freelance -Quality Expert for Biologics Process (f/m/n)

  • Position zu besetzen ab 4. Juli 2022
  • Permanent-ID OCR-FL-1893
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland
  • Kategorien Freelance/Contracting, Pharma

Experienced and hands-on candidate :
Tasks:
• Leadership and support in BLA/ Biologics Process Knowledge (DS) and Quality affinity (or QA experience)
• Documents must be created and reviewed

Skills:
• Knowledge of Biologics Process requirements in various areas e.g.:
o Filters & FITs,
o Process Control Strategy and Continuous Process Validation,
o Hygenic Design,
o Annex 1
• Understanding of FDA reporting requirements, Risk assessments under BLA

Additional information:
Project start: 04.07.2022
Project duration: 6 months
Remote share: 40 %
Workload: 4-5 days / week