Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for a Sr Validation Specialist – Cold Chain to join their expanding team. This is a full-time, permanent position offering an excellent salary and benefits package.
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.
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 improvement
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 position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch