Validation Expert

**Your tasks**:

- Support and validation guidance in validation / CSA projects as validation team lead and project management lead
- Support in selection and implementation of appropriate software tools to implement CSA
- Preparation of respective procedures and / or work instructions to support qualification and validation of computerized systems
- Preparation of templates for use in qualification and validation projects
- Auditing of software vendors
- Review of GMP compliant qualification and validation of corporate computerized systems as relevant and used by MIT&DS
- Training of CSA and validation principles within MIT&DS
- Assure that computer software validations are done properly
- Escalation if CSA principles are disobeyed
- Re-qualify software supplier to maintain the qualified status

**Our expectations**:

- Academic degree (Master or comparable degree)
- Profound experience in computerized system validation
- Good knowledge of EU GMP Annex 11 and US FDA 21 part 11 as well as SOPs related to computer software validation
- Good software knowledge (Service Now / Polarion / Office) and basic knowledge of QM principles
- Proactive working and prioritizing of tasks according to the requirements of the project
- Critical, creative and problem-oriented thinking in validation projects
- Teamplayer, appropriate soft skills as well as good leadership skills, high motivation, good in decision-making and reliable
- Good presentation and problem-solving skills
- Experienced in working in multi-cultural teams and changing projects
- Good English language skills
- Global traveling readiness

**We offer**:

- 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 50.000,-. The willingness to overpayment, according to skills and experience, is given

**We are caring for our employees**:

- Reliable employer
- Strong global growth
- International career opportunities
- Comprehensive education and training
- Active health promotion
- Free parking space
- Canteen
- Joint company events

Fresenius Kabi Austria
Frau Mag. Michaela Illek
Hafnerstraße 36
8055 Graz