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Details

Validation Specialist


Reference:AQSG-614211cc Location: Dublin
Dublin West
Republic of Ireland
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed

Job Title: Validation Specialist
JOB PURPOSE
Our client is a large pharmaceutical company based in Dublin. An opportunity has arisen within the Technical Department for the position of Validation Engineer. This person will be responsible for writing and executing validation protocols and reports within the required timelines and in compliance with Regulatory and cGMP guidelines.

KEY TASKS AND 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.

SKILLS, EXPERIENCE AND QUALIFICATIONS

  • 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




Clodagh Nerney | Tel: +353 (0) 1 507 9254





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