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Qualified Person (QP) – Manufacturing & Compliance Role
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.
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Essential Requirements
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- 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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Skills
Qualified Person
GMP
Batch Release
Documentation Review
Deviations Management
Investigations
CAPA
Change Control
Quality Assurance
Regulatory Inspections
Stakeholder Management
Communication
Mentoring
Continuous Improvement
Risk Management
Technical Reports