Description
C&Q engineer to work on the automated inspection machine for a 6 month back fill role near Dublin.Responsibilities
* Close out of SAT
* Vision characterisation testing
* Execute PQ
* Development of Validation Plans •
* Ensure all aspects of Validation adhere to required policies and procedures, including safety and training. •
* Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. •
* Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
* Participate as required in project activities. •
* Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed. •
* Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations.
* Input to Site Validation Guidance Documents •
* Collate and report on relevant Validation data/matrices. •
* Assist in deviation and exception resolution and root cause analysis. •
* Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
Experience/Background •
* A third level qualification in Science, Engineering or a relevant Quality discipline. •
* Minimum 4-6 years’ experience in a similar role.
Education Requirements •
* A third level qualification in Science, Engineering or a relevant Quality discipline.
If this is you please apply today.