**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Discover Impactful Work**:
As a Quality System and Improvement Specialist at Thermo Fisher Scientific Inc., you will have the opportunity to join a new mRNA GMP facility in Monza and contribute to the general compliance of the mRNA site.
In this role, you will provide advice on strategies applicable to the innovative mRNA product and collaborate with different teams such as Production, Quality, Project management, and Control.
Your expertise will be crucial in ensuring the compliance of the company to quality regulations, including laws, GMP, FDA, and ATMP, through the management of quality system.
**Responsibilities**:
- Conduct thorough assessments and audits to verify the suitability, reliability, and performance of quality system used in GMP manufacturing and testing.
- Collaborate with Quality Assurance, QP, QC, Manufacturing... ensure that mRNA organization meet cGMP and Corporate Standards over the life cycle.
- Document and assess the impact of planned changes to facilities the processes support the quality of the product.
- Lead or support the Quality Management System, Quality Risk Management, Training, Data intelligence...
- Ensure compliance with regulatory guidelines and industry standards, including Good Manufacturing Practices (GMP) and relevant regulations outlined by the FDA and ICH.
- Maintain detailed records to demonstrate proper management of quality, ensuring traceability, accountability, and transparency.
- Support proactively the continuous improvement of the quality accross the mRNA organization.
**Requirements**:
- Currently pursuing a Bachelor's or Master's degree in a relevant field such as Pharmaceutical Industry or a related area.
Equivalent experience will also be considered.
- Strong interest in continuous improvement.
- Pragmatic and focus on easy and simple solution for shopfloor.
- Knowledge of GMP guidelines and regulations is highly desirable.
- Excellent analytical and problem-solving skills, with the ability to interpret and present data effectively.
- Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
- Self-motivated and capable of working autonomously, while also being proactive in collaborating with others.
- Familiarity with production and quality risk management processes.
- Listening, negotiation, and communication skills.
- Oriented towards prioritization and results achievement.
- Experience in Pharma Operations and Quality Units of a pharmaceutical company (at least 5 years).
- Proficiency in English.
Thermo Fisher Scientific is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status.