Višja Odgovorna oseba za sproščanje zdravil na trg (m/ž/d)
Core
Senior Responsible Person for Batch Release ensuring compliance with EU GMP and legal requirements for aseptic pharmaceutical manufacturing.
Role type
Senior Quality Assurance Specialist (Regulatory Release)
Builds
Certified and released batches of aseptic medicinal products for global patients
Domain
Pharmaceutical manufacturing (Aseptic)
Required skills
EU GMP compliance, Batch release certification, Aseptic production expertise, Quality decision making, Regulatory inspection readiness, Change impact assessment, Deviation handling, Validation oversight, Knowledge transfer, Cross-functional collaboration
Preferred skills
Regulatory inspection experience, Team leadership and mentoring
Technologies
EU GMP, Priloga 16, ZZdr-2
Responsibilities
Certify and release product batches per EU GMP and legal standards; Make quality decisions and oversee aseptic process compliance; Review and approve final documentation and batch release assessments; Guide complex deviations, OOS results, recalls, and quality escalations; Assess impact of changes, validations, and stability programs on product release; Lead regulatory inspections and site readiness; Strengthen quality culture and GMP excellence through knowledge transfer.
Seniority
Senior, hands-on IC