We are seeking a Quality Assurance Specialist to join our team at Collins McNicholas. The ideal candidate will have a third-level qualification in a science discipline and 5 years' experience in the pharmaceutical industry.
Key Responsibilities
* Comply with EU guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.
* Ensure that products manufactured at our facility are manufactured in accordance with relevant GMPs.
* Disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.
Requirements
* Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
* MSC in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
* 5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
* 2 Years' experience gained within an aseptic processing environment, ideally gained within a quality function.