QA Specialist
Job Type | Contractor |
Area | Sligo, Ireland |
Sector | EngineeringQuality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | 3656 |
Job Views | 145 |
- Description
Team Horizon is seeking a QA Specialist for a 12-month contract to support a number of exciting projects at our client’s manufacturing facility in the North West.
Why you should apply:
- Join an experienced team and work on exciting, high-impact projects in a dynamic and collaborative environment.
What you will be doing:
- 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. - Perform timely review and approval of site procedures and documentation to ensure
compliance with GMP and regulatory requirements. - Review and approval of validation protocols/ reports and related documentation to ensure
compliance with current EU regulatory expectations and site procedures. - Ensure schedules for review and approval of GMP /validation documents are maintained to
support 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,
multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering,
and others. - Actively contribute to continuous improvement activities.
- Other duties as assigned.
What you need to apply:
- 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.