Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for a QA Validation Specialist to join their team. This is a 12 month contract initially offering a competitive salary and the chance to join a market leading team.
Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures
Essential Duties and Responsibilities include, but are not limited to, the following:
- Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Trains/advises less experienced Specialists.
- Manages projects and prepares status reports.
- May be required to oversee contingent workers.
- Performs other duties assigned by Management.
- Some travel may be required.
Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences
- Associate Specialist 0-2 years
- Specialist level 2-5+ years
- Sr Specialist 5+ years