Sachkundige Person / Qualified Person (m/w/d) Pharma
Core
Responsible for the release of manufactured pharmaceutical products in compliance with legal requirements (Annex 16) and GMP regulations.
Role type
Qualified Person (QP) for pharmaceutical manufacturing
Builds
Pharmaceutical products
Domain
Pharmaceutical industry / Regulatory compliance
Required skills
Pharmaceutical law expertise, GMP regulations knowledge, independent decision-making, process improvement, analytical thinking, negotiation skills
Preferred skills
Strategic thinking, problem-solving, flexibility
Technologies
GMP documentation systems, regulatory databases
Responsibilities
Approve manufactured products, review and approve GMP-relevant documents (SOPs, CAPAs, deviations), act as contact for GMP/regulatory compliance questions, collaborate with production and quality control, represent the company in inspections and audits
Seniority
Mid-level, hands-on IC
