Ali Benrahou

• • Main projects : SAP, MES, Veeva Vault , LIMS deployments

• o Ensure compliance of regulation on processes for qualifying on topics such as computerized systems (CS), process and laboratory equipment's, facilities, and utilities in line with cGMP requirements, data integrity, GxP regulations, international and company standards. Provide expertise to Qualification/Validation teams. Defend company's interest regarding Qualification/Validation and ensure they are anticipated in the company.

• o In charge of maintaining the valid status of all the internal NPS GxP "Yes" of Marcy site (validation phases and strategies, deliverables, periodic reviews , obsolescence strategies , Change Control Monitoring ..) for Quality Control , R&D, Industrialization, Clinical Affairs departments

• o Updating the NPS Validation procedure for EMEA sites based on GAMP 5 Approach

• o Participating as an auditee (FDA- MDSAP- GMED inspections)

• o Internal Auditor

• • Projects : SAP HANA & Windows 10 upgrades – Monolot France – HR Spreadsheet – Trackwise

Optimization – MDM R&D v2 – ERP Legacy Archiving –Signavio Process Tool – GCS Portal secured in the

cloud

• o Develop, support and implements basic validation initiatives as defined in site goals and objectives. Responsible for various validation tasks within the validation lifecycle

• o Lead assigned validation projects with minimal supervision by coordinating, directing and coaching the validation activities of project team members.

• o Assure that robust validation principles and practices are implemented. Ability to lead risk assessment teams.

• o Assure project timelines and compliance to regulatory requirements and internal procedures are achieved.

• o Communicate validation status, as necessary, raises issues and concerns during project lifecycle.

• o Assure validation documentation is generated, reviewed and approved in accordance with documented procedures. Design and deliver validation training to site validation trainers and to project teams as required.

• o

◦ ·Participate in the definition of change control process definition. Support change control processes in support of system changes, re-validation, and re-qualification initiatives. . (in Remedy and Service Now tools)

• o Provide change control training as requested (in Remedy and Service Now tools)

• o

◦ ·Support supplier and internal audit initiatives related to validation activities. Interface with external organizations and supporting functions.

• o Develop, review and lead the execution of Validation Plans and activities in accordance with documented procedures.

• o Participate in the implementation of global validation objectives and participates in the definition and implementation of global processes across all sites and subsidiaries.