Quality Equipment & Software Compliance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Discover Impactful Work:

As a Quality Equipment & Software Compliance 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 equipment and software qualification compliance.

Responsibilities:

• Conduct thorough assessments and tests to verify the suitability, reliability, and performance of equipment and software used in GMP manufacturing and testing.
• Collaborate with Technical Services to ensure that equipment and software validation and calibration activities meet cGMP and Corporate Standards over the life cycle.
• Document and assess the impact of planned changes to facilities, equipment, software, and utilities on the quality of the product.
• Participate in Factory acceptance testing, Site acceptance testing, Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification activities.
• 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 qualification of equipment and software, ensuring traceability, accountability, and transparency.

Requirements:

• Currently pursuing a Bachelor's or Master's degree in a relevant field such as Industrial Engineering or a related area. Equivalent experience will also be considered.
• Strong interest in equipment and software qualification principles to improve operational efficiency and compliance in a GMP environment.
• 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.
• Pragmatic and oriented towards prioritization and results achievement.
• Experience in Pharma Operations and Quality Units of a pharmaceutical company (at least 5 years).
• Proficiency in English.

Join us in our supportive and collaborative work environment that fosters professional growth and learning. At Thermo Fisher Scientific, we are dedicated to making the world healthier, cleaner, and safer through our innovative technologies and industry-leading brands. Apply today to start your story with us!

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.