QA Validation Specialist – Cleaning required for a leading pharmaceutical company based in Limerick. This is a permanent, fulltime position, offering an excellent salary and benefits

Job Summary

Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Responsibilities :

• 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.
  

• 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