QA Shift Lead: Quality Oversight & Compliance

Norgine

Hengoed

Presencial

GBP 35 000 - 48 000

Tempo integral

Há 5 dias
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Resumo da oferta

Norgine, a leading pharmaceutical company, is seeking a Quality Assurance Officer to provide independent QA oversight of manufacturing operations during shift activities. You will ensure GMP compliance, review batch documentation, and support deviations, CAPAs, and change controls to safeguard patient safety.

This 12-month fixed-term contract with shift work offers the chance to contribute to an inspection-ready site, coach operations on quality standards, participate in audits, and maintain

Qualificações

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

Responsabilidades

  • 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 batch disposition, 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.

Conhecimentos

GMP knowledge
Quality systems
Data integrity
GxP understanding

Formação académica

Bachelor's degree in science

Ferramentas

CAPA processes
Change control
Documentation review

Descrição da oferta de emprego

Norgine, a leading pharmaceutical company, is seeking a Quality Assurance Officer to provide independent QA oversight of manufacturing operations during shift activities. You will ensure GMP compliance, review batch documentation, and support deviations, CAPAs, and change controls to safeguard patient safety.

This 12-month fixed-term contract with shift work offers the chance to contribute to an inspection-ready site, coach operations on quality standards, participate in audits, and maintain

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