Qualified Person

Key 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.

Essential 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.

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