QA Validation Specialist – Cleaning required for a leading pharmaceutical company based in Limerick. This is a permanent, full-time position, offering an excellent salary and benefits
Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures
Responsible for all aspects of the Cleaning Validation programs onsite for a large scale Biopharmaceutical production facility.
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.
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 controls, SOPs, reports and other documentation.
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
8+ years of related experience within the field of Cleaning Validation in Biopharmaceutical, Aseptic Fill/Finish or API manufacturing
For more information on this position or any other technical position please contact Melissa Foley on 061 336 136