Limerick Validation Specialist
The Validation Specialist will work under the direction of the Validation Team Supervisor and will join a team of technicians and specialists.
His/her principal assignments are to develop test protocols for automated vision solutions as well as validation protocols (FAT, SAT, IOQ) and to participate in the development of material test protocols. Working in constant interaction with the development and production teams, and apply creativity into developing test strategies.
- Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project
- Responsible for authoring GAMP documents including Design Risk Assessments, Traceability Matrices and validation protocols (FAT,IQ,OQ) to GAMP5 standards
- Maintain validation procedures and keep templates up to date, focusing on continuous improvement
- Provides input on other validation projects by critiquing, editing, and proofreading documentation prepared by others
- Provide support and assistance to customers including site visits to advise on execution of protocols
- Development of training materials as needed
- Co-ordinate validation documentation review and approval
- Periodically conduct training sessions on documentation standards and other topics
- Preform requirement analysis and liaise with engineering departments to ensure design documentation meets customer requirements and adheres to internal standards
- Responsible for re-engineering documents to meet current specifications and good documentation practices
- Third Level Degree in Engineering or relevant discipline, preferably with Packaging/Pharma Background
- At Least Minimum of 2-3 years Technical authoring of Validation documentation experience preferably within a GAMP regulated industry
- Strong Knowledge of Regulatory requirements and structured standards and practices – FDA ¦ GAMP ¦ 21CFR11 FDA ¦ GAMP