Cache of job #13767465

Job Title

Senior QA Validation Specialist

Employer

Harmonics Recruitment

Location

Clare, Limerick

Description

Offering a fantastic opportunity to work within a Global Multinational in Limerick. Including fantastic benefits and salary. Implements policies and procedures to validate/qualify equipment, systems (inclusive of Continuing, CSV, Cleaning Val/SIP), and processes in accordance with regulatory requirements and company manufacturing standards. Responsibilities. 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. 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 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. 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 6+years of related experience within the field preferred; will substitute relevant experience for education. For more information on this role or any other roles, please contact Rachael O` Rourke on 061 336136. This job originally appeared on RecruitIreland.com.

Date Added

2466 days ago

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