Quality Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

This is an outstanding opportunity to join Thermo Fisher Scientific Inc. as a Quality Specialist I in our PDS Business unit. As a Quality Specialist, you will play a significant role in the detailed operation of our sterile injectable pharmaceutical production. Your contributions will be instrumental in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards!

Tasks

• Assure constant monitoring of sterile production lines (cleaning, mix-up, operations, defects) to ensure compliance with our company's quality standards.
• Implement thorough control measures to maintain outstanding quality throughout the production activities.

Quality

• Participate in defining and coordinating testing and validation activities for machinery, ensuring strict compliance with our company's quality standards.
• Collaborate with team members from different departments to settle quality standards and incorporate them into the production process.
• Actively participate in audits and efficiently implement corrective actions to continuously improve our processes.
• Analyze and resolve any problem or complaints to ensure that our products consistently meet the highest quality standards.
• Proactively propose GMP training courses based on supervising and control results to enhance the knowledge and skills of our team.

Procedure

• Collaborate with cross-functional teams in the development and revision of procedures and work instructions, closely ensuring their application in operational phases to maintain our high-quality standards.

Rapports:

Internal

• Develop a culture of collaboration and partnership by actively collaborating with QA/QC, Scientists, Warehouse, all department heads, and Engineering.

External

• Maintain positive relationships with machinery and equipment suppliers to ensure quality standards.
• Collaborate with external partners to implement effective processes and maintain outstanding quality standards.

Qualifications:

The preferred candidate has a strong experience in the pharmaceutical environment, shows a scientific background and knowledge of machinery, equipment, and methodologies for pharmaceutical production, GMP regulations included.

Familiarity with aseptic production challenges is a major plus.

Confirmed experience in QA/Production in pharmaceutical companies is important, demonstrating the ability to efficiently implement quality control measures.

Languages:

Italian and English

Personality Traits:

• Highly organized: Your exceptional communication skills will enable you to handle multiple tasks and ensure the smooth flow of our production operations.
• Strong observation skills: Your keen eye for detail will allow you to promptly identify any deviations or issues and address them efficiently.
• Excellent communication skills: Your ability to build positive relationships and effectively connect with colleagues at all levels will contribute to a collaborative work environment in a purposeful manner

Thermo Fisher is able to offer interesting benefits, an important career path, learning opportunities.

Join our outstanding team and play a relevant role in ensuring the detailed production of pharmaceuticals!