Ghislain Avot

At GSK at Waver in QA Release department electronic check-list project management Coordination and preparation of weekly meeting Coordination of parallel subjects link to the project as digital signature for documents send to national authority and local opercative Company (LOC) of GSK in country Management of the Change Control link to this project and evaluation of the impact in the different area Leading of Steering Comitee QP delegates support Double-check for the certification of batches before being shipped to the country to ensure that all requirements are met (Regulatory status as change control status, artwork, etc..) Participation to worshop to simplify and improve these certification double-check Treatment and following of blocking point for certification and release of batches. Lead of auto-inspections (L1) Launch of the 1st Shingrix batch on the Chinese Market Point of contact for the LOC (Local Operative Company) and coordination of actions Preparation the submission documents to be delivered to the LOC and to the Chinese National Health Authority

At Baxter at Lessines in QC department After an FDA audit on another Baxter site an on Lessines Baxter site, several observations were written in the audit report. Especially 2 observation were applicable for Lessines Baxter plan and due to the submission of a new product to the US the FDA will audit the Baxter Lessines plant, these 2 observations had to be treated: - Increase of Out Of Limit (OOL) bioburden tests (microbiological product testing before sterilization) in 2018 - Not enough causes were identified after the Investigations initiation after OOL bioburden tests Coordination of the investigation Gemba on field in formulation & filling department and Quality Control (QC) laboratory Planning of weekly meeting with all the stake holders Communication of the developments to the top management (Manufacturing & QA Director, QP) with presentation and approved reports. Leading the corrective and preventive action implementation and following projects on-going which are aiming the causes identified Writing of a report for the FDA audit on Baxter Lessines plant in 2019 for this point Improvement of investigation method (in the QC department responsible to initiate and close investigation) Improvement of investigation check-list/file use Training for production on microbiological evaluation and its potential impact in case of unplanned event

At GSK at Waver in QA Release department Point of Contact for Shingrix vaccine Release for the US - Coordination and preparation of Release File for Shingrix and sending it to the CBER (Analytical Control Laboratory of the FDA). Implementation of electronic submission. - Improvement of day to day Shingrix release process and coordination with supply department, CBER and other releasing site for Shingrix (as GSK Marietta plant (US)) - Analysis of Release KPI, communication to stakeholders. - Participation to Committee for Shingrix -Supply Task Force: prioritization of batches for supply chain department and release department according to batch availability and compliance and supply need. - Technical Life Cycle Management (TLCM) - Site conformance responsibility Review and comparison of submission file vs operational documents Japan first submission - Creation and implementation of the methodology to the submission part: Way of working developed and implement for the deviation listing Following of the first submission

At GSK at Waver in manufacturing unit of vaccine bulk LVV (Living Viral Vaccine) - Preparation and leading de meeting between production managers and production operators and other stakeholders depending on the issues identified (Quality Assurance/Quality Control , Technical Services, Calibration and measurements, etc...) => Organization and realization of gemba with operators and investigation team. => Approval of impact evaluation and root-cause analysis => Recurrence analysis and collaboration with department responsible impacted for implementing CAPAs and/or remedial action for avoiding reccurences. - Leading CAPA Comities as Compliance: KPI, creation CAPA, challenge of task (creation or closure) Leading Director Reviewing Board if necessary (Critical deviation/CAPA or Major complex deviation/CAPA - Participation to Manpower Comity Challenge to decrease recurrence and implement continual improvement actions. - Treatment of major and critical complaints & improving complaint redaction and approbation - Writing Periodic Review (trimestrial/annual) for Calibration & Measurement, Qualification & Validation - Verification of action completion with gemba, audit or effectiveness => Coordinator for the response to an internal audit of technical services by GSK global Quality Proposition of actions and coordination for the response Writer and presenter of the response presentation for audit closure and for the closure report.