Description
We are looking for a
Validation Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in the Basel region
Branch: Erbringung von sonstigen Dienstleistungen a. n. g.
Your tasks:
- QA - periodical review of current equipment
- Working systematically on gaps notified during quality review
- Issuing of quality documents related to Annex 11 / CFR Part 11 compliance and performing the periodic review of computerized systems including the definition of further actions
- Regulatory gap analysis regarding current GMP requirements
- Risk analysis
- Follow-up of action items
Your qualifications
- Very good QA and GMP knowledge
- Understanding of GMP compliance requirements
- Document writing skills
- Good communication skills
- Basic knowledge of computerized systems and preferred additional IT knowledge
- Fluency in German and English
- High degree of flexibility and social competency
Skills:
- Quality management employee