Senior QA Qualification Engineer

Updated: April 11, 2024 08:32 AM GMT

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Stein

QA Qualification Manager

For one of our biggest client in Basel area we are looking for a QA manager, who will support the Project Team for their fill-finish aseptic facility project, and the incumbent will be responsible for the lyophilization line from DQ to OQ.

Key Responsibilities
• Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
• Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
• Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
• Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
• Providing leadership and guidance to project team members on C&Q strategy and issues
• Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
• Escalating issues in an open and... More Detail