Contribution to the Continuous Improvement of the Corporate Midas Pharmaceutical Quality System.
Management of international GxP and Regulatory standards during sourcing, development, procurement, manufacturing and supply chain of Drug Substances (IM, API) and Medicinal products (FDF).
Participation and Coordination of Corporate Quality Management activities; QM Compliance Process Responsibilities; e.g. Document management, Change control, Deviation, Complaint, CAPA, Trainings
Communication with the manufacturing and development partner and reviewing, advising and compiling of GxP and regulatory relevant documents.
Product Life Cycle Management; Registration, Coordination, Evaluation and follow-up of Changes, Non-conformities which appear in the framework of internal as well as external established processes.
Securing the high Midas compliance level with regard to international cGMP regulations (e.g. EU, US, AUS)...