Wael Kamel Email & Phone Number

Egypt

Assignment to lead External Manufacturing operations covering Projects & supply chain, in addition to Quality activities. Main responsibilities: Project Management activities: -Lead technical discussions with CMOs for new Projects.-Focal point with CMO & internal stakeholders for Manufacture & Supply Agreements (MSA) terms negotiations.-Build Project plans using MS project program and periodically follow up the plan with relevant stakeholders. -Assist in sourcing case process and to provide or compile any necessary information (ex: Due diligence report)- Close collaboration with finance BP regarding calculation of products standard costs based on cogs provided by CMO.- Artworks creation on Adobe illustrator and follow up approval with different stakeholders.Supply Chain activities: - Close collaboration with Finance BP in the annual budgeting process - Lead negotiations with both CMO & internal stakeholders related to routine op. issues. - For Partial toll agreements: o Conduct Monthly MRP for locally supplied materials based on actual stocks at CMO level o Arranging Locally purchased materials deliveries between suppliers and CMO.-Arranging FG monthly production plan with CMO.-Arranging Deliveries of FG Between CMO, Transportation service provider and Distribution center.-VAT Exemption requests prep. & submission.-Activation of Materials Importation process for the Egyptian Market: o Materials Annual Importation plans prep. & submission. o Coordinate with treasury team for Form 4 issuance. o Coordinate with clearance service provider for clearance process. o Build 24 months Materials rolling forecast and share confirmed POs with Suppliers considering the frozen periods. -Negotiate and place orders for suppliers for analytical requirements.-Focal point to follow up with P2P accounting team in case of delays in third parties' payment or to investigate discrepancies in QTYs or prices between POs and GR at CMO level for toll agreements.

Egypt

managing CMOs located in this region to ensure a regular monitoring of contracted activities in accordance with GMP, marketing authorization and quality agreement. Main responsibilities: - Perform GMP audits of third-party manufacturers.- Complaints: Review complaints investigation, CAPAs & effectiveness review and complaints trend.- Participate in product recall.- Change control: Review, perform impact assessment, risk assessment and coordinate CC process. - Deviation and OOS 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-parties.- Management of Quality Agreement with third parties. - Management of Product Quality Reviews (PQR): Review, corrections/follow up .- 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).- Perform risk ranking of third-parties.- Implementation of SANOFI global quality guidelines and procedures.- Management of Quality Documentation System, Documentation Retention, Archival and Destruction- Management of Qualifications & Training of Quality personnel.- Management of Self Inspection- Prepare and participate in Entity Quality Reviews- Prepare Monthly Quality Reports.- Provide Quality oversight and quality support to Sanofi entities managing third party manufacturers in this region- Provide Quality support for transversal project e.g. new product launch, site transfer or repatriation.QMS LEAD for Asia Pacific, Middle East and Africa (AMEA) at SANOFI Consumer Health Care – October 2021 to June 2022 ;- Lead the creation and harmonization of QMS in all CHC EM hubs in AMEA region.

Egypt

Continue my responsiblity to lead Quality Assurance Systems Unit to ensure compliance of the following:1. Quality Risk Managemento Creation & Maintenance of QRM system capable to consistently identify, analyze, evaluate, control, communicate and review of potential or identified risks related to quality or GxP compliance in alignment with global requirements.2. Suppliers Quality Management.o Ensure that all materials' suppliers are complying with SANOFI quality requirements. o Specification Approval for API, Auxiliary and Primary & secondary packaging materials.o Approval of Quality agreements with suppliers.o Conduct audits on Suppliers and monitor the implementation of the relevant CAPAs. 3. External Manufacturing Activities.o Ensure Compliance of Toll-out manufacturers with Quality requirements o Review & approval of Quality agreements with Toll-out manufacturers. o Conduct audits on toll-manufacturers and monitor the implementation of the relevant CAPAs. 4. CAPA management.5. Review & Implementation of Sanofi Global Quality Documents o Ensure the implementation of Sanofi GQDs in all concerned departments.o Follow up the performance of gap analysis for any updated GQD and implementation of any raised actions from these analyses.6. Artwork Management:o Approval of artworks for all products & ensure its compliance with the registered artworks.7. Self inspection program for all site GMP activities o Preparation & execution of annual plan for internal audit for different departments on yearly basis.8. Management of External Audits performed by External business partners or regulatory audits.9. Maintain and supervise the documentation management system for creating, updating, revision, approval and issuing of all GMP documents.10. Conducting & supervising annual GxP Training Program for Industrial Operations Staff.11. Pest Control Program management.

Egypt

Responsible to lead the following activities:1. Suppliers Management.o Ensure that all materials' suppliers are complying with SANOFI quality requirements. o Specification Approval for API, Auxiliary and Primary & secondary packaging materials.o Review & approval of Quality agreements with suppliers.o Conduct audits on Suppliers and monitor the implementation of the relevant CAPAs. 2. External Manufacturing Activities.o Ensure Compliance of Toll-out manufacturers with Quality requirements o Review & approval of Quality agreements with Toll-out manufacturers. o Conduct audits on toll-manufacturers and monitor the implementation of the relevant CAPAs. 3. Review & Implementation of Sanofi Global Quality Documents o Ensure the implementation of Sanofi GQDs in all concerned departments.o Follow up the performance of gap analysis for any updated GQD and implementation of any raised actions from these analyses.4. Artwork Management:o Approval of artworks for all products & ensure its compliance with the registered artworks.o Approval of suppliers proofreading to ensure its compliance with the approved artwork.5. Quality Risk Managemento Creation & Maintenance of QRM system capable to consistently identify, analyze, evaluate, control, communicate and review of potential or identified risks related to quality or GxP compliance in alignment with global requirements.6. Self inspection program for all site GMP activities o Preparation & execution of annual plan for internal audit for different departments on yearly basis.7. Management of External Audits performed by External business partners or regulatory audits.8. Maintain and supervise the documentation management system for creating, updating, revision, approval and issuing of all GMP documents.9. Conducting & supervising annual GxP Training Program for Industrial Operations Staff.10. Pest Control Program management.11. Follow up of CAPA programs implementation on monthly basis.

Egypt

o Validation Officer (from Sept. 2013 till Oct.2016):1. Preparation & Follow up of Validation Master Plan.2. Manufacturing & Packaging Process Validation (Non Sterile, Terminally Sterilized & Aseptic products).3. Aseptic Process Simulation Test. 4. Cleaning Validation & Worst Case Study Creation.5. Hold Time Validation Studies. o Self-inspection Officer (From Oct. 2014 Oct.2016)o Different Activities:1.Responsible for Master Batch Manufacturing Record Review (Non Sterile, Sterile & Aseptic products) 2.Responsible for Production & warehouse SOPs review.3.Responsible for Change control follow up in QA department. 4.Participation in Deviations investigation and management in different production areas.5.Participation in Creation of QA SOPs

Egypt

Post Graduate Diploma, Total Quality Management, A

Bachelor'S Degree, Pharmaceutical Studies, Excellent With Honor

Activities and Societies: SCOPS