Monitoring and ensuring the implementation of Quality Assurance elements, regulatory requirements, and applicable standards in pharmaceutical manufacturing
Job Summary
Monitoring and ensuring the implementation of Quality Assurance elements, regulatory requirements, and applicable standards in pharmaceutical manufacturing.
Coordinating and executing Quality Assurance activities related to product release procedure, reviewing batch documentation and ensuring compliance with cGMP requirements.
Involvement in quality processes related to investigations, complaints, market actions, change controls, CAPA and MDCP CAPA systems, regulatory inspections and internal audits, risk management, projects, and technology transfer.
Matching Summary
Monitoring and ensuring the implementation of Quality Assurance elements, regulatory requirements, and applicable standards in pharmaceutical manufacturing.
Skills & Requirements
Must-have
Quality Assurance elements
regulatory requirements
cGMP requirements
product specifications
pharmaceutical manufacturing
Nice-to-have
interpersonal and communication skills
teamwork and collaboration
accountable, adaptable, systematic, punctual
attention to detail
analytical thinking
problem-solving abilities
work independently
manage multiple priorities
Key Requirements
University degree or 300 ECTS
Proficiency in Croatian and English language
Competency in MS Office applications and the Internet
At least 1 year of working experience
Experience in Method 1, Veeva, SAP, EDMS, LIMS is an advantage
Experience in Quality Assurance or pharmaceutical manufacturing is an advantage
Strong knowledge of GMP and relevant regulatory requirements