Global Internal Quality Auditor

vor 2 Wochen

Oberursel, Hessen, Deutschland Fresenius Kabi Vollzeit

The Global Internal Quality Auditor is responsible for performing global internal quality audits and to assist the Director Internal Audits to continuously further develop the global audit systems in terms of planning, evaluating and documenting and adapting to industry and regulatory trends.


The global internal quality audits cover our Manufacturing, Services, Sales and Marketing, and R&D organizations located across the world according to various external standards such as EU-GMP, FDA cGMP, Medical Device regulations, Pharmacovigilance regulations ISO 9001, ISO 13485 and the adherence to Fresenius Kabi's internal standards as defined in global SOPs.


The position reports directly to the Director of Internal Audits with the possibility to mid-term further develop in terms of responsibility or hierarchy.

The position requires frequent travelling in the area of 50%, on occasions on short notice.

Your assignments

Execute Audits

  • Leads the planning and execution of internal quality audits according to relevant international standards and local regulations, and Fresenius Kabi 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 riskbased decisions and communicates to the Auditee as well as Fresenius Kabi 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

Evaluates trends

  • In internal audit
  • In authority findings
  • In regulations, norms and standards and
  • Initiates adaptation of the audit content / process

Knowledge transfer

  • Peer reviews other auditors audit reports for completeness and overall quality
  • Provides training
  • Provides support to improve Internal Audits Quality System
  • Leads / manages different Internal Audits projects

Profile:

  • 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, cross functionally and under pressure
  • Demonstrated ability to make riskbased 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.
This

  • Auf einen Blick
  • Standort:
  • HessenOberursel
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Qualitätsmanagement / Umwelt
  • Arbeitsverhältnis:
  • UnbefristetVollzeit
  • Unternehmen:
  • Fresenius Kabi
  • Referenznummer:

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