Pharmaceutical Validation Expert

1 day ago


Dublin, Dublin City, Ireland beBeeValidation Full time €60,000 - €80,000

As a key player in our manufacturing operation, you will be responsible for ensuring that the validation activities associated with a Syringe Filling Line for a Sterile fill finish facility meet GMP and Quality Requirements.

Job Role:

You will oversee the generation, execution, review, and approval of CQV test documentation, including FAT, IVs, FTs, SAT, and PQs associated with a Syringe Filling Line. You will also pre-approve and post-approve validation protocols, input into site Validation Master Plans and SOPs, collate and report on relevant validation data/metrics, assist in exceptions and deviation resolution and root cause analysis.

Responsibilities include reviewing Validation planning documents detailing overall strategy for the project, reviewing and approving Qualification summary reports (QSR), generating Validation Summary reports, assisting in the development of User Requirement Specifications (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

Requirements:
  • 6+ years 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


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