Licence to Operate (LtO) Coordinator

Job description

·  Job facts

In an Organisation with big ambition, there is opportunity to make meaningful change a reality. We have a vacancy for a full time office based Licence to Operate Coordinator.

This is a specified purpose contract to support cover for a Maternity Leave. The successful person will report to the Head of Licence to Operate and will support and perform activities to enhance the skill centre's effectiveness and efficiency, including ongoing compliance with applicable regulations.

The Licence to Operate (LtO) Coordinator's key operational activities will include:

·  Performing tasks in support of Licence to Operate (LtO) processes across the related functional areas of Regulatory, Quality, Pharmacovigilance and Compliance.
·  Assist with internal and external facing LtO related initiatives.
·  Collaborate with Subject Matter Experts in the development of guidelines and procedures.
·  Provide general support/back-up where required within the LtO team.
·  Coordinate projects and initiatives.
·  Proactively identify and evolve areas of continuous improvement.
·  Collaborate with other departments to create a culture of compliance.
·  QC checking of LtO records.
·  Coordination support for the Service Provider Management program.

Person/Skills Profile

·  BSc (life sciences/health sciences degree) or equivalent.
·  A knowledge of GxP and relevant EU and HPRA requirements.
·  Demonstrates core competencies.
·  Managing/Coordinating multiple projects
·  Excellent computer skills

Closing date 3rd February 2021

·  Who we are

Roche Products (Ireland) Limited was established as a full affiliate of F. Hoffman-La Roche. The company is based in Citywest in Dublin 24, and deals with the commercial aspects of our Irish business, including sales and marketing, finance, regulatory and medical affairs for the Pharmaceutical Division.

Roche is an equal opportunity employer.