Manage third party manufacturers located in this region to ensure a regular monitoring and assessment of contracted GMPs activities.
Serve as functional quality representative of external manufacturing Asia Ensure that manufacturing operations are conducted and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activities Any ad hoc tasks assigned by the reporting Manager
MAJOR DUTIES & RESPONSIBILITIES
Quality Management of third party manufacturers
Perform GMP audits of third party manufacturers and CAPA (Corrective action and preventive action) follow-up.
Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
Management and support product recall and return.
Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
Participate in the evaluation, selection and approval of third party manufacturers
Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
Review of technical reports e.g. stability reports, process /analytical validation reports etc.
Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third party manufacturers.
Perform risk ranking of third party manufacturers.
Manage termination of activity with third party manufacturers
Quality Operations of EM Asia Entity
Management and continuous improvement of Quality Management System (QMS)
Implementation of global quality directives, standards and procedures.
Management of Quality Documentation System, Documentation Retention, Archival and Destruction
Management of Qualifications and Training of Quality/Regulatory personnel.
Management of Self Inspection
Prepare and participate in EM Asia Quality Review
Prepare Monthly Quality Reports for reporting to Global Quality
Collect and consolidate the quality KPI’s (Key Performance Indicators) from Sanofi entities managing third party manufacturers in the region for reporting to Global Quality
Assist Quality and Compliance Manager for the quality support of Sanofi entities managing third parties manufacturers in Asia
Provide quality support to Sanofi entities managing third party manufacturers in the Asia region
Coordinate CMO score card/risk ranking with Sanofi entities managing third party manufacturers in the Asia region
Provide quality support to Sanofi entities managing third party manufacturers in the Asia region for Quality Risk management in case of critical quality issue originating from third party manufacturers.
Quality Support for Transversal Projects
Provide Quality support for transversal project e.g. new product launch, site transfer or repatriation.
Knowledge and Skills:
Experience & knowledge:
At least 8 years working experience in quality or manufacturing in pharmaceutical industry
Degree in Pharmacy / Pharmaceutical Science / Related Science
Ability to work in a matrix organization
Good team spirit and familiar with project development through cross-functional activities
Strong organizational and negotiation skills
Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
Pro-active, well organized with good sense of responsibility
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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