Job Description
Your mission
- 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)...
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