The role involves comprehensive on-site supervision of cell bank and upstream bulk liquid production processes including weighing, compounding, and cleaning
Job Summary
The role involves comprehensive on-site supervision of cell bank and upstream bulk liquid production processes including weighing, compounding, and cleaning.
Candidates will be responsible for auditing and optimizing quality management documents while reviewing batch records and managing deviations or CAPAs.
The position requires supporting product release activities and participating in Out-of-Specification (OOS) event investigations within a biopharmaceutical setting.
Matching Summary
The role involves comprehensive on-site supervision of cell bank and upstream bulk liquid production processes including weighing, compounding, and cleaning.
Skills & Requirements
Must-have
Cell bank upstream production oversight
SOP audit and optimization
Batch record and data review
Deviation and CAPA management
OOS investigation participation
Environmental monitoring management
Nice-to-have
Technical transfer support
Regulatory filing assistance
Supplier qualification experience
Cross-functional collaboration skills
Key Requirements
Bachelor's degree in Bioengineering or related field