MSI Pharma are working with one of the top pharma companies in the world to hire a Quality Engineer for a 12 month contract.
Tasks & Responsibilities:
- Supports the Product Release Monitoring and Strategic Collaborator Employee Certification Program.
- Reviews and approves key quality records as they related to MD products in accordance to the Quality Agreement, such as:
- Nonconformance records (incl. CAPAs and Product Dispositions),
- Site Validation Master Plan and Validation protocols,
- Inspection plans and associated sampling strategies,
- Where necessary, collaborate in failure investigation and corrective action planning involving MD products.
- Coordinates MD review of nonconformance disposition in collaboration with other required MD functions ( Supports Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting MD products and coordinates additional subject matter expert support needed from MD.
- Initiates Stop Shipments and Product Issue Escalations for products out of MD control.
- Supports improvement plans to address below-target metrics and negative trends.
- Serves as the Source Quality Manager deputy.