QP (Qualified Person)
Thermo Fisher Scientific seeks a Qualified Person to ensure pharmaceutical manufacturing quality and regulatory compliance at their UK facility. The role involves batch certification, GMP oversight, investigations, and continuous improvement within sterile manufacturing operations.
Responsibilities
- Execute Qualified Person batch certification and disposition per EU and US regulatory frameworks
- Conduct audits, self-inspections, and spot checks to verify GMP compliance
- Lead investigations, root cause analysis, and approve critical deviations and product complaints
- Drive quality system improvements and maintain inspection-ready operational state
- Establish client communication and alignment on quality expectations and regulatory requirements
Requirements
- Degree in Chemistry, Pharmacy, or Microbiology
- Minimum 3 years as Qualified Person under EU pharmaceutical directives 2001/83/EC and 2001/82/EC
- Substantial experience in sterile pharmaceutical manufacturing quality functions
- Current knowledge of GMP guidelines: UK Orange Guide, EU Eudralex Volume 4, US CFRs
- Strong scientific and technical knowledge of pharmaceutical processes
- Not on FDA DEBARMENT LIST
- Leadership experience and cross-functional team management capability
Vacancy posted 28 days ago
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