Qualified Person / Sachkundige Person (m/w/d)

Thermo Fisher Scientific UK

Weil am Rhein, Germany
Not specified; not specified; attractive compensat...
Release of clinical trial preparations
Conducting international audits
Regulatory compliance with amg and eu annex
The role focuses on the release and certification of clinical trial preparations for the Weil am Rhein site while managing customer projects independently

Job Summary

  • The role focuses on the release and certification of clinical trial preparations for the Weil am Rhein site while managing customer projects independently.
  • Candidates will be responsible for direct contact with authorities, creating QP declarations, and approving standard operating procedures.
  • Thermo Fisher Scientific offers excellent development and career prospects within a global company committed to integrity and innovation.

Matching Summary

The role focuses on the release and certification of clinical trial preparations for the Weil am Rhein site while managing customer projects independently.

Salary

Not specified; Not specified; Attractive compensation and occupational pension plan

Skills & Requirements

Must-have

  • Release of clinical trial preparations
  • Conducting international audits
  • Regulatory compliance with AMG and EU Annex
  • Direct contact with authorities
  • Review of manufacturing documents

Nice-to-have

  • Customer project management experience
  • Analytical thinking in risk assessment
  • High service orientation towards clients
  • Experience with deviation root cause analysis

Key Requirements

  • Degree in Pharmacy
  • 2 years experience in pharmaceutical quality control
  • License as Pharmacist (Approbation)
  • Qualified Person status per §15 AMG
  • German and English language fluency

Work Rights

Not specified

Tailored Resume

Cover Letter