Principal QA Validation Specialist opportunity in Limerick.
This is a permanent position with a top multinational. attractive salary and benefits package on offer for the successful candidate.
The Principal QA Validation Specialist will Validate/qualify site computerised systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
Role of this position
- 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
- Analyses 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.
- Collaborates with functional departments to resolve issues. Trains/advises less experienced Specialists.
- Manage and drives projects and prepares status reports.
- May manage full time employees and/or contingent workers and supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
- BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; may substitute relevant experience for education.
- Experience with qualification of IT Enterprise systems or MES PAS-X would be an advantage.
- Experience of implementing systems in accordance with 21CFR Part 11 regulations i.e. Electronic Sigs & Electronic Records which also leads on to data Integrity & Audit Trail review.
- Project management experience will be an advantage.
Please call Michelle Galvin today for further information on 091 373 938 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)