- You support deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs). You work in addition, on root cause analysis and development of corresponding corrective and preventive actions.
- You contribute to the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- You act as SME on internal and external audits and revise and approve SOP's and work instructions.
- You support the review metrics for identification of negative trends
- You act as deputy of the QA manager and you are a main point of contact for the Manufacturing process. This responsibility means you are able to take QA decisions autonomously related to GMP and quality compliance
- You will not immediately have a team to manage but in future this is likely. In this case you will manage and develop the Solothurn manufacturing quality team.
- You have in depth experience in quality manufacturing operations and this in a pharma or biotech environment. Ideally you have experience working with fully electronic operations and management.
- You have ideally team management experience as this will be in your future role scope
- You have good experience of process design and improvement.
- You have strong knowledge of GxP regulations
The Quality Assurance Manager, Upstream is responsible to ensure quality of the Bulk Drug Substance manufacturing processes in the Upstream area. You will take decisions related to manufacturing and production activities for quality assurance regarding cGMP, quality compliance, regulatory requirements, Quality Management System and the Change control system
In addition, with your knowledge you are able to work on continuous improvement projects related to Quality and Environmental Management Systems and Biogen products and processes. You ensure quality on the field supporting manufacturing with deviations and quality impact issues. You will contribute to the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
You will work cross-functional with different quality units, manufacturing sciences and Supply Chain focused on our Luterbach site but in collaboration with our colleagues working on the RTP site in the US.
You will report to the the Manager Quality Assurance.