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Roles & Responsibilities
up to 4k
Perform review and release of materials, including therapeutic products intended for clinical trials and packaging components.
Provide support on Quality matters to Project Management / Operations in the area of clinical packaging, storage and distribution.
Evaluate CAPA effectiveness and identify process improvements.
Review and approval of Change Control, Complaints, and Deviation reports.
Monitor closure of corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformances and deviations.
Manage site SOP System, including review, update and approval of SOPs.
Approve specifications, sampling instructions and other Quality Control procedures.
Review and approval of validation/ qualification documents.
Perform the role of a System Administrator for Quality-related Computerized Systems.
Perform in-process checks during secondary assembly/ packaging activities and inspection of incoming materials, as required.