Sachkundige Person / Qualified Person für Klinische Prüfpräparate (Bulk Drug Product) (all genders) (Vollzeit, unbefristet)
Core
Responsible for the manufacturing, testing, release, storage, and shipping of clinical trial bulk drug products, ensuring compliance with GMP and regulatory requirements.
Role type
Qualified Person (QP) for Clinical Trial Bulk Drug Products
Builds
Clinical trial drug products (Bulk Drug Products)
Domain
Pharmaceutical / Clinical Trials / Regulatory Compliance
Required skills
GMP compliance, batch release (GMP-Confirmation), quality assessment of active pharmaceutical ingredients (APIs), root cause analysis, CAPA management, regulatory document review, SOP development, audit participation, process improvement
Preferred skills
ATMP quality assessment, Lean Six Sigma, project management
Technologies
GMP guidelines, CTR No 536/2014, AMG § 14, AMG § 15
Responsibilities
Exercise QP functions per AMG § 14 and GMP guidelines; Ensure proper manufacturing, testing, release, storage, and shipping of trial products; Investigate and evaluate quality events; Assess changes to manufacturing processes and quality documents; Participate in audits and regulatory inspections; Develop and revise SOPs and Quality Agreements; Drive continuous process optimization.
Seniority
Senior, hands-on IC