Key responsibilities of the role include:
- Plan, conduct, follow up IT audits of GxP relevant computer systems at Contract Manufacturing
- Organizations (CMO), and Contract Research Organizations (CROs)
- Plan, conduct and follow up internal audits of in-house GxP relevant computer systems and IT infrastructure
- Host and follow-up authority inspections
- Supporting Computer System Validation projects in house
- Quality Assurance oversight of Computer System Validation projects
- Write and review SOPs
- Support continuous improvement projects
- Provide QA related CSV support, advice, and training to internal departments and stakeholders
Requirements:
- Ideally at least five years of professional experience as Quality Assurance and Computer System Validation in pharmaceutical / biotech industry
- Validation in pharmaceutical / biotech industry
- Experience in software validation projects such as eTMF, statistics and EDC software etc.
- Experience as auditor
- Expert knowledge of national and international regulations and standards, e.g. 21 CFR Part 11, Annex 11, GAMP 5
- Good knowledge of relevant in GMP and GCP regulations / guidelines
- Well-organized, structured person with attention to detail
- Excellent communication skills, fluent in German and English (written and spoken)
- Used to work in interdisciplinary and intercultural teams
- Team player with assertive skills, when required
- Able to work independently and solution-oriented
- Excellent application of office software (Word, Excel, PowerPoint and SharePoint)
