Quality and Compliance Professional

Our client are a Global healthcare company who develop, manufacture and distribute both branded Pharmaceutical and Biological products across a variety of therapeutic areas. They employ 6,500 staff, have several R&D and manufacturing sites worldwide and are set to generate a revenue of approximately €2 billion this year. There is a requirement for an experienced Quality professional to join their established operation in Dublin which acts as a local commercial affiliate for the business.

The Role

As a Quality expert for the site, you will be accountable for the following:

  • To develop, manage and optimise the local Quality Management System to ensure compliance with corporate, regulatory and legal requirements
  • The management of complaints, recalls/mock recalls, deviations, returns, change control for the local affiliate and ensure compliance with Good Distribution Practice requirements (GDP)
  • To perform local product release of distributed goods
  • To oversee and manage the supply of product
  • To support Pharmacovigilance – performing role of Local Safety Officer for the affiliate and ensure timely compliance with legal reporting requirements
  • The management of Technical Agreements and Safety Data Exchange Agreements
  • To perform the role of Privacy Champion, providing guidance and ensuring that the local affiliate is in compliance with the EU’s General Data Protection Regulation

The Person

In order to be considered you must have the following:

  • A BSc or equivalent in Science or related
  • 4-8 years’ industry experience working within Quality or Compliance within the Pharmaceutical sector
  • Knowledge of Quality Management Systems and EU regulations
  • Excellent project management experience and communication skills
  • Experience working to GDP standards (experience dealing with vendors / suppliers / distributors and working closely with supply chain from a quality perspective)
  • Experience as a Deputy Responsible Person (RP) would offer you a distinct advantage but is not essential

To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on +353 1 6321827 for a confidential discussion.

Salary: On Application Location: Dublin West