Qualified Person (QP)

This global biopharma company is undergoing steady expansion and offer good career progression opportunities in a thriving environment where internal promotion is fully supported. The QP will have QA oversight of all activities in the pharmaceutical business unit. The QP will hold responsibility for certifying all batches manufactured in the business unit against the requirements of marketing authorisation and the principles of GMP. This role will report to the Director of QA.

The Position

  • Part of your role will be to provide direction to all quality personnel based in the pharma unit, including QC, product release, and compliance.
  • As QP you will be involved in business strategy, you will liaise with the Director of QA and Business Unit Leader and assist in setting the deliverables of the quality plan and global regulatory requirements.
  • You will approve all records generated by this department, including; batch records, laboratory certificates of analysis, deviations, validation documents and product quality review reports.
  • You will provide guidance on all non-conforming material/deviated batches.
  • You will be responsible for directing the investigation and determining the release disposition of material/product.
  • You will be a Quality Representative in meetings relating to Quality Management & Senior Management review meetings.
  • You will report at meetings relating to QMS: deviation investigations & Change Control Review Board.

The Person

  • You will have experience working in a similar role in a pharmaceutical company.
  • You must have a degree in a Pharmaceutical Science or similar and a recognised QP qualification.

For more information apply now or call Kristine Reynolds on + 00353 91782112

Salary: On Application Location: Mayo