Overview
The role would be for a QC equipment validation Specialist role, specifically involving the full qualification of a bench top Near-Infrared (NIR) spectrometer.
The managers specifically want someone at a senior level that can take full ownership of the project, ensuring timelines and schedules are met.
The scope of work would include, but is not limited to:
URS (User Requirements Specification) documentation
GxP compliance assessment
Change control management
Support for Vendor IQ/OQ activities
NIR model development
Performance Qualification (PQ)
RTM (Requirements Traceability Matrix)
Annex 11 compliance
Validation Summary Report
Qualifications
Degree in Science, Quality, or a related Technical field.
Experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Lab function
Strong experience with validating lab equipment
Strong written and verbal communication skills
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on ********** or alternatively send an up to date CV to ******
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland
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