Equipment Validation Lead

3 settimane fa

Ferentino, Italia Thermo Fisher Scientific A tempo pieno

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

**How will you make an impact?**

You will join the site Equipment Validation Team, a smart, fast paced and result oriented environment where you will work with mínimal supervision on multiple projects and new products introduction.

**What will you do?**
- Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.
- Draw up Qualification/Requalification Documents (IQ-OQ-PQ Protocols), through the research and acquisition of the data and information necessary to define their contents as well as involving the corporate functions in relation to the definition of the tests they will have to carry out.
- Ensure the accurate qualification/requalification of plant and equipments, through the execution of the operational activities envisaged by the Protocols (IQ-OQ-PQ Protocols) and the coordination of the activities carried out by the other company functions, in compliance with the company protocols and SOP.
- Carry out an accurate analysis of data collected during qualification activities, through the collection of data and the results generated, according to ThermoFisher scientific protocols and standard procedures.
- Issue Qualification Reports (IQ-OQ-PQ Report), based on the accurate analysis of all the data recorded during validation activities, in compliance with company protocols and procedures.
- Carry out the accurate archiving of all the documentation produced during qualifications activities, issuing validation dossiers ensuring their accurate traceability
- Support QA Compliance in preparing for and participating in audits by regulators or customers, providing necessary information and documentation. If requested by QA Compliance, according with the Supervisor, actively participate regulatory or customers audits.

**How will you get here?**
- Degree in CTF, Industrial Chemistry, Engineering or other similar fields
- Experience in pharmaceutical industries
- Multi-year experience in Validation of equipment for Sterile Injectable products

**Knowledge, Skills, Abilities**
- Good knowledge of GMP qualification process and documentation
- Strong written and verbal communication.
- Interpersonal cross functional team based interaction.
- Analytical thinking, planning and problem solving skills

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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