Cherif Wassil AFIR

• Preparation of Summary of product characteristics & Patient Information Leaflet labels for submission to Health Authorities (Registered products/NCE/ line extension/Early Access),

• Ensure tracking, documentation and follow up of labeling projects in PfLEET, GDMS and other systems,

• Participate and support during audit and support HA query regarding labeling delivery,

• Ensure labeling submission compliance as per local and internal SOP.

• Provide Quality Check support to labeling colleagues,

• Produce of other labeling related documentation such as comparison tables,

• Ensure tracking and follow up of labeling projects in appropriate systems,

• Maintenance of workflow management tools and mailboxes.

• Ensure QA standards are maintained in control of documentation, staff training, facilities, and equipment in a product lifecycle phase appropriate manner, and reports compliance to SOP requirements and GMP standards,

• Review Batch records, and associated documentation to ensure that products meet quality specifications before release for distribution.

• Contribute to the identification and implementation of Corrective and Preventive Actions (CAPA) in response to quality issues, deviations, and non-conformances.

• Maintain effective communication and partnership with Operations and Materials Management department.