Job Title:
Quality Assurance Specialist
Job Description:
This position is an integral part of the Quality Assurance team based in Ireland. The Quality Assurance Specialist will be responsible for delivering quality assurance activities to ensure products are manufactured according to Good Manufacturing Practices (GMP) and regulatory requirements.
The role involves reviewing and approving validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and ongoing manufacturing. This key role is an individual contributor role that requires a self-starter with professional and academic experience in quality assurance and validation activities. The specialist must ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering, and Technical Services.
Required Skills and Qualifications
* Third-level qualification in a relevant science and/or engineering discipline
* 5 years minimum experience working in a GMP quality environment
* Experience in a validation function with strong knowledge of project life cycle and cGMP regulations
Benefits
We offer a competitive benefits package. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other protected characteristics.
Others
The QA Specialist will work closely with cross-functional teams to drive continuous improvement and ensure compliance with GMP and regulatory requirements.
Key Responsibilities:
1. Site QA point of contact providing technical expertise, feedback, and guidance for QA and compliance topics/issues, including validation strategy/approach, new product introduction, and manufacturing, and assist in the resolution of issues commensurate with the level of risk.
2. Manage assigned areas of the Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
3. Generate, review, and approve SOPs/other documentation as applicable to your areas of responsibility.
4. Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
5. Review and approval of validation protocols/reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures.