Hadeer Abdelhameed Kamal

Supply chain quality officerFull Time

• Job Details:• Maintenance of the compliance to the local BOH regulations • Governance & internal organization • Product quality assurance & operations • LSP / contractor management & oversight • Responsible for managing and supporting Viatris as per Pfizer TSA & Revised TSA Service agreement in operation Activities including : ­ Over printed operation (Batch record) ­ Return ­ Complaint ­ Vehicle and warehouse temperature data review Deviations Change Control

Quality Management System SpecialistFull Time

• Job Details: Preparing and maintaining the Quality Management System Documentations  Plan and coordinate Internal Audit, follow up closing findings, and report to top management.  Plan, supervise staff training and suggest training needs based on Quality activities.  Monitor corrective and preventive actions assist in the development, implementation and review of standard operating procedure.  Participate to the tests on trace-ability & lead its improvements  Participate in external Audits and follow up its action plan to be closed.

Regulatory Affairs SpecialisttFull Time

• Job Details: Prepare and maintain technical files for regulatory documents as necessary to obtain and sustain product approval.  Review finish product raw materials, labeling changes, specification sheets and test methods for compliance to regulations and policies.  Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory methods, compliance test requirements or clarification and follow-up of submissions.  Manage, Analyse and follows up customer complaints closure and related corrective and preventive actions.  Coordinate recall, vigilance activities as necessary  Represents and provides regulatory guidance within the cross-functional team for new product development/sustaining projects  Participate in external audits for notified certifications bodies and governments (external, MOH).