Senior Quality Officer
DescriptionThe 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:
Manage the Quality System Executive
Interact on a daily basis with Products Portfolio Quality Manager
Interact on a daily basis Supply Coordinator
- A scientific degree is essential
- A minimum of 5 years experience in quality system management
- An good knowledge of GMP
- A knowledge of ISO 9001 and ISO13485 will be appreciated
- Experience in auditing in GMP ISO environments
- Experience with regulatory inspections and ISO audit
- Able to make data driven recommendation/decisions and take appropriate action;
- Strong analytical, organisational and problem-solving skills;
- Ability to present effectively to groups
- Strong influencing skills and negotiation skills
- A leader, quality champion and team player