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