems, as well as associated changes and deviations
• Supporting audits and regulatory inspections
• Providing leadership and guidance to project team members regarding C&Q strategy and issues
• Ensuring decisions are supported by both global and local Quality, as well as Regulatory
• Promptly escalating issues and taking leadership in their resolution
Key Requirements
• Bachelor's or Master's degree in Engineering, Life Sciences, or a related field
• Extensive experience in the GMP regulated... More Detail
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