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Quality System Manager

2 mesi fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Quality System Manager

Thermo Fisher Scientific Inc. is seeking a Quality System Manager to join our team in Monza, Italy.

Main Responsibilities:

  • Coordinate and support the Quality System through process design and control strategies.
  • Build a robust quality regime and a framework that supports an effective approach to Change Control, Documentation and Training, Product Quality Review, Continuous Process Verification, Vendor Management, and Quality Agreement.
  • Sponsor and drive continuous improvement programs related to the above topics.
  • Lead the competence area during customer and regulatory agency inspections.

Requirements:

  • Bachelor's Degree in Pharmacy or Pharmaceutical Chemistry.
  • Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
  • Experience with 21CFR Part 11 and Annex 11.
  • Previous supervision or management experience.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • At least 7 years of experience in a regulated industry, or 5 years with related technical knowledge.
  • Project Management, Supervision, or Management experience.
  • Fluency in English.

Competencies:

  • Strong communication skills.
  • Ability to make quality decisions by calculating risks and understanding their impacts.
  • Collaboration and proactivity.
  • Leadership focused on achieving outcomes.
  • Project management skills, with the ability to work on multiple projects simultaneously.
  • Managing relationships with individuals involved in the project.

About Us:

Thermo Fisher Scientific Inc. is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace, where everyone feels valued and respected. We encourage applications from individuals of all backgrounds and abilities.

We are committed to providing reasonable accommodations to individuals with disabilities. If you require a reasonable accommodation to apply for a position, please contact us at [email address]. We will work with you to meet your accessibility needs.