QA Specialist
- Dún Laoghaire, Co Dublin
- Permanent
- Full-time
- Act as the Quality point of contact and decision-maker during New Product Introductions, Technology Transfers, and Process Validation activities for aseptic products, ensuring full compliance with regulatory expectations.
- Review and approve Process Development and Validation documentation, including technical transfer documents, validation protocols, and executed reports.
- Provide Quality direction and input at Change Control and Deviation Review Boards, maintaining QA oversight of all change control and Deviation/CAPA records.
- Ensure all records are clearly scoped, with timely and robust implementation of activities.
- Perform all responsibilities in strict compliance with the clients safety standards, procedures, and SOPs.
- Support continuous improvement by collaborating across cross-functional teams and adapting responsibilities in line with evolving business needs.
- 7+ years in a QA or validation-focused role within the pharma/biotech sector
- A degree in Science or Engineering (preferred)
- Deep understanding of Validation, NPI, and aseptic manufacturing
- Proven ability to lead within Deviation/CAPA/Change Control processes
- Strong critical thinking and cross-functional communication skills
- Comfortable working independently and remotely
- A team-oriented mindset, with confidence to challenge and collaborate