Beschreibung
We are looking for a
Process Validation Expert - Biotech (m/f)
Reference: -en
Start: 01/18
Duration: 9 MM
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible to write process validation reports which will serve as source documents for a BLA (Biologics License Application)
- Author process validation reports for biotech drug substance processes (Upstream and Downstream)
- Analyze and evaluate process data from executed validation studies
Your qualifications
- BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology
- Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP)
- Experience in process validation
- Expertise in writing technical reports in Englisch
- Experience in regulatory affairs particular in writing module S25 of advantage
- Fluency in English, German advantageous
Skills:
- Qualification/validation specialist