Quality Equipment Specialist

5 ore fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Job Summary

We are seeking a highly skilled Quality Equipment Specialist to join our team at Thermo Fisher Scientific. As a Quality Equipment Specialist, you will play a critical role in ensuring the compliance of our mRNA GMP facility in Monza with quality regulations, including laws, GMP, FDA, and ATMP.

Key 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.

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