Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Contract Manufacturing Quality Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Design
Projektbeschreibung
REFERENZNUMMER:
260712/11
IHRE AUFGABEN:
-Prepare Quality Agreements and corresponding Product Specific Requirements (PSRs)
-Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled (in collaboration with other quality functions)
-Provide technical expertise and guidance to the External Quality Small Molecules
-Molecules organization by supporting or managing deviations and investigations, changes, specifications and regulatory submissions
-Participate in due diligence visits to assess CMO Quality Systems for development and processing of investigational medicinal products
-Build strong relationships with both internal and operations units and external CMOs
-Collaborate with internal departments to achieve goals through aligned processes
-Participate in the design, implementation and maintenance of quality systems for Small Molecules for execution of the above function
-Provide equipment/facility qualification and process validation support to Small Molecule programs
-Implement appropriate systems as necessary
-Review and approve validation protocols per the Quality Agreement
-Perform quality risk assessments, develop mitigation plan and follow-up on implementation
IHRE QUALIFIKATIONEN:
-Chemist or Pharmacist qualification is a must
-Profound experience in the pharmaceutical industry (manufacturing, quality assurance or quality control)
-Project experience in a quality role
-Experience in operating quality systems in pharmaceutical operations
-Demonstrated proficiency in interpretations of cGMP regulations, both US and international
-Proficiency in German and English
WEITERE QUALIFIKATIONEN:
Quality manager
260712/11
IHRE AUFGABEN:
-Prepare Quality Agreements and corresponding Product Specific Requirements (PSRs)
-Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled (in collaboration with other quality functions)
-Provide technical expertise and guidance to the External Quality Small Molecules
-Molecules organization by supporting or managing deviations and investigations, changes, specifications and regulatory submissions
-Participate in due diligence visits to assess CMO Quality Systems for development and processing of investigational medicinal products
-Build strong relationships with both internal and operations units and external CMOs
-Collaborate with internal departments to achieve goals through aligned processes
-Participate in the design, implementation and maintenance of quality systems for Small Molecules for execution of the above function
-Provide equipment/facility qualification and process validation support to Small Molecule programs
-Implement appropriate systems as necessary
-Review and approve validation protocols per the Quality Agreement
-Perform quality risk assessments, develop mitigation plan and follow-up on implementation
IHRE QUALIFIKATIONEN:
-Chemist or Pharmacist qualification is a must
-Profound experience in the pharmaceutical industry (manufacturing, quality assurance or quality control)
-Project experience in a quality role
-Experience in operating quality systems in pharmaceutical operations
-Demonstrated proficiency in interpretations of cGMP regulations, both US and international
-Proficiency in German and English
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Sonstiges