Quality Assurance Role Overview
The Quality Assurance Specialist will be responsible for ensuring the highest quality of products manufactured at our site.
This includes compliance with EU Guidelines for Good Manufacturing Practice and certification by a Qualified Person.
Key Responsibilities:
* Ensure that each individual batch has been manufactured and checked in accordance with laws in force, in accordance with the requirements of the Product Specification File (PSF) / Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP).
* Disposition of bulk product manufactured as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
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.
* 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.