Your tasks
1. 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.
2. Hands-On Approach: Collaborate with organizations to prepare documentation, ensuring knowledge transfer and skill development at the plant level.
3. Audits and Inspections: Conduct onsite and remote assessments in an audit/inspection style to verify compliance with standards and readiness for authority inspections.
4. Participate in global quality system harmonization initiatives.
5. Develop and review global SOPs.
6. Support supplier audits and ensure global SOPs and processes are implemented.
7. Prepare organizations for regulatory audits, conduct pre-audits, and provide support during and after inspections.
8. 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.
9. Lead harmonization and critical business projects.
10. Regulatory Monitoring and Improvement: Track GxP/ISO regulatory developments and propose quality improvement initiatives to local and QA management.
11. Documentation: Prepare and revise quality management documents in line with GMP, ICH, ISO, and applicable national/international legislation.
12. Quality Initiatives: Execute quality improvement projects in close collaboration with Competence Centers.
Our expectations
1. Educational skills: MSc in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education.
2. At least 5 years of experience in 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.
3. Management skills are important as well as being able to organize and coordinate multiple tasks in several organizations.
4. In order to be successful in this position we are looking for a person with good communication skills, confident in English and strong integrity.
5. Routine travels for on-site support of organizations.
We offer
1. International challenges in a dynamic corporate environment
2. Corporate social events
3. 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
1. Reliable employer
2. Strong global growth
3. International career opportunities
4. Comprehensive education and training
5. Homeoffice
6. Jobticket
7. Active health promotion
8. Free parking space
9. Bikeleasing
10. Canteen
11. Joint company events
Fresenius Kabi Austria
Mag. Michaela Illek
Hafnerstraße 36
8055 Graz
https://karriere-fresenius-kabi.at/
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