Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports) according to company procedure and in compliance with regulatory mentorship.
Supporting R&D teams during the process characterization phase.
Reviewing and approving of process characterization documents.
Responsibility for the validation assessment on changes and deviations (approval of deviation and changes).
Preparation and maintenance of a detailed continued process verification plan.
Assessing and approving of Product Quality Reviews.
Key requirements:
Master in Chemistry, Biology, Biotechnology, chemical engineering or equivalent.
Experience in project management, preferable in Operations, MSAT, Quality and Compliance.
Experience in interaction with different collaborators within an organization and with regulatory agencies (Swiss medic, FDA etc.) would be an advantage.
First experience in mammalian is an advantage.
Ability to work on different tasks simultaneously and to work towards deadlines.
Proficient communication in English (written and spoken), additional proficient communication in German is appreciated.
Sounds like you? Send your CV to Daria at d.finikova@panda-int.com or call +31202044503.