Qualified Person

Nexia; Brighton; On-site; GBP 90,000 - 120,000; Full time

Job summary

Nexia in the United Kingdom is seeking a Qualified Person with extensive GMP experience to certify batches and release products in line with UK/EU regulations. You will oversee QA for manufacturing, packaging and testing activities, support regulatory inspections, and mentor teams on GMP standards.

The role requires proven expertise in batch dispositions, deviations, CAPAs and change controls, with strong communication and stakeholder management to drive continuous improvement across quality

Qualifications

• Must hold Qualified Person status with UK/EU approvals.
• Experience certifying sterile, biological, vaccine or pharmaceutical products.
• Strong knowledge of UK and EU GMP regulations.
• Experience reviewing batch documentation and making disposition decisions.
• Proven track record managing deviations, investigations and CAPAs.

Responsibilities

• Perform Qualified Person (QP) certification and batch release in accordance with EU/UK GMP.
• Ensure all medicinal products have been manufactured and tested in compliance with Marketing Authorisations and GMP requirements.
• Review batch documentation, deviations, investigations, CAPAs and change controls to support batch disposition decisions.
• Provide QA oversight for manufacturing, packaging and testing activities.
• Support regulatory inspections and customer audits, acting as a QP representative where appropriate.
• Provide expert GMP guidance to manufacturing, quality control, validation and supply chain teams.
• Review and approve quality documentation including SOPs, validation protocols, risk assessments and technical reports.
• Support management of quality systems including deviations, CAPA, complaints, change control and risk management.
• Participate in product quality reviews and ongoing process verification activities.
• Contribute to continuous improvement initiatives to strengthen compliance and operational efficiency.
• Mentor and support quality personnel on GMP expectations and regulatory requirements.
• Eligible to act as a Qualified Person under UK legislation (permanent QP status).
• Significant experience working within a GMP pharmaceutical or biotechnology manufacturing environment.
• Strong knowledge of UK and EU GMP regulations.
• Experience certifying sterile, biological, vaccine or pharmaceutical products.
• Proven experience reviewing batch documentation and making batch disposition decisions.
• Experience managing deviations, investigations and CAPAs.
• Excellent communication and stakeholder management skills.

Skills

Qualified Person

GMP expertise

Quality Assurance

Regulatory compliance

Batch release

Stakeholder management

Job description

• Perform Qualified Person (QP) certification and batch release in accordance with EU/UK GMP.
• Ensure all medicinal products have been manufactured and tested in compliance with Marketing Authorisations and GMP requirements.
• Review batch documentation, deviations, investigations, CAPAs and change controls to support batch disposition decisions.
• Provide QA oversight for manufacturing, packaging and testing activities.
• Support regulatory inspections and customer audits, acting as a QP representative where appropriate.
• Provide expert GMP guidance to manufacturing, quality control, validation and supply chain teams.
• Review and approve quality documentation including SOPs, validation protocols, risk assessments and technical reports.
• Support management of quality systems including deviations, CAPA, complaints, change control and risk management.
• Participate in product quality reviews and ongoing process verification activities.
• Contribute to continuous improvement initiatives to strengthen compliance and operational efficiency.
• Mentor and support quality personnel on GMP expectations and regulatory requirements.
• Eligible to act as a Qualified Person under UK legislation (permanent QP status).
• Significant experience working within a GMP pharmaceutical or biotechnology manufacturing environment.
• Strong knowledge of UK and EU GMP regulations.
• Experience certifying sterile, biological, vaccine or pharmaceutical products.
• Proven experience reviewing batch documentation and making batch disposition decisions.
• Experience managing deviations, investigations and CAPAs.
• Excellent communication and stakeholder management skills.