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ASEPTIC PROCESS VALIDATION EXPERT
2 weeks ago
A Validation Engineer is required for a pharmaceutical client based in Waterford, Ireland. The successful candidate will be responsible for designing, executing and reporting on PV/Process Performance Qualifications, as well as providing technical interpretation and guidance of current US FDA and EU validation requirements.
Required Skills and Qualifications- Degree in Science (Chemistry, Microbiology or Pharmacy preferred)
- Previous validation/product development experience would be highly advantageous
- Knowledge of Process Validation regulations, current process validation and technical transfer industry practices
- Ability to execute projects to plan and good knowledge of quality management systems
This is a 12-month contract position offering the opportunity to work with a reputable pharmaceutical company in Waterford. The role requires a strong understanding of relevant quality and compliance regulations and the ability to provide technical interpretation and guidance.
OthersThe ideal candidate will have excellent communication skills and be able to work effectively in a team environment. They will also have a full understanding of GAMP, ISPE Baseline guides, AAMI/ANSI, PDA and ISO guidelines.