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Qualification Expert

2 mesi fa

Ivrea, Piemonte, Italia Novartis Farmacéutica A tempo pieno
About the Role

Main Responsibilities:

Operational
  • Lead the qualification of laboratories, analytical instruments, and systems to ensure compliance with cGxP standards.
  • Develop and implement qualification plans to meet business needs, ensuring readiness and release of instruments.
  • Monitor and maintain the qualification/calibration status of analytical equipment and associated utilities and facilities.
  • Manage change control processes for laboratory implementation, including CAPA and task loop.
  • Author and review SOPs within the area of responsibility.
  • Ensure laboratories are maintained according to cGxP standards and comply with applicable regulatory requirements.
  • Prepare for and contribute to GxP audits/inspections, ensuring methods and procedures are up-to-date.
  • Manage documentation and methods according to cGxP standards.
Leadership & Culture
  • Identify and review training needs for in-scope associates and ensure they are qualified for GMP tasks.
  • Monitor training compliance for in-scope associates and maintain a list of subject matter experts.
  • Create a work environment that fosters high employee engagement and promotes a culture of curiosity, inspiration, and unbossed leadership.
  • Role model the company culture and ensure leaders and associates are aware of and aligned with expectations.

About Novartis

Novartis is a global healthcare company that is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.