Quality Assurance Specialist

1 mese fa


Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Description:

Quality System Manager

Thermo Fisher Scientific Inc. is seeking a Quality System Manager to join its team in Monza, Italy. As a key member of the organization, you will be responsible for coordinating and supporting the Quality System through process design and control strategies.

Main Responsibilities:

  • Building a robust quality regime and framework that supports an effective approach to Change Control, Documentation, and Training.
  • Sponsoring and driving continuous improvement programs related to the above topics.
  • Leading 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).

Professional Experience:

  • At least 7 years of experience in a regulated industry.
  • 5 years with related technical knowledge.

Foreign Languages:

  • Fluency in English.

Personality Traits:

  • Leadership skills.
  • Problem-solving abilities.
  • Strong decision-making skills.
  • Excellent communication, negotiation, and influence skills.

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 Thermo Fisher Scientific Inc.

  • We are an equal opportunity employer.
  • We are committed to creating a diverse and inclusive workplace, where everyone feels valued and respected.

Reasonable Accommodation:

  • 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].


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