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Details

Validation Specialist


Reference:AIYG-821561 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Validation Specialist
Our client, a global pharmaceutical company based in Dublin are currently recruiting for a Validation Specialist to join their team on a permanent basis. The Validation Specialist will be part of the Technical Department and will report directly into the Validation Manager.

Responsibilities
• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP)
• Validation/Qualification projects will be across a range of production areas which may include Process, Cleaning, Software, Utility and Facility projects
• Generation, execution and close out of validation projects relating to existing products and new product introductions
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation
• Execution and documenting risk assessments (FMEA) with respect to validation activities
Perform validation functional testing as required.
• Track and resolve deviations during qualification activities

Requirements
• Bachelor's degree in Science, Engineering, Technology or a related discipline
• Minimum of 3 years’ experience as a validation engineer in a cGMP environment, preferably in an oral solid dose facility
• Full understanding of cGMP requirements including Annex 11 and Annex 15
• Effective technical writing skills
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills are essential
• Must be flexible and able to manage multiple priorities simultaneously
• Must take ownership of all task assigned and proactively see them through to conclusion

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252