Sara BENNAOUM

> Organize, supports, and manages the company's pharmaceutical activities.

> Certification of drug batches and import requests to competent authorities.

> Management of operations and quality teams:

- Organize and carries out the planning of the operational team, ensures that operations are carried out in accordance with procedures and instructions, and that personnel are authorized.

- Contribute to the definition and implementation of the company's quality policy and promotes the development of conditions for quality improvement. Establishes and monitors departmental performance and workload indicators.

> Participate in management committee meetings.

> Implement and maintain the pharmaceutical QMS in line with company quality policy and applicable regulations.

> Develop and implement internal guidelines, procedures, instructions, etc. with the aim of ensuring that the organization complies with the applicable and current legislation. Develop Master Batch Records and Regulatory Dossiers (Regulatory Submissions, IMPD).

> Carry out audits of customers, subcontractors, and suppliers.

Drafts and signs QTA and QP to QP contracts

> Assist and support other quality activities.

> Participates in project implementation.

> Management of ANSM and European regulatory authorities' inspections

> Guarantee the quality within the entire flow, from raw material to package, with the aim of continuously attaining optimal quality.

> Develop and implement internal regulations, guidelines, procedures, etc. with the aim of ensuring that the organization complies with the applicable and current legislation (on national/local level).

> Maintain the policy lines within the context of the entire quality system and ensure that the entire company adheres to the policy with the aim of being capable of providing optimal quality assurance and to guarantee quality.

> Manage, organize and schedule all quality operations within the organization with the aim of meeting the prescribed quality standards (ATMP GMPs and ISO 13485).

> Stay well-informed about the evolutions and developments, keep his/her knowledge up-to-date within the context of the amendments to regulations with the aim of strengthening his/her credibility by offering a service that is continuously based on updated knowledge.

> Management of the pharmaceutical quality system: drafting of quality documents, maintenance of databases, quality indicators.

> Work on the regulatory framework for advanced therapy drugs.

> Review and approval of stability protocols and reports

> Drafting of an IMPD for a European clinical trial.

> Quality control: development and validation of protocols and analysis methods in collaboration with a subcontractor, management of certificates and requests for analysis, release of raw materials.

> Definition of flow and transport conditions for an experimental drug.

> Drafting and approval of quality contracts with subcontractors

> Internal audits.

> Management of ANSM inspections

> Processing and review of manufacturing, packaging and analytical records of finished products

> Release of batches of finished products

> Management of deviations and OOS results: investigations, impact analysis and trend analysis

> CAPA and Change management

>Drafting of APQR: review and trend analysis of critical parameters of finished products, review and trend analysis of analytical results of water and environmental control, review of changes

> Implementation of group standards according to regulatory developments

> Batch review team management

> Start-up of new Sidi Abdallah site: Qualification and validation of new production lines, transfer of production methods, transfer of analytical methods

> Industrial affairs services: quality support & regulatory affairs M CMC

> Negotiation and Signing of Quality Agreements with group third parties and subsidiaries

> Elaboration of contract templates, European procedure registration,

> Regulatory missions: Annual declaration of psychotropic and narcotic drugs / Request for approvals to the ANSM, Inventory of pharmaceutical establishments.