Franz Stark

Communication of regulatory and in-house information Overseeing of documentation efforts to ensure compliance with regulations and standards. Developing and maintaining of SOPs and local working practices. Managing of audits and regulatory agency inspections. Training of staff in regulatory policies and procedures. Quality Representative within Project Teams. Handling, evaluation and approval within deviation management. Handling, evaluation and approval within change control management.

Quality support of licensed and development vaccines in consideration of regulatory requirements and applicable guidelines. Support of developmental product projects from quality perspective in consideration of regulatory requirements and applicable guidelines. Quality Product Owner and Quality Repr. within Project Teams. Preparation of product specifications, stability protocols and stability reports of licensed and development products.

Organisation and coordination of GMP relevant activities at pharmaceutical production (formulation and filling) plant LA24 (Lange Allee 24) Responsible for implementation and maintenance of QM-/GMP Systems. Responsible contact for QM-/GMP workflow and documentation. Document Owner and responsible for QM-/GLP relevant document creation and revision.

Molekularbiologie, Genetik, Krebsforschung, Zellbiologie, Biochemie, Physikalische Chemie, Chemie, Neurobiologie, Gefäßbiologie, Biologie, Immunologie, GMP/GLP, Englisch, Mathematik, Statistik, Projektmanagement

Datenverarbeitung, Programmieren (Programmiersprachen: VB, C, C++, Kobol, Java). Englisch, Regeltechnik, Datenbanken (Access, Oracle), Rechnungswesen, Betriebsorganisation, Mathematik