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 1600 employees and ranges among the top enterprises of the region.
Shortfacts
- Einsatzort:
Graz - Ausmaß:
Full-time - Eintrittsdatum:
asap - Anstellungsverhältnis:
unlimited
We are caring for our employees
- Reliable employer
- Strong global growth
- International career opportunities
- Comprehensive education and training
- Homeoffice
- Jobticket
- Active health promotion
- Free parking space
- Bikeleasing
- Canteen
- Joint company events
Ihre Ansprechpartnerin
Your contact person
Fresenius Kabi Austria
Mag. Michaela Illek
Hafnerstraße 36
8055 Graz
karriere-fresenius-kabi.at Senior QA & Project Manager (m/w/d)
Your tasks
- QA Support and Advice: Provide support and guidance to central teams, local QA, QC, and plant teams to address compliance gaps and enhance local knowledge and skills.
- Hands-On Approach: Collaborate with organizations to prepare documentation, ensuring knowledge transfer and skill development at the plant level.
- Audits and Inspections: Conduct onsite and remote assessments in an audit/inspection style to verify compliance with standards and readiness for authority inspections.
- Participate in global quality system harmonization initiatives.
- Develop and review global SOPs.
- Support supplier audits and ensure global SOPs and processes are implemented.
- Prepare organizations for regulatory audits, conduct pre-audits, and provide support during and after inspections.
- Central Function Activities: Manage tasks such as SOP distribution, eDMS transfers, KPI reviews, audit outcome reporting, quality culture projects, training setups, PQR reviews, and SharePoint updates.
- Lead harmonization and critical business projects.
- Regulatory Monitoring and Improvement: Track GxP/ISO regulatory developments and propose quality improvement initiatives to local and QA management.
- Documentation: Prepare and revise quality management documents in line with GMP, ICH, ISO, and applicable national/international legislation.
- Quality Initiatives: Execute quality improvement projects in close collaboration with Competence Centers.
Our expectations
- Educational skills: MSc in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education.
- At least 5 years of experience the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, GMP/cGMP/21 CFR guidelines, WHO GMP and ISO 9001/13485.
- Management skills are important as well as being able to organize and coordinate 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 and as well strong integrity.
- Routine travels for on-site support of organizations.
We offer
- International challenges in a dynamic corporate environment
- Corporate social events
- Attractive performance-related salary package (annual gross salary starting at € 80.000,-, overpayment depending on occupational skills and experience)
We are caring for our employees
- Reliable employer
- Strong global growth
- International career opportunities
- Comprehensive education and training
- Homeoffice
- Jobticket
- Active health promotion
- Free parking space
- Bikeleasing
- Canteen
- Joint company events
