QA Lead – QP Steriles

The Company

This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and now boasts 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 meet 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 delivering access in the future for patients. Due to continued expansion, an exciting new position has arisen in the organisation for an QA Lead – QP (Steriles) to join their growing Quality team in Dublin.

The Position:

The QA Lead – QP (Steriles) will act as a Qualified Person (QP) named on the organisations manufacturing and Import Authorisation (MIA) licence under the direction of the Head QP, performing EU QP release and associated QP Good Manufacturing Practice (GMP) activities with responsibility for the organisations finished dosages in accordance with their Marketing Authorisations. As the successful QA Lead – QP (Steriles), you will be responsible for:

  • Certifying that batches of finished product to be released by the busness and providers on the EC/EEA, have been manufactured and checked in accordance with the Marketing Authorisation, the Manufacturing Authorisation, GMP and legal requirements as set out in Article 51 of directive 2001/83/EC.
  • Investigating any quality related deviations and support execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained

The Person:

  • Degree in Science or Science related discipline
  • Quality experiene in a parentaeral/biotech manufacturing operation including experience gain in aseptic/sterile processing.
  • Must be eligible to act as a QP – ideally experience gain releasing batch.

To learn more apply on line or call Shane Browne on +353 1 6321865.

Salary: On Application Location: Dublin West