This position reports to the Global Commercial QA function and is responsible to manage Quality Systems related to the GMP operations for commercial Products, in accordance with Incyte Standards and Regulatory Requirements.
He/She will also act as primary user support for electronic systems for Documentation (eDMS), Training (eLMS) and Quality Processes (eQMS) management for European based employees.
DUTIES AND RESPONSABILITIES
Collect and issue compliance and QA performance Metrics supporting Functional and Global Quality Management Reviews
Lead periodic reviews of the Change control, deviations, CAPA and audit system to ensure continuous compliance and identify trends and follow-up actions
Manage the Quality Plans pertaining to Commercial QA and ensure completion of commitments
Develop and Maintain the list of approved Commercial GMP/GDP Vendors
Develop and Maintain the Commercial QA external audit plan
Manage the SOP and Technical Quality Agreement periodic review program for Commercial QA
Support the Company Global GMP/GDP Training Program by defining Training requirements applicable to Commercial GMP and conducting SOPs classroom trainings and
Provide support for regulatory agency inspections including retrieving requested files, documents or generating reports from the Incyte eDMS and LMS and eQMS.
Electronic system primary user support for European based employees:
Provide end user initial and periodic training on e-systems
Develop and configure metrics Dashboards
Be the point of contact for first level QA system support
Manage e-systems Master data
Assist with the configuration, testing and validation of Incyte’s e-systems
Partner with the Incyte e-systems super user community to develop user instructions, recommend configuration or process improvements
Collaborate with Global Quality Management System and Systems Administrator.
Perform QC check of controlled documents before approval
Track the internal routing of GxP controlled documents, assuring proper and timely review, approval and effective dating.
Manage and track controlled document distributions to external Incyte partners.
Maintain proper filing and storage practices
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