Pharmaceutical Validation Specialist

5 days ago


Waterford, Waterford, Ireland TN Ireland Full time
Job Description

A Pharmaceutical Validation Specialist is required for a 12 month contracting position at our client's Waterford site. This role involves the validation of new equipment, processes, and control systems.

Key Responsibilities
  1. Develop and execute DQ, IQ, OQ, and PQ activities to ensure compliance with cGMP.
  2. Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing, and sterilization.
  3. Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
  4. Review and approval of site change controls.
Requirements
  • Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
  • 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • 2-3 years experience in validation environment.
  • Knowledge of requirements for GAMP, ISPE Baseline guide desirable.
  • Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines desirable.


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