Quality Assurance Manager
4 settimane fa
Thermo Fisher Scientific Inc. is seeking a Quality System Manager to join our team in Italy. As the Quality System Manager, you will coordinate and support the Quality System through process design and control strategies. Your main responsibilities will include:
Main Responsibilities:
- Building 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.
- 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).
- 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.
- Leadership skills.
- Problem-solving abilities.
- Strong decision-making skills.
- Excellent communication, negotiation, and influence skills.
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.
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