Quality Assurance Specialist
1 mese fa
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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