Equipment Qualification Compliance Expert

1 giorno fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Company Overview

We are Thermo Fisher Scientific, a leading global supplier of analytical instruments and equipment. Our mission is to enable our customers to make the world healthier, cleaner and safer.

Job Description

We are seeking an experienced Equipment Qualification Compliance Specialist to join our team. As an Equipment Qualification Compliance Specialist, you will be responsible for ensuring that all equipment meets quality standards and regulations.

Main Responsibilities:

  • Collaborate with Technical Services to ensure that equipment validation and calibration activities meet cGMP and Corporate Standards over the life cycle.
  • Ensure that any planned changes to the facilities, equipment and utilities, which may affect the quality of the product, are formally documented and the impact on the validated status or control strategy is assessed.
  • Promote proper and proactive business partnership with Technical Services Qualification and Calibration system Support Technical Services Group to ensure that decisions on the scope and extend of qualification are based on a justified rationale and, if necessary, on risk assessment of the facilities, equipment, utilities and processes.
  • All documents generated during qualification and calibration are approved and authorized by appropriate personnel as defined in the pharmaceutical quality system.
  • All qualification and calibration activities are planned and take the life cycle of facilities, equipment, utilities, process and product into consideration.
  • Qualification and Calibration activities to ensure that proper planning of qualification activities is respected by attending project plan meetings and sharing needs and expectations for full compliance.
  • Change control and deviation management for qualification and calibration is performed according to cGMP and Corporate Standards.
  • Support the relevant departments to ensure that the specification for equipment, facilities, utilities or systems are defined in a URS and/or a functional specification.
  • If needed, participate to Factory acceptance testing /Site acceptance testing/ Design Qualification/ Installation Qualification/ Operational Qualification /Performance Qualification activities.

Requirements

  • CTF/Pharma degree
  • 2/3 years of experience in pharma industry and in validation field
  • Good knowledge of Italian and English language (level B2) written and spoken

Estimated Salary: $80,000 - $110,000 per year, depending on experience.



  • Monza, Lombardia, Italia Mygwork A tempo pieno

    At Thermo Fisher Scientific, we are dedicated to making the world healthier, cleaner, and safer through our innovative technologies and industry-leading brands. We invite you to join us in this mission as a GMP Equipment Compliance Specialist.About UsThermo Fisher Scientific is an inclusive employer and a member of Mygwork – the largest global platform for...


  • Monza, Lombardia, Italia Mygwork A tempo pieno

    About the RoleWe are seeking a Quality Assurance Specialist to join our team in Monza, Italy. As a Quality Assurance Specialist, you will play a crucial role in ensuring the compliance of our mRNA site with quality regulations.Job DescriptionThis is an exciting opportunity to contribute to the general compliance of our mRNA site and ensure that our company...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Compliance Expert to join our team at Thermo Fisher Scientific. This is an exciting opportunity to work in a newly-established mRNA GMP manufacturing facility in Monza, Italy.ResponsibilitiesAdvise on licensing strategies for innovative mRNA products and partner with the Qualified Person to ensure...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Company Overview">The QC Equipment Calibration team is seeking a dedicated Coordinator to provide additional value in the Quality Control Function. As a QC Equipment Calibration Coordinator, you will join the QC Equipment Calibration team, working to guarantee the correct calibration and maintenance status of the QC laboratories equipment of DPS QC...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About Thermo Fisher ScientificWe are a leading provider of innovative solutions in the life sciences industry.Estimated Salary: $80,000 - $110,000 per yearJob DescriptionCompany OverviewThermo Fisher Scientific Inc. is a multinational biotechnology product development company that offers a range of products and services to help our customers advance their...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    **Job Overview**We are seeking a highly skilled Gmp Documentation Specialist to join our team at Thermo Fisher Scientific. As a key member of our Quality Assurance department, you will play a crucial role in ensuring the accuracy and compliance of all documentation related to Good Manufacturing Practices (GMP) and quality assurance.**Estimated Salary:**...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Role OverviewThermo Fisher Scientific Inc. is seeking a highly motivated Quality Compliance Senior Manager to join our team in Italy. The successful candidate will play a key role in ensuring site operations meet cGMP and regulatory compliance while maintaining our commitment to exceptional quality standards.Key Responsibilities• Support and facilitate the...

  • IT Compliance Expert

    4 settimane fa


    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job OverviewWe are seeking a highly skilled IT Compliance Specialist to join our PSG IT Core Services Team. This role involves delivering solutions and support in partnership with local and global functions, driving efficient and compliant technology solutions.Key Responsibilities:Ensure operational compliance of IT systems.Collaborate with global teams to...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    **Job Summary:**We are seeking an experienced Pharmaceutical Development Proposal Expert to join our team at Thermo Fisher Scientific. The successful candidate will be responsible for developing and executing proposal strategies that meet or exceed client expectations, while ensuring compliance with regulatory requirements.Key Responsibilities:- Develop and...


  • Monza, Lombardia, Italia F. Hoffmann-La Roche Ag A tempo pieno

    About UsF. Hoffmann-La Roche Ag is a leading research-focused healthcare group with over 100,000 employees worldwide. We are passionate about delivering medical solutions and transforming patients' lives.Job DescriptionWe are seeking a Strategic Procurement Development Expert to join our team in Italy. As a key member of the Procurement department, you will...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job SummaryWe are seeking a highly skilled Quality Services Supervisor to join our team at the new mRNA GMP facility in Monza. As a key member of our quality services team, you will be responsible for providing strategic advice on quality regulations and ensuring compliance with laws, GMP, and FDA standards.Key ResponsibilitiesLead quality audits from...


  • Monza, Lombardia, Italia Mygwork A tempo pieno

    Thermo Fisher Scientific is an inclusive employer and a member of Mygwork – the largest global platform for the LGBTQ+ business community. We're seeking a Quality Vendor Management Specialist to join our team in Monza, Italy.About the RoleThis is a unique opportunity to work in a new mRNA GMP facility and contribute to the general compliance of the site....


  • Monza, Lombardia, Italia Tetra Pak A tempo pieno

    Secure a challenging role as a Senior Automation Systems Specialist with Tetra Pak, a leading provider of processing, packaging, and distribution solutions for the food industry. As a key member of our team, you will be responsible for providing expert support in the installation, commissioning, and maintenance of automation systems on food processing...


  • Monza, Lombardia, Italia Chart Cooler Svc Co Inc A tempo pieno

    Job OverviewThe Senior Operations Director will play a critical role in implementing business strategies, improving performance, and ensuring compliance across all levels of the organization. This leader will supervise Engineering, Project Management, and Manufacturing Departments, which operate in the design and manufacture of pressure equipment for various...

  • High-Speed Test Engineer

    4 settimane fa


    Monza, Lombardia, Italia Alfa Laval Corporate Ab A tempo pieno

    **About Alfa Laval Corporate Ab**Alfa Laval is a Swedish multinational company with over 100 years of experience in Italy, operating through multiple sales offices, manufacturing sites, and research facilities. We strive to deliver exceptional results for our customers, people, and the planet.The Role:We are seeking a talented RD Test Engineer to join our...


  • Monza, Lombardia, Italia Thermo Fisher Scientific Inc. A tempo pieno

    Thermo Fisher Scientific Inc. is a world-class leader in the pharmaceutical industry, and we are seeking a highly skilled Sr Formulation Technician to join our team.About the RoleWe are looking for an experienced professional with a strong background in pharmaceutical production, particularly in manual, semi-automatic, or automatic inspection. The ideal...


  • Monza, Lombardia, Italia F. Hoffmann-La Roche Gruppe A tempo pieno

    Roche Diagnostics Italy fosters diversity, equity, and inclusion in the global healthcare sector. A diverse workforce is essential to success in understanding varied healthcare needs. We believe that inclusion is key to delivering exceptional care. At Roche, every voice matters.The PositionYou will join the Procurement department of Roche Diagnostics Italy...


  • Monza, Lombardia, Italia Alfa Laval Corporate AB A tempo pieno

    Company Overview:Alfa Laval Corporate AB is a Swedish multinational company operating in Italy for over 100 years with several sales offices, manufacturing and research and development. Our driving force is to accelerate success for our customers, people and planet.About the Job:We are looking for a person with creative problem-solving and troubleshooting...

  • Analytical Chemist

    6 giorni fa


    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About Thermo Fisher ScientificThermo Fisher Scientific is a world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer.Your Future RoleIn this role as an Analytical Chemist, you will work within the mRNA Process & Analytical Method Development Group contributing to developing analytical methods,...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About UsThermo Fisher Scientific is a leading provider of innovative solutions for life sciences, healthcare, and education. Our mission is to enable our customers to make the world healthier, cleaner, and safer.Job DescriptionWe are seeking a highly experienced Senior Quality Assurance Manager to lead our newly established team responsible for cGMP...