QA Engineer

• Ensure quality management of combination product assembly processes, packaging operations, and compliance with GMP and regulatory requirements
• Develop and maintain quality systems in accordance with pharmaceutical regulations, GMP requirements, and Sandoz internal guidelines
• Provide quality support for combination product assembly and finished product packaging operations
• Review and approve manufacturing documentation, validation documentation, and batch manufacturing records
• Manage deviations, complaints, changes, risk assessments, and CAPA implementation
• Support equipment qualification, process validation, and introduction of new products and technologies
• Perform batch documentation reviews
• Participate in internal and external audits and regulatory inspections
• Collaborate with Manufacturing, Engineering, Validation, Quality Control, Regulatory Affairs, and other technical functions
• Support transfer of new products into commercial manufacturing

QA expert ensuring GMP compliance for Sandoz biosimilar manufacturing in Slovenia

QA Operations Expert – upravljanje kakovosti

QA Operations Expert ensuring GMP compliance for Sandoz combination-product assembly and packaging. Supporting validations, audits, CAPA, and new biosimilar manufacturing in Slovenia.

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QA Operations Expert – upravljanje kakovosti