Imane Zoubaa Sekkat

• Ensure the management of Quality Control and Quality Assurance activities under the best conditions of quality, cost, lead time, productivity, and safety, in accordance with product registration dossiers, while complying with current regulations (GMP, GLP, GDP) and applicable procedures.

• Manage, organize, and optimize the resources of the Quality Assurance and Quality Control departments (Quality services): human, logistical, material, and financial resources.

• Lead, and coordinate the activities of the Quality services, ensuring the maintenance of high-performance levels and staff qualification.

• Lead Corporate/Customer audits and regulatory inspections readiness activities.

• Provide Quality leadership during Corporate/Customer audits, as well as regulatory Inspections (ANSM: French Authorities, DMP: Moroccan Authorities, West & Central Africa Authorities).

• Define, analyze, and update the Key performance indicators related to Quality. Lead information meetings for the staff of the Quality service to raise awareness of objectives and achieved results.

• Collaborate with involved departments in managing site production investments by establishing contact with suppliers, studying technical solutions, and participating in supplier selection.

• Collaborate with the Industrial Director and the Qualified Person in developing 3-year plans.

• Ensure compliance with the operating and investment budgets

• Management of the Quality Control team (15 people) to achieve compliant sampling, and testing of raw material, finished products, packaging material and stability studies samples in a timely manner

• Ensure the release or rejection of raw material and packaging material

• Ensure the conformity of the finished products and stability studies

• Approval of stability reports

• Perform as a subject matter expert during audits and inspections

• Perform as an internal auditor for the site

• Management of laboratory investigations and OOS/OOT including remediation of potential compliance concerns

• Management of QC CAPA's, deviations, and change controls

• Maintain accurate and updated QC documentation: SOP's, analytical methods...

• Ensure compliance with GMP regulations, local authorities' regulations and Servier Group guidelines

• Management of cleaning validation and process validation activities

• Ensure compliance to the EHS Group requirements

• Monitoring of QC relevant KPI's

• Management of the QC budget and investments

• Management of 15 people

• Approval of Product Quality documentation

• Approval of protocols and reports related to quality operations: Metrology, qualification and process validation

• Management of cleaning validation, process validation, analytical validation and computerized systems

• Management of Deviations, OOS/OOT, CAPA and Change Controls.

• Management of product complaints, & leading the related investigations

• Ensuring the writing of Annual Product Reviews within the set deadlines

• Leading audits & inspections preparation (ex: WHO, Sanofi global quality audits, customers and MoH inspections)

• Periodic suppliers audits and internal audits as lead auditor

• Coordination and tracking of the action plans from audits and inspections

• Implementation and monitoring of KPI's