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Urgent! QA Validation Specialist Job Opening In Tipperary – Now Hiring Cpl

QA Validation Specialist



Job description

QA Validation Specialist

Location: Cashel, Co. Tipperary

Reports to: Senior Manager, QA Operations

Type: Full-time, Permanent

Summary

You’ll ensure all equipment, computerised systems, facilities, and utilities remain in a validated and compliant state.

You’ll work closely with production and engineering teams to maintain the qualified status of systems in line with regulatory requirements and company procedures.

Key Responsibilities

  • Review and approve Qualification and Requalification protocols (IQ, OQ, PQ) for equipment, systems, facilities, and utilities.
  • Review and contribute to User Requirement Specifications.
  • Support the execution of qualification and requalification activities, including walkdowns of drawings and areas.
  • Liaise with vendors where required, including participation in FATs.
  • Review and approve drawings, SOPs, and supporting documentation.
  • Coordinate communication with production and engineering to ensure timely completion of validation tasks.
  • Provide QA oversight and regulatory advice on qualification, including CSV and data integrity.
  • Support qualification of laboratory equipment, reviewing and approving protocols and reports.
  • Lead investigations into qualification-related deficiencies and implement corrective actions.
  • Generate and execute project validation plans and master validation plans.
  • Prepare and review policies and SOPs related to validation.
  • Review and approve calibration and preventive maintenance schedules and work orders.
  • Track and manage the annual validation and periodic requalification schedules.
  • Support risk assessments, studies, and investigations related to qualification.
  • Participate in internal and external audits (HPRA, FDA) and maintain audit readiness.
  • Promote continuous improvement in validation systems and manage KPIs for management review.
  • Support internal self-inspections and maintain validation documentation and archives.
  • Provide training and support to new and existing staff.
  • Ensure all work is performed in line with procedural and timeline requirements.
  • Requirements

  • Bachelor’s degree in Science or Engineering.
  • Minimum 5 years’ experience in a QA Validation role within the pharmaceutical or biopharma industry.
  • Strong knowledge of EU and FDA regulations on Qualification, Validation, and Computerised Systems.
  • Understanding of Data Integrity and Good Documentation Practice (GDP).
  • Excellent protocol and report writing skills.
  • Strong communication, organisational, and problem-solving ability.
  • Capable of managing workload and meeting deadlines independently.
  • Must be eligible to work in Ireland
  • Apply: Contact Darren Brown

    #LI-DB4


    Required Skill Profession

    Business Operations Specialists



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