Get AI-powered advice on this job and access more exclusive features.
Direct message the job poster from Coopers Group AG.
Responsibilities include:
Designing the process validation strategy, preparing validation documents (study design, protocols, and reports).
Supporting R&D teams during the process characterization phase.
Reviewing and approving process characterization documents.
Assessing and approving changes and deviations during validation (including deviation and change approvals).
Preparing and maintaining a detailed continued process verification plan.
Assessing and approving Product Quality Reviews.
Key requirements:
Master's degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or an equivalent field.
Experience in project management, preferably in Operations, MSAT, Quality, and Compliance.
Experience working with different collaborators within an organization and with regulatory agencies (Swissmedic, FDA, etc.) is advantageous.
First experience in mammalian cell processes is an advantage.
Ability to handle multiple tasks simultaneously and meet deadlines.
Seniority level Mid-Senior level
Employment type Temporary
Job function Production
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr