Quality Assurance Specialist/QP

Collins McNicholas Recruitment; Sligo; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading recruitment agency is seeking an experienced Quality Assurance Specialist/QP to join a pharmaceutical company in Sligo. This 12-month contract role requires a third level qualification in a science discipline and significant experience in the pharmaceutical industry, including expertise in regulatory compliance and GMP. Interested candidates should contact Emma Daly at the provided email.

Qualifications

• 5 years' experience in the pharmaceutical industry.
• 2 years’ experience in an aseptic processing environment.
• Experience in an FDA and EMEA approved pharmaceutical environment.

Responsibilities

• Comply with EU Guidelines for Good Manufacturing Practice.
• Ensure compliance with laws for product certification.
• Responsible for the disposition of bulk product.

Skills

Quality Assurance

Regulatory Compliance

Batch Release

Good Manufacturing Practices

Aseptic Processing

Education

Third level qualification in a science discipline

MSc in Industrial Pharmaceutical Science

Job description

Overview

Our client, a leader in the pharmaceutical industry, is seeking a Quality Assurance Specialist/QP to join their team in their Sligo facility. This is a 12-month contract.

Responsibilities

• 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.
• Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured at AbbVie Biologics Ballytivnan Sligo.
• To ensure that products manufactured at AbbVie Biologics Ballytivnan Sligo are manufactured in accordance with the relevant GMPs.
• The Quality Assurance Specialist / Qualified Person (QP) is 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.
• To 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.

Qualifications

• 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.

For a confidential discussion and more information on the role, please contact Emma Daly

[e-mail]

0861041202