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Senior QA Validation Specialist - Cleaning Validation

Reference:POR287078
Location: Limerick
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: EHS Specialist, Validation Specialist

A Senior QA Validation Specialist – Cleaning Validation is required to join a rapidly expanding Biopharmaceutical organisation in Limerick. The key focus of the role is to schedule, execute and review Continuing Qualification activities for large and small equipment in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

The role

  • Assess executed change controls and deviations for impact to the Qualified state for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Schedule, execute and review Continuing Qualification activities for large and small equipment
  • 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
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • 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.
  • Some travel may be required.

The Person

  • BS/BA in Engineering, Chemistry, or Life Sciences
  • 5+ years of Cleaning Validation experience gained within the Life Sciences industry sector
  • Strong Quality background and familiar with Site change controls in general.
  • Experienced in reviewing, editing and approving change controls, SOPs, reports and other documentation
  • Proven experience of and implementing company manufacturing standards policies and procedures

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie




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