Senior Global Quality Auditor (m/w/d)

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Ansprechpartner
Nadja Küppers
+49 (0)89 7263 210 – 09
kueppers@ageneo.de
Branche
Pharmazeutische Industrie
Berufsfeld
QM
Region
Hessen

DAS UNTERNEHMEN

Global, innovative healthcare company with production site in Germany (Hessen) is looking for you as "Senior Global Quality Auditor" (m/w/d).

IHRE AUFGABEN

  • Leads the planning and execution of internal quality audits according to relevant international standards and local regulations, and the companys global procedures.
  • Assesses compliance of systems, processes and procedures with relevant audit criteria including global procedures and documents findings in audit reports.
  • Assesses potential compliance risks, make risk-based decisions and communicates to the Auditee as well as the Management.
  • Ensures audit reports are issued in a timely manner and adequate corrective / preventive actions proposed for implementation that address the root cause of identified deficiencies.
  • Performs desktop audits.
  • Knowledge transfer of peer reviews other auditors audit reports for completeness and overall quality
  • Provides training
  • Provides support to improve Internal Audits Quality System
  • Leads and manages different Internal Audits projects

IHR PROFIL

 

  • Diploma or Master degree, preferably in a natural science such as in Chemistry, Pharmacy, Engineering or proven equivalent knowledge by long term job experience
  • Profound knowledge in GXP regulations preferably in the US-FDA environment proven by either 10 years of operational experience in the health care industry or relevant Competent Regulatory Authority
  • Good knowledge in sterile manufacturing and / or active devices and / or computerized system validation
  • Knowledge of EU GMP and/or US FDA /regulatory requirements and expectations concerning manufacturing of Pharmaceuticals: excellent knowledge of cGxP (Eudralex Vol 4 and / or US 21 CFR 210/ 211)
  • Strong interpersonal and communication skills, both written and verbal
  • Fluent in English and preferably in another pertinent language
  • Demonstrated ability to work collaboratively and cross functionally
  • Demonstrated ability to make risk-based decisions
  • Good report writing skills
  • International experience - a plus.
  • Ability and readiness to travel domestically and internationally (up to 50% of work time), on occasions at short notice

BENEFITS

  • innovative, global company 
  • international position
  • motivated Team