
Pharmaceutical Validation Professional
1 semana atrás
The successful candidate will be responsible for supporting several aspects of validation in our regulatory environment.
- Key Responsibilities:
- Design, author, review, and approve qualification/validation documentation and cycle development studies
- Execute the development of change controls
- Resolving technical issues encountered during study execution
- Engagement with Production, Maintenance, and Quality representatives in assigned areas of operations during execution of Cycle Development & Performance Qualification activities
- Relevant technical qualifications in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification
- Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills
- Exception/Deviation Management and Change Control experience
- Leading technical related projects and knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System)
- Continuous professional development, regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices
- Ability to analyze and interpret complex data, link to equipment performance and out-of-specification findings as appropriate
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