Senior Quality Officer

Rueil-Malmaison, Île-de-France, France · Quality

Description

The Senior Quality Officer establish and manage a sustainable Quality Management System supporting the External Network organisation, ensuring full compliance to the cGMP requirements.


KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Ensure compliance of the quality system to cGMP.

Ensure management of controlled documentation

Ensure management and maintenance of the different quality systems: CAPA, deviations, change control, product complaints, supplier complaints.

Ensure that compliance of the Site to GMP and to Norgine procedures is monitored through execution of appropriate self-inspection programme, and that necessary corrective measures are put in place.

Plan the quality activities for the year (Quality agreement, Product Quality review, VMP, Procedures).

Continuously monitor the performance of the EN Quality system reviewing results of KPIs and propose appropriate corrective action.

Review on an annualy basis the overall performance of EN by performing a management review and propose improvement actions.

Coordinate the annual partners performance review

Ensure training of the EN team by ensuring that an induction program is followed for any new comer and by organising GMP training of the EN team as appropriate.

Ensure readiness of the EN site for authorities inspection and customer audits

Coordinate post-inspection activities to ensure that timelines for commitments to the Regulatory Authorities are met.

Leadership and membership/management of projects as appropriate

Key Committee Memberships:

Quality Council

Quality Meeting

RELATIONSHIPS:

Manage the Quality System Executive

Interact on a daily basis with Products Portfolio Quality Manager

Interact on a daily basis Supply Coordinator

Requirements

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