Quality Assurance Specialist – Shannon
Are you an experienced Quality Assurance Specialist looking for a new opportunity in a cutting-edge biopharmaceutical environment? We are hiring for a leading organisation in advanced therapies and gene therapy manufacturing in Ireland. This is a fantastic opportunity to contribute to the design, build, qualification, and operation of a state-of-the-art facility.
About the Role
As a QA Specialist, you will provide quality oversight and compliance support to manufacturing and laboratory activities. You will play a key role in implementing and improving the Quality Management System (QMS), ensuring regulatory compliance with EU, Irish, and FDA cGxP requirements. This role involves regular interaction with manufacturing teams, supplier qualification, and occasional travel.
Key Responsibilities
- Quality oversight of manufacturing activities to ensure compliance with all regulatory and company quality standards.
- Review and approval of quality documentation, including deviations, CAPAs, change controls, SOPs, risk assessments, and temperature logs.
- Conduct routine facility walk-throughs, including entry into sterile areas, to proactively identify and mitigate compliance risks.
- Perform internal self-inspections and external audits of key suppliers and service providers.
- Assist in preparation, execution, and follow-up of regulatory inspections and audits.
- Deliver GxP compliance training to operational teams.
- Drive improvements in the QMS, ensuring compliance with industry best practices and regulatory expectations.
About You
- Minimum five years' experience in a GMP-regulated Quality Assurance role within biotechnology, pharmaceuticals, or advanced therapies.
- Strong understanding of QMS, investigations, change controls, CAPAs, and regulatory audits.
- Experience in conducting internal and external audits.
- Knowledge of eQMS systems and proficiency in Microsoft Office.
- Excellent attention to detail, communication, and organisational skills.
- Ability to work both independently and collaboratively within a fast-paced environment.
- Experience with Competent Authority or Regulatory Body inspections is highly desirable.
If you’re ready to take the next step in your Quality Assurance career, apply now!
Apply today – don’t miss this opportunity to be part of an innovative and growing team!
