Quality Assurance Shift Lead — GMP Oversight & Patient Safety

Norgine; Hengoed; On-site; GBP 32,000 - 46,000; Full time

Job summary

Norgine is seeking a Quality Assurance Officer to provide independent QA oversight of manufacturing operations during shift activities, ensuring GMP compliance and alignment with Norgine standards. You will review batch documentation and support batch disposition while advising on quality issues.

This 12-month fixed-term contract with shift work requires experience in GMP environments, deviations, CAPA, change controls, risk assessment and data integrity.

Qualifications

• Experience in a GMP-regulated pharmaceutical, medical device, or similar environment.
• Knowledge of GMP and Good Documentation Practice requirements.
• Experience analysing quality issues and supporting compliance decisions.
• Experience with deviations, CAPA, change control and risk assessment.

Responsibilities

• Provide QA oversight across manufacturing, packaging, warehouse, engineering, and related activities.
• Conduct shop-floor GMP inspections and support compliance monitoring.
• Assess quality issues and make timely, risk-based quality decisions.
• Review batch documentation and quality records to support disposition.
• Manage deviations, CAPAs, change controls, and quality events.
• Promote GMP, Good Documentation Practice, and Data Integrity compliance.
• Coach and support operational teams on quality standards and best practices.
• Participate in audits and regulatory inspections, ensuring continued inspection readiness.
• Maintain effective communication and quality handovers between shifts.

Skills

GMP knowledge

Quality systems

Risk assessment

Documentation review

Data integrity

Education

Bachelor's degree in a scientific discipline

Job description

Norgine is seeking a Quality Assurance Officer to provide independent QA oversight of manufacturing operations during shift activities, ensuring GMP compliance and alignment with Norgine standards. You will review batch documentation and support batch disposition while advising on quality issues.

This 12-month fixed-term contract with shift work requires experience in GMP environments, deviations, CAPA, change controls, risk assessment and data integrity.