Sr Validation Specialist

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: SVS040119
  • Date Posted January 4, 2019

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.

Essential Duties:

  • 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

More Details

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

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