The position will require difficult decision making and management of critical situations to have significant impact for the company. The team is working in commercialisation of new products within the global Biologics function.
What you will do:
* Act as Qualified Person (Sachkundige Person) according to ยง 19 AMG and Annex ยง16 AMWHV with the responsibility to assure that globally every bulk batch/batch of biologic products has been manufactured, packaged, and tested in full compliance with the GMP requirements of the local Regulatory Authority and with the specifications in the Marketing Authorisation of the importing country/product specifications
* Ensure compliant and timely release preparation of Biologics Drug Substances, Bulk Drug, PFS and Vial in order to ensure product supply
* Cooperate/support/lead cross functional projects in terms of product transfer and compliance initiatives
* Plan and compile Product Quality Reviews for Biologic Products
* Act as Quality Manager according to Site Master File
* Support the Trend Monitoring for Biologics Germany
* Act as member in global CMC teams
* Manage BPDR /DPR's and risk evaluations of high impact market complaints
Key responsibilities:
* We are looking for the right talent for this role. Whether you are a Natural Scientist or Engineer, e.g. pharmacist, degree in biotechnology or if you are already qualified as QP or come with even higher qualification. You are the perfect candidate if you have the right mindset and attitude
* Analytical thinker with hands-on mindset combined with a global view and ability to define practical solutions
* Ideally 5 years in production or technical support roles like QA and/or Quality Systems
* Solid understanding on QA, QC and Quality Systems with solid knowledge of GMP, experienced in regulatory inspections
* Team player with excellent communication skills
* Experienced in project management skills including definition of resolution.
* Fluent in English and German, both spoken and written
