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(senior) consultant gmp

München
Granzer Pharma
Consultant
Inserat online seit: 7 Juni
Beschreibung

Granzer Pharmaceutical Services GmbH was founded in 2022 as a spin-off of Granzer Regulatory Consulting & Services GmbH. We are a Pharmaceutical Service Provider and Consultancy for the Development, Manufacturing and Quality Assurance of Medicinal Products. Our focus is the EU Import, Storage, Distribution and EU-Release of Investigational Medicinal Products, supporting the Clinical Trials of our Clients.For our team in Munich, we are looking for aResponsibilitiesProvide expertise and consulting on GxP-related items to our clientsProvide QA services to our clientsAdvise our clients in vendor selection and qualification activitiesSupport the import and batch release processes for client IMPSupport clinical distribution activitiesSupport and/or perform GMP/GDP auditsSupport inspections by authorities, client audits and self-inspectionsSupport and continuously improve our Pharmaceutical Quality SystemSupport internal QA activitiesQualificationsAcademic degree as a pharmacist or degree in a Life Science related fieldAt least 10 years of experience in the pharmaceutical industry with relevant experience for the position (e.g. Quality Assurance, Quality Control, Production)Excellent knowledge of GMP/GDP regulations in Europe and USQualification as Qualified Person (according to Art. 49 of Directive 2001/83/EC) would be a plusExperience as auditor would be a plusStrong teamwork ethic and sound organizational skills for functioning with a high degree of independence on projects with minimal supervisionFlexible, scientific working style and willingness for continuous educationWillingness to travel (e.g. audits, meetings with clients and CDMO)Fluency in English; German would be a plusA dynamic and friendly atmosphere with flexible working hours, working with highly motivated professionals and with international clients. Opportunities to develop and grow personally, to get exposure to a multitude of exciting projects and to contribute to the development of a growing organization. A culture of independent thinkers embracing debate and initiative. #J-18808-Ljbffr

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