Specialist upravljanja kakovosti II - operacije (m/ž/d)
Core
Specialist supporting aseptic drug production operations by reviewing reports, approving documentation, and ensuring timely batch release.
Role type
Quality Operations Specialist (Pharmaceutical Manufacturing)
Builds
Aseptic drug production batches and release documentation for global patients
Domain
Pharmaceutical manufacturing / Aseptic drug production
Required skills
Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Compliance, Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Data Integrity, Managing Ambiguity, Operational Excellence, Problem Solving
Preferred skills
Quality Management Systems (QMS), Internal Quality Auditing, Quality Control (QC), Digital Fluency, Collaboration
Technologies
Microsoft Office
Responsibilities
Review production reports, batch records, and analytical documentation; Approve analytical data and test results; Coordinate batch release in compliance with regulations; Investigate deviations and manage corrective/preventive actions; Oversee process validation and change control; Prioritize tasks in a dynamic environment
Seniority
Mid-level, hands-on IC
