Key Responsibilities: Responsible for meeting assigned goals in technical and final release review including, but not limited to: • Review, and verify executed batch records of MEDICAL DEVICE• Review analytical batch records • Confirm the relevant quality control results are within acceptable limits. • Review and complete records ensuring compliance with applicable SOPs and regulatory regulations. • Communicate with CMOs on missing documentation and error corrections • Archiving of the entire batch documentation • Responsible for reporting all variances, errors and deviations to Quality Assurance. • Manage Records in e-systems (e.g. Veeva systems ) • Able to collaborate on complaint and/or nonconformance reports according to Santhera procedure. • Performs other duties as assigned by the line management

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Quality Control