Quality Manager Sterile Manufacturing (m/f)

Fresenius Kabi Austria GmbH
  • Graz
  • Vollzeit
  • Berufserfahrung
  • 8.5.2019

Fresenius Kabi Austria, with headquarters in Graz and further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1400 employees and ranges among the top enterprises of the region.

Quality Manager Sterile Manufacturing (m/f)

Ihr Aufgabengebiet:

  • Manage GMP/MDR/GDP quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers by
  • Planning and executing vendor audits, including monitoring of CAPA progresses till completion
  • Negotiate, establish and maintain quality agreements
  • Perform Gate Reviews for PPQ readiness
  • On-site presence during critical activities (e.g. PPQ campaign, Tech Transfer, HA inspections)
  • Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate
  • Ensure Inspection readiness of all DP/MD/FP Vendors
  • Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to DP, Medical Device, Packaging and distribution
  • Manage GMP compliance during Tech Transfer of DP manufacturing, assembly, Testing and packaging by
  • Authoring, reviewing, approving, as applicable, protocols, plans and reports (e.g. Validations)
  • Identify the risks and establish appropriate mitigation plan

Wir erwarten:

  • University degree (e.g. natural sciences, pharmacy, engineering (BA, BSc, MA, MSc, PhD)
  • Minimum seven years' experience in a Quality function with increasing levels of responsibility in the biotech/pharma industry
  • Strong understanding and interpretation of EU and US medical device regulations, ISO 13485, GMP requirements for sterile manufacturing and combination products
  • Experience with regulatory agencies such as the FDA, EMA, etc.
  • Direct experience with GMP as well as clinical and commercial quality assurance
  • Proven success in third-parties quality management with clinical and commercial products
  • Excellent communication skills in English, both written and oral, knowledge of German is an asset
  • Ability to work effectively in a team-oriented environment
  • An enthusiastic personality with drive and intensity as well as skills in leadership
  • A goal oriented and committed approach to tasks and follow-ups
  • Solution oriented thinking and willing to make decisions
  • Self-motivated and flexible

Wir bieten:

  • Very diversified tasks in a long-term and stable employment
  • Very good working environment in a young, dynamic team
  • Trainings and personal development within the company
  • Career opportunities in an international pharmaceutical company
  • Attractive, performance-oriented payment (annual salary of min. Eur 50.000; increased salary dependent on professional experience and/or qualifications)

Einsatzort:

Graz

Ihre Ansprechpartnerin:

Fresenius Kabi Austria GmbH
Personalabteilung
Mag. Michaela Goecke
Hafnerstraße 36, 8055 Graz
www.fresenius-kabi.at

Fresenius Kabi Austria GmbH

Gesundheitswesen, Soziales
501+ Mitarbeiter

Über uns

Fresenius Kabi in Österreich hat sich auf die Entwicklung, Herstellung und den Vertrieb von Produkten für die Infusions- und Ernährungstherapie spezialisiert. Mit unserem umfassenden Portfolio an intravenös verabreichten Arzneimitteln und Ernährungsprodukten gehören wir…