Pharma Validation & Compliance Specialist (11-Month)

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

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.