Our client, a leading pharmaceutical company based in Limerick has a requirement for a QA Validation Specialist - QC. This is a permanent, full-time position offering an excellent salary and benefits package.


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 :

• Generates, executes, reviews, and approves master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• 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.
• Initiates, reviews, edits and approves change control and SOPs
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education.
• Ability to comprehend regulatory requirements and technical documentation
• Working knowledge of Microsoft Office Suite and LIMs.
• Familiarity with qualification requirements for QC laboratory equipment such as HPLC, pH meter, conductivity analyzer, balances.