Specialist kontrole kakovosti II (m/ž/d)
Core
Specialist supporting routine analytical testing, reviewing and validating analytical results and documentation, and resolving deviations in a pharmaceutical manufacturing lab.
Role type
Specialist Quality Control II (Analytical)
Builds
Aseptic drug manufacturing and launch capabilities at the Aseptika Ljubljana site.
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
Microbiological analysis, Particulate analysis, Functional testing, GMP compliance, Data integrity, Analytical documentation review, Deviation management, Process improvement, Laboratory inspection readiness
Preferred skills
AI tools fluency, Experience in GMP environment
Technologies
Microsoft Office
Responsibilities
Review and validate analytical documentation and results; Resolve analytical deviations (OOx/OEX) and complaints; Ensure lab activities comply with GMP/cGxP; Provide technical support for microbiological, particulate, and functional testing; Prepare and review SOPs and analytical documentation; Guide analysts on complex technical issues; Establish and improve routine analytical processes; Prepare lab for inspections and defend the area during audits.
