Odgovorna oseba za sproščanje zdravil na trg / QP (m/ž/d)
Core
Responsible for releasing pharmaceutical products to the market, ensuring compliance with GMP and regulatory standards for cell and gene therapy manufacturing.
Role type
Quality Assurance / Quality Control Specialist (QP)
Builds
Pharmaceutical products (cell and gene therapies)
Domain
Pharmaceuticals / Biotechnology
Required skills
GMP compliance, regulatory knowledge, risk assessment, decision making, quality management systems, change management, corrective and preventive actions, documentation review
Preferred skills
Certificate for batch release, AI fluency, digital tools proficiency
Technologies
Microsoft Office
Responsibilities
Release pharmaceutical products to the market, review and critically assess production and analytical documentation, make final release decisions, ensure compliance with regulatory requirements, investigate deviations and handle complaints, approve and improve GMP documentation, support new product/process introductions
Seniority
Mid-level, hands-on IC
