Quality Assurance Specialist

3 settimane fa


Forlì, Emilia-Romagna, Italia Novartis Farmacéutica A tempo pieno

Quality Assurance Specialist Role

The Quality Assurance Specialist is responsible for supporting the maintenance of the quality management system at a local level, ensuring compliance with GMP regulations and corporate guidelines. This role involves implementing, monitoring, and adhering to external and internal requirements.

Main Responsibilities:

  • Ensure compliance with GMPs and Health Authorities' requirements at a local level
  • Contribute to maintaining the local quality system as per GMPs and corporate guidelines
  • Review and redact SOPs, records, protocols, and reports according to GMPs, National/Corporate Guidelines, and health authorities' requirements
  • Manage GMP logbooks, documentation, and training records
  • Support the Quality Site Head with critical issues and participate in self-inspections and external audits
  • Manage Out of Specifications, System Suitability Test failures, Out of Trend, Deviations, CAPA, Change Controls, Complaints, and suppliers' qualification

Requirements:

  • Fluent English verbally and in writing
  • 1+ years of experience in a Quality department
  • Strong affinity with quality issues, good organizational skills, and knowledge of quality systems
  • Bachelor's degree in Pharmaceuticals, Chemical, or Biological sciences

About Novartis:

Novartis is a community of smart, passionate people working together to help people with diseases and their families. We combine innovative science with a sense of urgency to achieve breakthroughs that change patients' lives.



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