Review and QA approval of QA related documents and relevant CMC documents
Review of Batch Documentation (e.g. Master Batch Records, executed Batch Records) of Intermediates (Linker Payload, mAb), Bulk Drug Substance, Bulk Drug Product, Finished Product as applicable.
QA-Approval and follow-up Quality events from GMP relevant vendors (Deviations, OOX, Complaints, Quality Issues, CAPAs, Change Control).
QA release of Intermediates and Sponsor release of Investigational Medicinal Product (e.g. for USA)
Lead compilation of Product Specification Files in collaboration with the respective stakeholders as applicable.
Central QA point of contact at Tubulis for external GMP vendors and partners incl. setting-up, negotiating and revising Quality Assurance Agreements (QAA) with GMP vendors
First point of contact of (external) Qualified Person; compilation and provision of release relevant documentation Organization and/or conduct of audits of GMP relevant vendors incl. follow-up and audit closure
Organization and/or conduct of self-inspections/internal audits (e.g. Mock-Recall)
