New role in the West of Ireland, fantastic opportunity with a great company.
- Responsible for the drafting, executing & reporting of all validation activities including but not limited to (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
- Participate in Validation/Qualification projects across a range of production areas which may include Sterilisation, Filling, Process, Cleaning, Software, Utility and Facility projects.
- Generate, execute and close out on validation projects relating to existing products and new product introductions.
- Participate in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
- Conduct process validation against Corporate SOP/FDA/EMEA requirements.
- Analyse statistical data to determine process capability.
- Execute and document process risk assessment / failure mode and effects analysis.
- Perform validation functional testing as required.
- Track and resolve exceptions during qualification activities.
- Minimum of a Bachelor's Degree in a Technical, Science, Production or Process discipline and 3-6 years’ experience in a validation role within the pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.
- Must possess knowledge of pharmaceutical and medical device regulatory requirement for FDA and IMB regulated environments.
- Knowledge of Pharma/Medical product manufacturing, especially sterilisation processes and/or filling operations.
- Experience in process, software, filling and sterilisation process validation.
- Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.
- Experience with statistical software packages.
For more information please call me on 091 507507 or Annemarie.email@example.com