Mariem J.

 Analyze Group validation repositories and assess gaps with site documentation and practices.

 Monitor validation lifecycle management process steps and verify compliance with regulatory requirements.

 Work cross-functionally and approve validation protocols written by various validation experts (manufacturing, packaging, cleaning, computerized systems, analytical, utilities, infrastructure).

 Make decisions on the validated status (or not) of equipment and processes within the deadlines associated with projects or products to be delivered to various markets.

 Participate in project teams to ensure validation repositories are well integrated into project management.

 Update validation status reports as product approvals occur.

 Participate in the writing of validation reviews and change requests associated with periodic reviews.

 Reduction of a backlog of complaints, field investigation

 Writing response reports to authorities (France, Germany, Canada...)

 Write installation specifications (transport and connection modules CDC...) and coordinate the activities of various service providers.

 Risk analyses related to energy and work environment.

 Write quality and validation documents (protocols and test reports, procedures, etc.).

 Implement Lean tools (5S, batch change optimization, flow optimization, simplifications, VSM design, etc.).

 Write instruction standards and operational training.