QA Validation Specialist - QC
Harmonics Recruitment
Clare, Limerick
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. Knowledge and Skills: 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. For more information on this position please call Lee-Ann Enright on 061 336136 or alternatively apply online now and a member of the Harmonics team will be in touch. This job originally appeared on RecruitIreland.com.
2379 days ago