Quality Assurance Shift Lead - GMP & Compliance

Norgine B.V.; Cefn Hengoed; On-site; GBP 42,000 - 56,000; Full time

Job summary

Norgine B.V. is seeking a Quality Assurance Officer to provide independent QA oversight during shift activities, ensuring GMP compliance and adherence to Norgine standards. The role safeguards product quality and patient safety while enabling efficient site operations.

You will review batch documentation, support deviations and CAPAs, and promote data integrity. Join a team focused on excellence in pharmaceutical quality and regulatory readiness.

Qualifications

• Experience within a GMP-regulated pharmaceutical, medical device, or similarly controlled environment.
• Working knowledge of GMP and Good Documentation Practice requirements.
• Understanding of pharmaceutical quality systems, including deviations, CAPA, change control, risk assessment, and document control.
• Experience analysing quality issues and supporting compliance-driven decision-making.

Responsibilities

• Provide QA oversight across manufacturing, packaging, warehouse, engineering, and related operational 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 batch disposition activities.
• Manage and support 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

Quality assurance methodologies

Risk management

Attention to detail

Written communication

Data management

Policies & Health & Safety

Education

Bachelor's degree in a scientific discipline

Job description

Norgine B.V. is seeking a Quality Assurance Officer to provide independent QA oversight during shift activities, ensuring GMP compliance and adherence to Norgine standards. The role safeguards product quality and patient safety while enabling efficient site operations.

You will review batch documentation, support deviations and CAPAs, and promote data integrity. Join a team focused on excellence in pharmaceutical quality and regulatory readiness.