Compliance Officer
Braunton, GB, EX33 2DL
Description Overview
To provide site support to maintain compliance with product registrations, including the existing product portfolio, new product introductions and technical transfers.
Scope of the Role
- Review of site documentation to ensure alignment with dossiers as required
- Managing the review of compliance gaps and coordinating closure in a timely manner
- Effective management of Contract Giver dossiers
- Supporting technical transfers and new product introductions with respect to the regulatory strategy agreed
- Support product and process improvements with respect to the impact on the product licence
- Coordination of the supply of data and information to support regulatory submissions and variations.
- To undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.
Experience Required
- Educated to degree level or equivalent in a relevant scientific discipline
- Experience of working within Quality Assurance or Regulatory Affairs departments within the pharmaceutical industry
- Project management experience is desirable
- Must be able to self-manage, have excellent organisational and time management skills whilst working on multiple projects concurrently, and be able to prioritise effectively in order to achieve required deadlines
- Good communication and influencing skills with all personnel at all levels of the organisation
- Computer literate
- High level of accuracy and an eye for detail
- Confident working as part of a multi-disciplinary team, including those with people from different levels of the organisation
- Good interpersonal skills; effective team player