Validation Compliance Specialist

Quanta Consultancy Services Ltd; Carlow; On-site; EUR 65,000 - 90,000; Full time

Job summary

Quanta Consultancy Services Ltd is seeking a Validation Compliance Specialist to join a global Life Sciences client in Ireland. The role focuses on supporting validation activities, ensuring cGMP alignment and audit readiness across manufacturing operations.

You will maintain the Validation Master Plan, oversee revalidations, and collaborate with Quality, Engineering, Operations, and global stakeholders. Strong analytical, regulatory knowledge, and technical writing skills are essential.

Qualifications

• Experience in equipment and process validation within GMP-regulated pharmaceutical manufacturing environments.
• Strong knowledge of validation lifecycle management, validation master planning, risk assessment methodologies, and regulatory requirements.
• Ability to analyse and interpret complex technical and process data, support investigations and root cause analysis.
• Excellent communication, project management and technical writing skills, with audit support and cross-functional collaboration experience.

Responsibilities

• Provide compliance support for all validation activities to ensure alignment with cGMP and regulatory requirements.
• Maintain the site Validation Master Plan and generate/approve revalidation plans and governance reports.
• Support audits, coordinate inspection readiness activities and ensure audit-ready validation documentation.
• Manage compliance activities including risk assessments, deviation management, change controls, CAPAs and investigations.

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.