Qualified Person / Sachkundige Person (m/w/d)
Core
Release and certification of clinical trial preparations for the Weil am Rhein site, including audit execution and quality assurance training.
Role type
Qualified Person (QP) / Sachkundige Person
Builds
Clinical trial drug supplies and related quality documentation for global clinical studies
Domain
Pharmaceutical clinical supply chain and quality assurance
Required skills
Pharmaceutical quality control, regulatory compliance (AMG/EU Annex 13/16), audit execution, deviation analysis, SOP approval, complaint handling, laboratory outsourcing management, risk assessment
Preferred skills
Pharmaceutical manufacturing experience, customer service orientation
Technologies
None stated
Responsibilities
Release decisions for clinical trial preparations, customer project support, audit execution, direct contact with authorities, creation of QP declarations, SOP approval, complaint processing, approval of contract lab assignments, customer QA consultation, batch usage decisions, deviation statement review, root cause analysis, manufacturing and validation document review
Seniority
Mid-level, hands-on IC
