Job Overview:
The Quality Assurance Specialist will be responsible for ensuring that the validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and quality requirements.
This includes generation, execution, review, and approval of CQV test documentation (FAT, IV's, FT's, SAT, and PQ's) associated with a Syringe Filling Line.
About the Role:
* Ensure validation activities meet regulatory requirements
* Collaborate with cross-functional teams to develop and implement validation strategies
* Review and approve test documentation to ensure accuracy and completeness
This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.
Requirements:
To succeed in this role, you will need:
* 6+ years of experience in engineering or validation
* Technical qualification at third level or equivalent in engineering
* Extensive knowledge and demonstrated experience executing validation activities for pharmaceutical/biotechnology projects
Benefits:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.