A Senior QA Validation Specialist (Cleaning Validation) is required by CareerWise Recruitment for our Limerick based client.
Continuing Qualification activities for equipment in accordance with regulatory requirements and company manufacturing standards
Role of this position
- Strong Quality background and familiar with Site change controls in general.
- Assess executed change controls and deviations for impact to the Qualified state for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Schedule, execute and review Continuing Qualification activities for large and small equipment
- 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.
- Collaborates with functional departments to resolve issues.
- Trains/advises less experienced Specialists.
- May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
- Manage and drives projects and prepares status reports.
CareerWise Recruitment (In Search of Excellence)
- BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred.