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Contract Manufacturing Quality Manager (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Support, Design

Projektbeschreibung

REFERENZNUMMER:

241729/11

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 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 (must)
-Profound xperience in pharmaceutical in 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

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    7 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland