Quality Assurance Manager
vor 1 Monat
Grifols is seeking a highly skilled Quality Assurance Manager / Deputy Technical Director to join our team in Germany. As a key member of our Quality Assurance department, you will be responsible for ensuring the efficient and effective implementation of Quality Assurance activities in compliance with national and international GXP requirements and local laws, as well as Grifols internal policies for all products distributed by Grifols Deutschland GmbH.
Key Responsibilities:- Provide Quality Assurance review for storage and distribution of Biopharma and Diagnostics products in Germany.
- Establish and ensure adherence to Grifols Quality-Systems and Policies as well as to European and local directives and legislation.
- Manage relevant QA systems, e.g. product technical complaints, deviations, documentation, change control, corrective actions, trainings and audits according to responsibility matrix and in coordination with the QA team.
- Manage applications for OCABR as well as national release to the German OMCL (PEI).
- Ensure establishment of Quality Management Business Review programs and annual business reports in cooperation with Technical Director and QA Team.
- Support authority inspections.
- Ensure QA relationship and agreements with contracted third parties.
- Issue or review and approve reports for deviations, CAPA, change control and other relevant quality documents.
- Ensure TD/QA onboarding for new hires.
- Serve as the Key User for SAP QA Processes.
- University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master's Degree is also required.
- At least 3 years of relevant experience in Quality Assurance, Quality Control and/or Quality Management.
- Knowledge of Document Management System and Project Management (desirable).
- Good communication and organization skills.
- Structured, self-motivated and results-oriented person, and team player, able to collaborate with cross functional teams to achieve the objectives.
- Fluent German and English.
Grifols is a global healthcare company that offers a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally and provide a comprehensive benefits package, including flexible working hours, home office options, and a competitive salary.
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