Fresenius Kabi Austria, with headquarters in Graz and a 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 1600 employees and ranges among the top enterprises of the region.
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Fresenius Kabi Austria
Frau Mag. Michaela Illek
QA Project Manager (m/f/d)
- The position holder needs to provide QA related support and advice (as based on suitable requirements, guidelines and Fresenius Kabi standards) to the local QA, QC and plant teams in order to close possible compliance gaps in the laboratory or production and to further enhance and develop local skills and knowledge in that area.
- Wherever possible the approach needs to be "hands on" and any documentation needed should be prepared together with the organizations for closing gaps, to maximize a knowledge transfer from the position holder to the local staff and increase knowledge at the plant.
- Partly the assessments need to be done in onsite/remote audit/inspection style to verify laboratories and production areas comply to valid standards and are ready for authority inspections.
- Additionally, tasks related to the overall Quality Management System of Fresenius Kabi might be applicable as follows: Participant in global quality system harmonization groups, Issue and review global SOPs, Support in supplier audits, assure that the global SOPs and processes are implemented in the plants/organizations, prepare organisations for authority audits, performance of pre-audits and support during and after audits where applicable, running harmonization projects.
- Summary and analysis of quality metrics, preparation of review of quality metrics with management of organizations and follow-up with related actions
- Recognize and track new developments in Food/GxP/ISO regulations and propose quality improvement initiatives to local Management & local QA Mgmt.
- Preparation or Revision of quality management documents
- Analysis and implementation of guidelines (GMP, ICH, ISO, etc.) and national and international legislation applicable to the work done.
- Execution of Quality initiatives in close collaboration with the Competence Centers of the QM Generics, I.V Fluids & Nutrition.
- Educational skills: MSc in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education
- At least 3 years of experience in either Food Safety/ regulations and/or the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, EU GMP, WHO GMP, CFR210/211, ISO 22000, 13485 and ISO 9001
- Management skills are important as well as being able to organize multiple tasks in several organizations.
- In order to be successful in this position we are looking for a person with good communication skills, confident in English/Chinese as well as strong integrity.
- Constant travels for on-site support of organisations
- Very varied area of responsibility in a complex environment
- Career opportunities in an international pharmaceutical company
- Training opportunities and personal development within the company
- Annual gross salary starting from EUR 45.000,-. The willingness to overpayment, according to skills and experience, is given