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Quality Assurance Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Natural, Sap
Projektbeschreibung
REFERENZNUMMER:
307331/11
IHRE AUFGABEN:
-Ensure that products, systems and facilities are in a state of sustainable compliance with the requirements of cGMP and regulatory authorities
-Responsibility for all quality matters related to the activities performed in the production and during process development
-Ensure efficient and effective quality assurance activities at required cGMP level
-Ensure that the products are manufactured according to cGMP requirements
-Review and approval of SOPs and other quality related documents
-Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation
-Perform QA release of batches and intermediates
-Set batch status in LIMS and SAP, excluding QP release
IHRE QUALIFIKATIONEN:
-Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements
-University degree in natural sciences, medicine or pharmacy or professional scientific, medicinal or pharmaceutical training and profound working experience under cGMP
-Know-how regarding quality assurance principles (cGMP)
-Profound know-how regarding Quality Assurance
-Know-how regarding risk management
-Good negotiation skills
-German and English language skills, in both written and spoken form
WEITERE QUALIFIKATIONEN:
Quality manager
307331/11
IHRE AUFGABEN:
-Ensure that products, systems and facilities are in a state of sustainable compliance with the requirements of cGMP and regulatory authorities
-Responsibility for all quality matters related to the activities performed in the production and during process development
-Ensure efficient and effective quality assurance activities at required cGMP level
-Ensure that the products are manufactured according to cGMP requirements
-Review and approval of SOPs and other quality related documents
-Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation
-Perform QA release of batches and intermediates
-Set batch status in LIMS and SAP, excluding QP release
IHRE QUALIFIKATIONEN:
-Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements
-University degree in natural sciences, medicine or pharmacy or professional scientific, medicinal or pharmaceutical training and profound working experience under cGMP
-Know-how regarding quality assurance principles (cGMP)
-Profound know-how regarding Quality Assurance
-Know-how regarding risk management
-Good negotiation skills
-German and English language skills, in both written and spoken form
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, SAP Entwicklung