Corporate Quality Manager (all genders)
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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. Thats 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 the work for our customers and in the development of your own skills.
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. Thats 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 the work for our customers and in the development of your own skills.
Required Experience:
Manager
About Company
Where people make the differenceEveryday 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 transf ... View more
