QA Specialist

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.

• 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.

Candidate must be eligible to work in the EU