Validation Compliance Specialist

QCS Staffing; Carlow; On-site; EUR 60,000 - 90,000; Full time

Job summary

QCS Staffing is seeking a Validation Compliance Specialist for a life sciences client in Ireland on an 11-month contract. The role centers on ensuring cGMP-aligned validation activities, maintaining the Validation Master Plan, and supporting regulatory audits and inspection readiness.

You will lead risk assessments, deviations/exception handling, change controls, CAPAs and investigations, with strong technical writing and collaboration with Quality, Engineering, Operations and global

Qualifications

• Experience in equipment and process validation in GMP pharma environments.
• Knowledge of validation lifecycle management and risk assessment methods.
• Ability to analyze complex technical data and investigations.
• Excellent communication, writing and cross-functional collaboration skills.

Responsibilities

• Provide compliance support for all validation activities per cGMP and site standards.
• Maintain Validation Master Plan and generate revalidation plans and governance reports.
• Support audits, inspection readiness, and ensure audit-ready documentation.
• Manage risk assessments, deviations, change controls, CAPAs and investigations.

Skills

Validation

cGMP compliance

Audit readiness

Root cause analysis

Project management

Technical writing

Regulatory awareness

Job description

Validation Compliance Specialist – Ireland – Initial 11-Month Contract – Life Sciences

Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting-edge drugs. As they continue to grow, they’re seeking an experienced Validation Compliance Specialist to support their dynamic team and drive forward groundbreaking projects in Ireland.

What You’ll Deliver

• Provide compliance support for all validation activities, ensuring alignment with cGMP, regulatory requirements, and site quality standards.
• Maintain the site Validation Master Plan and generate, review, and approve periodic revalidation plans, validation governance reports, and periodic review documentation.
• Support regulatory, divisional, and internal audits, coordinate inspection readiness activities, and ensure GMP-compliant validation documentation is available and audit ready.
• Manage compliance-related activities including risk assessments, deviation/exception management, change controls, CAPAs, investigations, and root cause analysis, ensuring timely closure of actions.

What you’ll need:

• Experience in equipment and process validation, equipment periodic revalidation, deviation/exception management, change control, and GMP-regulated pharmaceutical manufacturing environments.
• Strong knowledge of validation lifecycle management, validation master planning, risk assessment methodologies, and regulatory requirements across GMP operations.
• Ability to analyse and interpret complex technical and process data, support investigations, perform root cause analysis, and relate findings to equipment and process performance.
• Excellent communication, project management, and technical writing skills, with experience supporting audits, inspection readiness, and cross-functional collaboration with Quality, Engineering, Operations, and global stakeholders.