Validation Specialist - Pharma Quality & Compliance

Norgine Pharma SA; Hengoed; On-site; GBP 45,000 - 75,000; Full time

Job summary

Norgine is seeking a Validation Specialist to join the Validation and Quality team. You will provide technical expertise and operational support across validation activities to maintain regulatory compliance, inspection readiness and continuous improvement.

You will plan, coordinate and deliver qualification, validation, revalidation and periodic review across equipment, facilities, utilities, processes, cleaning validation and computerised systems.

Qualifications

• Experience in qualification, validation, revalidation and periodic review.
• Knowledge of cGMP principles and EU/FDA regulatory expectations.
• Experience preparing validation plans, protocols, reports and procedures.
• Experience conducting risk assessments and supporting regulatory inspections or audits.
• Strong written and verbal communication skills.

Responsibilities

• Plan and deliver qualification, validation, revalidation and periodic review activities in line with site strategies and regulatory requirements.
• Prepare, review and maintain validation plans, protocols, reports, schedules and procedures.
• Maintain compliant validation activities and records throughout the validation lifecycle.
• Support cross-functional projects, risk assessments, change controls and validation impact assessments.
• Provide validation guidance and support compliance with applicable GMP, MHRA, EU and FDA requirements.
• Act as a Validation Subject Matter Expert when required.
• Support investigations, CAPAs, audits and other quality events.
• Monitor trends and risks, produce validation metrics, deliver training and contribute to continuous improvement.
• Collaborate with site and global stakeholders to achieve validation objectives.

Skills

Validation expertise

Regulatory knowledge

Data analysis

Documentation skills

Communication

Education

Scientific degree or engineering

Job description

Norgine is seeking a Validation Specialist to join the Validation and Quality team. You will provide technical expertise and operational support across validation activities to maintain regulatory compliance, inspection readiness and continuous improvement.

You will plan, coordinate and deliver qualification, validation, revalidation and periodic review across equipment, facilities, utilities, processes, cleaning validation and computerised systems.