QA Validation Specialist New

2 weeks ago

Tipperary, Ireland CPL Full time

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 — [email protected]

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