Senior QA Specialist
Cork
Contract
Hybrid
Hybrid
QA Validation Specialist
Role Overview
Role Overview
- Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Oversees cleaning validation for program to ensure program adherence in accordance with approved schedules.
- 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.
- Effectively communicate to key stakeholders on the validation programs (program adherence, success rate, issues / roadblock).
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Other duties assigned by management.
- 5+ Years experience working in cleanroom validation
- Experience of environmental monitoring
- Ability to travel to Cork on occasion