Beschreibung
For our client in Vet Pharma we are looking for a Consultant (f/m/d) for validation of testing procedure.Start: April 2021
End: October 2021++
Capacity: Fulltime
Location: Friesoythe & Remote (Methodenvalidierung 50% Remote/ Photostabilität 100% Remote möglich)
Background:
Validation of testing procedure for new Microscope and Photostability study for PET Vials in the quality control.
Goals & Requirements:
Feasibility study and validation of procedure on new microscope located in analytical laboratory.
Preparation of Feasibility and Validation - Documents like
• Feasibility Study Plan (including assessment respectively justification)
• Validation plan /-protocol
• Excecution
• Summary Reports in English based on the documentation
• Revision of other GMP-Documents like testing procedure in German language.
Photostability study according VICH and ICH Guidline for Drug Product filled in PET vials
Preparation of Study - Documents like
• Study Plan (including assessment respectively justification)
• Coordination of the execution with analytical laboratory
• Summary Reports in English based on the documentation
Very good knowledge of German and English is required to revise the above documents. Since it is exclusively a question of computerized laboratory equipment and analytical method validation, you should be extremely well versed in dealing with automated laboratory equipment and t method validation requirements.