QP – Biologics / Steriles

Our client is one of the world’s leading biopharmaceutical companies having expanded rapidly in its short history, they now boast more than 5,000 employees and have offices in more than 40 countries. Part of a fortune 500 organisation, this company has grown due to an innovative internal development pipeline and an aggressive acquisition strategy. To support this consistent growth, the Quality department seeks a new QP to join the team on an initial 11 month FTC.

The Role:

Reporting to the Head of Disposition for External Biologics, as QP you will work in the Disposition Team of the External Biologics Quality Organisation and will be based in Dublin. This team is responsible for biological material disposition, including QP certification of material manufactured at contract manufacturing organisations on behalf of the company, including those imported from Third Countries.

The Person:

In order to be considered for this role you must have the following:

  • BSc / BA / MSc in science or related discipline
  • Eligible to work as a Qualified Person meeting the requirements of Article 49 of Directive 2001/83/EC of the European Parliament, as amended
  • 8+ years’ experience working in Quality Assurance with proven experience working as a Qualified Person performing disposition of sterile medicinal products or biological medicinal products
  • Thorough understanding of quality systems, EU GMP and GDP and US Code of Federal Regulations Title 21, Part 210 and 211
  • Eligibility to work in the EU
  • Flexibility around domestic and international travel (15%)

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 City Centre