Quality Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Quality Specialist - Quality Manufacturing (Monza)

This is an outstanding opportunity to join Thermo Fisher Scientific Inc. as a Quality Specialist in our PDS Business unit. As a Quality Specialist, you will play a meaningful 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!

Responsibilities

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

Relations:

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

• Strong experience in the pharmaceutical environment, with a scientific background and knowledge of machinery, equipment, and methodologies for pharmaceutical production, including GMP regulations.
• Familiarity with aseptic production challenges is a major plus.
• Confirmed experience in QA/Production in pharmaceutical companies, demonstrating the ability to efficiently implement quality control measures.
• Proficiency in Italian and English.

Personality Traits

• Highly organized: Your outstanding communication skills will enable you to balance multiple tasks and ensure the smooth flow of our production operations.
• Demonstrating strong observation skills: Your ability to notice detail will enable you to quickly identify any deviations or issues and address them efficiently.
• Strong communication skills required to foster positive relationships and connect effectively with colleagues.

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