At a Glance
- Tasks: Ensure compliance and quality in pharmaceutical manufacturing as a Qualified Person.
- Company: Leading pharmaceutical company committed to excellence and innovation.
- Benefits: Attractive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team focused on continuous improvement and compliance.
- Why this job: Play a crucial role in ensuring safe and effective medicinal products reach patients.
- Qualifications: Must be eligible as a Qualified Person with GMP experience.
The predicted salary is between 55000 - 70000 £ per year.
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.
Qualified Person in Brighton employer: Nexia
Nexia in Brighton is an exceptional employer, offering a dynamic work culture that prioritises employee growth and development within the pharmaceutical sector. With a commitment to compliance and quality, employees benefit from mentorship opportunities and a collaborative environment, making it an ideal place for those seeking meaningful and rewarding careers in GMP regulations.
We think you need these skills to ace Qualified Person in Brighton
Qualified Person Certification
EU/UK GMP Compliance
Batch Release
Reviewing Batch Documentation
Deviations Management
Investigations Management
CAPA Management
