Description
We are looking for a
Quality Manager External Manufacturing (m/f)
Reference: -en
Start: asap
Duration: 4 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure regulatory conformity through the review of quality and compliance documentation such as analytical transfer protocols, process validation protocols, change requests as well as master batch records produced by external manufacturers
- Negotiate quality agreements as well as monitoring the adherence to such agreements through audits and report findings on a regular basis
- Ensure the CMO is ready for auditing and follow up on CAPAs on site
Your qualifications
- University degree in Chemistry, Biology, Pharmacy and Engineering with profound experience in pharmaceutical quality operations
- Strong knowledge of GMP and various regulatory bodies
- Experience in drug manufacturing and the ability to travel for about 25% of the time, mainly within Europe
- Outstanding communication skills in English in both verbal and written form, German and French skills are of advantage
Skills:
- Quality manager