Qualification Expert Lead

5 giorni fa


Ivrea, Piemonte, Italia Novartis A tempo pieno
Job Description

The role of Qualification Expert Lead is a critical position within our organization, responsible for ensuring compliance to cGxP standards for topics within the area of responsibility. This includes safety testing, monitoring, and trending, as well as providing guidance, support, and leadership for the implementation of analytical standards.

Main Responsibilities:

  • Lead initial qualification of laboratories, associated analytical instruments, and systems
  • Plan qualification activities according to business needs and ensure readiness and release of instruments
  • Ensure qualification/calibration status of analytical equipment and associated utilities and facilities
  • Manage change control processes associated with laboratory implementation
  • Author and review SOPs within the area of responsibility
  • Ensure laboratories are maintained according to cGxP standards and comply with applicable regulatory requirements
  • Contribute to GxP audits/inspections and ensure methods and procedures are up-to-date

The ideal candidate will have strong leadership skills and be able to motivate teams to achieve high levels of performance. A salary range of $80,000 - $120,000 per year is estimated based on industry standards and location.


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