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) Cooperation in inter-divisional, Midas Pharma group-wide and / or cross-company projects. Supplier Qualification including documentation, coordination and follow-up of supplier and product documentation such as (but not limited to) Drug Master Files, Dossiers, Site Master Files, Validation documents. Communication with the manufacturing and development partners and reviewing, advising and compiling of GxP and regulatory relevant documents and certificates. Audit/Technical Visit of suppliers Regular business trips. Your profile Graduation in Science e.g. Chemistry, Pharmacy, Biotechnology is also preferred. Minimum 5 years of working experiences in the Pharmaceutical Industry Minimum 3 years in Quality Management aspects (e. g. Auditing, Project Management, Production, Validation, QA, QC etc.), auditing experience is preferred. Excellent knowledge of national and international pharmaceutical guidelines (e. g. EU GMP Parts, WHO-Guidelines, ICH-Guidelines, US FDA, cGxP guidelines etc.) Business/Technical fluent English skills Experience in working in cross-functional project teams High social competences, good team worker Flexibility and ability to work in fast developing environment Effective Time Management skills About Us Where people make the difference Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference. We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.
