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Details

QA Validation Manager


Reference:A005730 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

QA Validation Manager
Our client, a large biopharmaceutical organisation are currently recruiting for a QA Validation Manager to join their team on a permanent basis. As QA Validation Manager you will be responsible for implementing policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and the organisations manufacturing standards, and will manager a team of Validation Specialists.

Responsibilities
• Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation
• Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines
• Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks
• Lead technical and quality investigations
• Collaborates with functional departments to resolve issues
• Manage a cross-functional projects with many stakeholders
• Review, edit and approve change controls, SOPs, reports and other documentation
• Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Review, edit and approves deviation notifications, deviation investigations, and corrective actions
• Trains/advises less experienced Specialists
• May present at both internal and external (regulatory) audits if required
• Stays current with industry trends, regulatory requirement updates, and communicating same to team

Requirements
• BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; may substitute relevant experience for education
• Previous team/people management experience essential
• Previous cleaning validation and steam in place experience an advantage
• Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage


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

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