QA - Validation Specialist

3 weeks ago


Sligo, Sligo, Ireland Cpl Full time

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Senior Talent Partner at CPL - Science & Engineering : 01 614 6178

JO-2506-552925

QA Validation Specialist required for expanding biotech site in Sligo town. The successful candidate will have prior Validation experience in equipment, facilities and utilities in a GMP environment.

Get in touch with me for further information : Deirdre Murphy on 01 614 6178 / 087 180 4358 or [email protected]

  • Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
  • Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
  • Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
  • QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
  • Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
  • Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
  • Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
  • Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA
  • Act as the QA lead in QA activities in project work-streams involving cross-functional, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
  • Actively contribute to continuous improvement activities.

Seniority level
  • Seniority levelEntry level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesStaffing and Recruiting

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