Description
We are looking for a
Expert in Clinical Quality Assurance (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Coordinate and conduct internal and external audits
- Write and review audit reports and follow-up on CAPA actions
- Ensure the follow-up of major and critical audit findings and quality issues to ensure that appropriate actions have been taken
- Assist in the identification of areas of potential quality risks and compliance issues
- Ensure the quality assurance database are up-to-date and write and approve QMS document with GCP and GVP relevance e.g. SOPs guidelines
- Act as contact person for 3rd parties
Your qualifications
- In-depth experience in Clinical QA for investigational and marketed medicinal products
- Professional experience in Pharma
- Excellent knowledge of GCP, Clinical Trials and Data Management
- Special knowledge in auditing, authority inspections, EU/US laws and regulations
- Fluency in German and English
Skills:
- Quality manager