Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

QA Manager Combination Product and Device (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Design, Engineering

Projektbeschreibung

REFERENZNUMMER:

335577/11

IHRE AUFGABEN:

-Serve as the Quality Single Point of Contact for allocated Device Development project and ensure all projects follow the applicable risk management procedures, Design Control activities, Design History File and prepare Control Strategy definition
-Collaborate with all QA representatives to ensure quality robustness of the interface between the drug product and the component of the device forming the combination product
-Create and deploy Risk Management plan/report actively participate up to facilitating FMEAs, define delivery system specifications accordingly, including drug product/component interface, and ensure all necessary release GMP documentation are completed
-Actively participate in elaboration of all design control document for the quality area of expertise, including use of statistical techniques to elaborate sample sizes and acceptance criteria

IHRE QUALIFIKATIONEN:

-BS degree in a Life Sciences discipline or chemical/mechanical engineering
-Hand-on expertise in device manufacturing and knowledge of aseptic manufacturing preferred
-Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
-Understanding of the biotechnology industry and specifically combination products
-Sound knowledge of cGMPs and Quality Systems Regulations and Medical Device Directives, ISO 13485:2003 and ISO 14971
-Fluent German and English skills

WEITERE QUALIFIKATIONEN:

Quality manager

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland

  • Projekte:

    798 Projekte Alle anzeigen

use Date;