1. Ensuring that Vaccine BU products and services are in compliance with corporate directives, GxP and local requirements
A. Management of national lot release application
B. Preparation of summary protocol of imported products to submit to Korean Health Authority
C. Preparation of batch release dossier and management of batch release
D. SAP data operation as Quality module
E. Package materials review
F. Management of affiliate SOPs
G. Supporting change control, risk management and recalls
H. Performing/Supporting self-inspection, regulatory inspection and CAPAs
I. Management of deviations, including investigation, root cause analysis, impact assessment, and implementation of corrective and preventive actions
J. Supporting Annual Quality Review and Product Review (PQR)
K. Management of quality events and non-conformances related to vaccine BU products
L. Review and approval of quality-related documents for vaccine BU products (protocols, reports, specifications, etc.)
M. Proactive communication with Korean Health Authorities and manufacturing sites regarding vaccine BU products
2. Management of products technical complaints and CCB (Cold Chain Break) events concerning Vaccine BU products
A. Management of PTC (Product Technical Complaint), including receipt, registration, investigation coordination with manufacturing sites, trend analysis, timely closure in compliance with Sanofi global process, and regulatory reporting to Korean authorities (MFDS/KDCA)
B. Management of cold-chain breaks, including impact assessment and coordination for usage decisions
3. Supporting distribution center to ensure that GSP/GMP is implemented in the warehouse
A. Supporting manager to make usage decisions and salving for defect products
B. Management of KGSP documents and required regulatory dossiers
4. Ensuring that Vaccine BU products are manufactured, imported or distributed appropriately according to quality system.
A. Supporting assessment of sub-contractors’ KPI
B. Management, archiving and change control of quality documents from manufacturing site
C. Document archiving and management for imported products
5. Managing and archiving GxP records, including electronic records in GxP archiving tool and paper records in accordance with RRS (Record Retention Schedule)
6. Managing GxP 3rd parties in compliance with Sanofi process
A. Ensure 3rd party qualification and perform routine management according to the GOP
B. Performs QRA (Quality Risk Assessment) incl. Market research QRA and manage audit program
C. Manage and ensure up-to-date QTP Data Base
D. Ensure appropriate, accurate & up-to-date signed quality agreements are in place.
E. Management of contract laboratories, including:
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Management of test requests and coordination of analytical testing activities
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Document management including test reports, SOPs, and related quality records
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Contract management and quality agreement maintenance
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Troubleshooting and resolution of QC issues and out-of-specification (OOS) results
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Qualification and ongoing performance monitoring of contract laboratories