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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
QP Certification
Batch Release
EU GMP
UK GMP
Quality Assurance
CAPA Management
Deviation Investigation
Change Control
Regulatory Inspections
Sterile Product Certification
Risk Management
Stakeholder Management
Validation Protocols
Product Quality Review
Compliance Oversight
Technical Reporting