Qualified Person

Nexia; Brighton; On-site; GBP 95,000 - 120,000; Full time

Job summary

Nexia seeks an experienced Qualified Person to certify and release batches under UK/EU GMP, ensuring products are manufactured and tested to high compliance standards. The role includes QA oversight across manufacturing, packaging and testing and acting as a QP during regulatory inspections.

The successful candidate will review deviations and CAPAs, mentor QA staff, and drive continuous improvement to strengthen compliance and efficiency within the site operations.

Qualifications

• Qualified Person eligibility under UK legislation.
• Experience reviewing batch documentation and making disposition decisions.
• Strong knowledge of UK and EU GMP regulations.

Responsibilities

• Perform QP certification and batch release according to EU/UK GMP.
• Provide QA oversight for manufacturing, packaging and testing activities.
• Support regulatory inspections and customer audits as QP representative.

Skills

QP Certification

GMP Knowledge

QA Oversight

Regulatory Inspections

Stakeholder Management

Documentation Review

Quality Systems

Process Improvement

Mentoring

UK/EU GMP

Batch Disposition

Sterile/Biological/Pharma

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.