Regulatory Compliance Consultant
Our client, an international company focused on innovative breakthroughs in healthcare through the collection, processing, storage, and distribution of donor material, is currently seeking a Regulatory Compliance Consultant to join their team. This person will be responsible for ensuring medical laboratory compliance with Germany licensing processes. This project is expected to last 3-4 months.
Responsibilities:
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Participating in the development of operational policies, procedures, and guidelines for the organization
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Overseeing the training program for staff on blood product collection, including apheresis procedures (leukapheresis)
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Establishing and maintaining standards of performance
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Ensuring competency and appropriate licensure of personnel
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Participating in any onsite inspections by authorities and other representatives
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Establishing and implementing competency
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Delegating responsibility of blood bank staff
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Reporting adverse events as required by regulatory agencies and accrediting organizations
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Ensuring that all mechanisms of QC are followed to secure the quality of the product (ex. reviewing test results to ensure that processes are being followed correctly and results are accurate, traceability of tissues and cells, etc.)
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Ensuring that processes are performed according to GMP guidelines
Qualifications:
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Experience building blood banks or laboratories according to the licensing requirements of regulatory authorities in Germany in the state of Bavaria.
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Experience with haematopoietic stem cells or CAR T cells, including preparations and underlying technology
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At least 10 years of experience in manufacturing blood and/or tissue preparations for kryopreservation under GMP
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At least 2 years of experience in transfusion medicine and / or transplantation of stem cell preparations
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Experience in the preparation of documentation & SOPs
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Knowledge of manufacturing under GMP and related documentation (QMS)
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Has a profound understanding of relevant German legislation
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Fluent in German and English
If you are interested in this position, please send your resume to [email protected]
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