Artwork & Labeling Quality Specialist

Artwork & Labeling Quality Specialist

This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, they have expanded rapidly in their short history and now boast more than 10,000 employees, and offices in more than 40 countries. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to serve significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today, and building their pipeline through research and development and business development to deliver future treatment access for patients. Due to continued expansion, this organisation is now looking for a Artwork & Labelling Quality Specialist to join their operation in Dublin.

The Position:

  • Support/oversee the artwork management/labelling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor.
  • Prepare, review and coordinate artworks for marketing authorisation applications, variations, renewals etc.
  • Support resolution on areas identified as non-conformance related to his/her area(s) of expertise, as requested
  • Checking the compliance of artworks with technical and in-country registration requirements.

The Person:

  • A Science degree or related.
  • The ideal candidate will have approx. 2 years in pharmaceutical manufacturing/quality operations
  • Packaging and labelling experience is desirable.
  • General knowledge of FDA regulations and GxPs
  • Be detailed oriented, meet deadlines, and have good communication skills

To learn more apply on line or call Ciara O’Brien directly on +353 1 6321855.

Salary: On Application Location: Dublin West