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Principal QA Validation Specialist

Location: Limerick
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Principal QA Validation Specialist
Our client, a large biopharmaceutical organisation are currently recruiting for a Principal QA Validation Specialist. As Principal QA Validation Specialist you will be responsible for the validation and qualification of equipment, systems, and processes in accordance with regulatory requirements.

• Generates, execute and review 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
• Investigate and troubleshoot problems which occur and determines solutions or recommendations for changes and/or improvements
• Review, edit and approve deviation notifications, deviation investigations, and corrective actions
• Review, edit and approve change controls, SOPs, reports and other documentation
• Coordinate with other departments or outside contractors/vendors to complete validation tasks
• Collaborate with functional departments to resolve issues
• Train and 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
• May present at both internal and external (regulatory) audits
• Stays current with industry trends, regulatory requirement updates, and communicating same to team

• BS/BA in Engineering, Chemistry, or Life Sciences
• 8+ years of related experience within Validation
• Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred
• Experience in the review & approval of Validation documentation essential

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


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