Quality Assurance di Operations Industriali- categorie protette l. 68/99
Core
Ensuring quality of hemoderivatives products through batch record review, regulatory compliance, and GMP adherence in a pharmaceutical production environment.
Role type
Quality Assurance Specialist (Industrial Processes)
Builds
Production batches and compliant documentation for hemoderivatives
Domain
Pharmaceutical industry / Industrial production
Required skills
Batch record review, GMP compliance, CAPA implementation, Production process knowledge, Regulatory standards knowledge, Documentation management, Plasma reception verification
Preferred skills
Scientific degree (Chemical/Biological/Environmental/Biotech), English language proficiency, Team collaboration
Technologies
Excel
Responsibilities
Review and ensure execution of batch record review in compliance with SOPs and regulations, Open and manage events identified during batch record review or reported by production operators, Review production procedures and Master Batch Record, Identify improvement opportunities and implement CAPA to increase GMP compliance, Collaborate with Production to identify and resolve compliance gaps, Prepare samples for equipment cleaning, Verify compliance with plasma reception requirements
