:Support the Sterility Assurance Manager and the Sr Sterile Operations Manager in implementing the new Annex 1 guidelines, including conducting GAP assessments and FMEAs to evaluate the risk of microbial, pyrogen, and particulate contamination.
Additionally, contribute to the development and implementation of the Contamination Control Strategy and CAPA plan.Evaluate Sterility Assurance topics related to new projects, such as new departments, manufacturing lines, and processes/products introduced.Assess aseptic practices and interventions to reduce the risk of aseptic manufacturing processes and...