Quality Assurance Specialist/QP

Description

• Responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
• Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force.
• To ensure that products manufactured by the client are manufactured in accordance with the relevant GMPs.

Requirements

• Comply with EudraLex Volume 4 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.
• Extensive experience gained within an aseptic processing environment, ideally gained within a quality function.
• Third level qualification in a science discipline with extensive experience in the pharmaceutical industry.
• Extensive industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
• MSc in Industrial Pharmaceutical Science or similar course recognised by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance