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Manager/Sr. Manager, QA Product Release

Eingestellt von Real Staffing Group aus Frankfurt am Main

Projektbeschreibung

- Interacts with CMOs to address documentation and compliance issues.
-Conducts risk assessment of operational processes and mitigates risks by performing person-in-plant activities and assists with compliance audits of CMOs as assigned
-Coordinates and/or conducts audits of contracted suppliers and CMOs.
-Serves as QA Lead of quality investigations and CAPA recommendations related to manufactured products.
-Creates, Manages, and improves quality systems and processes that integrate with existing systems, ensuring high quality products and compliance to regulatory requirements.
-Collaborate cross-functionally to solve issues and implment Quality Improvements impacting opreations.
-Assists with audits during due diligence and Regulatory Agency inspections.
-Manages the clinical product disposition process to ensure quality review and release of clinical products in accordance with domestic and international regulations.
-Minimun BA/BS Degree in Biological sciences, chemistry, or related field.
-Minimun 8-12 years of relative progressive GMP biotech or pharmaceutical manufacturing environment experience and 6-8 years of operational quality experience executing, developing, and administrating Quality Systems.

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Sunnyvale, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland