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

Audit and Inspection Preparation Manager (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Support

Projektbeschreibung

REFERENZNUMMER:

316418/11

IHRE AUFGABEN:

-Prepare and carry out FDA inspection and possible audits
-Write reports as per assigned timelines
-Identify/handle non-conformances pro-actively
-Provide GMP and ideally GCP oversight of the inspection
-Supervision of specific risked-based inspections and audit plans, review resulting CAPAs, request additional audits as required (e.g. potential data integrity issues)
-Ensure QA CRO oversight
-Support QA GOP review

IHRE QUALIFIKATIONEN:

-Degree in Life Sciences, pharmaceutical or other related science or equivalent experience
-FDA inspection and auditing experience, knowledge of GMP and ideally GCP/ICH guidelines
-Strong background in research & development, manufacturing and quality control allowing for understanding all departments needs and constraints
-Extensive knowledge of quality management systems for compliance with ISO 13485, ISO 9001 and 21CFR820, in the medical device industry from establishment to implementation, maintenance and continuous improvement
-Work experience in Quality Assurance and in a Clinical Development department
-Experience in managing authority inspections
-Good communication and negotiation skills
-Fluency in English, in both written and verbal form

WEITERE QUALIFIKATIONEN:

Auditor

Projektdetails

  • Einsatzort:

    Indemini, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    10 MM

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland