Principal QA Validation Specialist

  • Location

    Limerick, Republic of Ireland

  • Sector:

    Quality, Engineering , Science

  • Job type:


  • Salary:


  • Contact:

    Justin Pankinas

  • Contact email:

  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


Summary: Validate/qualify site computerised systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Essential Duties and Responsibilities include, but are not limited to, the following:

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.

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

May manage full time employees and/or contingent workers.

Performs other duties assigned by Management.

Some travel may be required.

Education and Experience:

BS/BA in Engineering, Chemistry, or Life Sciences with 8+ 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