QA Specialist
- Sligo
- Contract
- Full-time
- Join an experienced team and work on exciting, high-impact projects in a dynamic and collaborative environment.
- QA point of contact providing technical expertise, feedback and guidance for QA and compliance
manufacturing and assist in the resolution of issues commensurate with the level of risk. * Perform timely review and approval of site procedures and documentation to ensurecompliance with GMP and regulatory requirements. * Review and approval of validation protocols/ reports and related documentation to ensurecompliance with current EU regulatory expectations and site procedures. * Ensure schedules for review and approval of GMP /validation documents are maintained tosupport technology transfers and new product introduction project timelines. * Ensure application of Quality Risk Management principles as applicable.
- Act as the QA in QA activities in project work-streams involving cross-functional,
and others. * Actively contribute to continuous improvement activities.
- Other duties as assigned.
- Strong understanding of GMP compliance and quality standards
- Excellent attention to detail and significant document review experience essential
- Effective time management and multi-tasking skills
- Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail
- Excellent communication skills, both verbal & written.
- Proficient in written and spoken English
- Collaborative Team Player Essential Education and Experience:
- Third level qualification in relevant science and/or engineering discipline
- 5 years minimum experience working in a in a GMP Quality environment.
- Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations.