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

Details

Beschreibung

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

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