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Ref: 8380BR_1482333305

QA Validation Specialist

  • Limerick
  • See description
  • Permanent full-time
  • Updated 11/01/2017
  • Regeneron Pharmaceuticals
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Description

Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.

 

Summary: Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
- Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
- Analyzes 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 control and SOPs.
- Collaborates with functional departments to resolve issues.
- May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department.
- May train/advise less experienced Specialists and Technicians.
- May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation within Regeneron SOPs.
- Manages projects and prepares status reports.
- Interacts with Automation/Process Engineering for managing changes during qualification window.
- Strong communication/presentation skills during internal/external audits.

Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences with 4+ years of related experience within the field preferred; will substitute relevant experience for education.



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Regeneron Ireland

Regeneron Ireland

 

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