Odgovorna oseba za sproščanje zdravil na trg / QP (m/ž/d)
Core
Responsible Person for Marketing Authorization Holder (QP) ensuring batch release and certification of aseptic pharmaceutical products in compliance with EU GMP and local regulations.
Role type
Senior Quality Assurance / Regulatory Compliance Specialist (QP)
Builds
Certified batches of aseptic injectable/sterile medicines for global patient use
Domain
Pharmaceutical manufacturing (aseptic/sterile production)
Required skills
EU GMP knowledge, batch release certification, deviation investigation, change control assessment, regulatory inspection readiness, quality decision making
Preferred skills
aseptic production experience, quality control/assurance background, validation experience, regulatory audit preparation
Technologies
GMP systems, QMS tools, stability testing programs
Responsibilities
Certify and release batches in accordance with EU GMP and local laws; oversee aseptic production processes; review and approve production reports; participate in deviation, OOS, recall, and complaint investigations; assess impact of changes and validation activities; support regulatory inspections; foster quality culture and GMP training
Seniority
Senior, hands-on IC
