Urgent Quality Assurance Specialist

4 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
Quality Assurance Specialist - Sligo, Ireland - 11-Month Contract

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence, employing more than 1000 people. They are looking to add to their team and require a Quality Assurance Specialist.

This is a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.

Role Summary

- Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
- Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
- Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow.
- Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
- Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, and MES documentation.

Qualifications & Education

- A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
- Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
- Strong report, standards, and policy writing skills.
- Experience with equipment and process validation.

If this role is of interest to you, please apply now

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