GMP Validation & Compliance Specialist

PSC Biotech® Corporation; Carlow; On-site; EUR 60,000 - 95,000; Full time

Job summary

PSC Biotech seeks a Compliance Specialist (Validation) to join our team in a cGMP regulatory environment. The role focuses on providing compliance support across validation activities, audits, risk assessments, and documentation to ensure ongoing GMP conformance.

The successful candidate will maintain the Validation Master Plan, manage periodic reviews, and help prepare for inspections. Strong analytical, communication, and cross-functional collaboration skills are required.

Qualifications

• Experience in GMP manufacturing settings with compliance focus.
• Knowledge of cGMP regulatory requirements and QA systems.
• Ability to generate and review validation documentation.

Responsibilities

• Provide compliance support for validation activities.
• Support Regulatory, Divisional and Internal audits.
• Respond to operational areas ensuring cGMP compliance.
• Maintain Validation Master Plan and periodic validation reports.
• Coordinate annual product review validation chapters and governance reports.
• Assist with inspection readiness and GMP-compliant documentation.

Skills

GMP manufacturing

Deviation management

Change control

Equipment validation

Project management

DeltaV / automation

Education

Applied Pharmaceutical/Chemical sciences

Engineering qualification

Tools

DeltaV

Pi System

Job description

PSC Biotech seeks a Compliance Specialist (Validation) to join our team in a cGMP regulatory environment. The role focuses on providing compliance support across validation activities, audits, risk assessments, and documentation to ensure ongoing GMP conformance.

The successful candidate will maintain the Validation Master Plan, manage periodic reviews, and help prepare for inspections. Strong analytical, communication, and cross-functional collaboration skills are required.