Advanced Quality Assurance Professional

9 hours ago

Shannon, Ireland beBeeQuality Full time €95,000 - €118,000
Senior Quality Assurance Specialist Job Description

The purpose of this role is to provide QA support and oversight for the Irish Manufacturing site during facility design, build and qualification for the manufacture and supply of clinical and commercial advance therapies medicinal products.

This will involve ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, QMS and any other applicable regulations/standards.

  • Providing QA review and approval of quality documentation generated in Irish operations.
  • Supporting a "Quality on the Shop Floor" culture through completion of facility walk rounds.
  • Generating and preparing quality documents such as SOPs and controlled documents.
  • Ensuring compliant and adequate systems are in place to monitor investigations, CAPAs, audits and Quality Review Boards.

Key responsibilities include:

Job Objectives

To deliver high-quality products that meet customer needs and expectations while ensuring compliance with regulatory requirements.

Key Performance Indicators (KPIs):

  • Delivery of products that meet customer needs and expectations.
  • Compliance with regulatory requirements.
  • Effective management of investigations, CAPAs and audits.

Required Skills and Qualifications

  • 10 years of experience working in a GMP regulated environment, biotechnology or related manufacturing.
  • Experience in the operation and improvement of all aspects of a local QMS including investigations, change controls and CAPAs.
  • Positive attitude with demonstrated flexibility to adapt to the needs of the department/wider business.
  • Ability to identify and escalate issues to line management.
  • Experienced in performing internal and/or external audits.

Benefits

This role offers a unique opportunity to work in a dynamic and fast-paced environment with a focus on delivering high-quality products. The successful candidate will have the opportunity to develop their skills and knowledge in a supportive and collaborative team environment.

How to Apply

If you are a motivated and experienced individual looking for a new challenge, please submit your application.

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