Equipment Validation Specialist

1 mese fa

Ferentino, Italia Thermo Fisher Scientific A tempo pieno

Analysis of the technical documentation

Ensure, in agreement with the Supervisor, 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.

Protocol definition

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.

Qualification

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.

Data analysis

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.

Qualification Reports

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.

Archiving of qualification dossiers

Carry out the accurate archiving of all the documentation produced during qualifications activities, issuing validation dossiers ensuring their accurate traceability

Audits

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.

Minimum requirements for candidates:

- The candidate must have a minimum of one year of experience in the equipment qualification sector,

- Good knowledge of the English language.

- Curious personality oriented towards continuous improvement.

- A degree in scientific subjects.

- Ability to work in a team.

  • Equipment Validation Lead

    1 mese 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 Lead

    1 mese fa

    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Job tasks**: **Analysis of the technical documentation**: 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. **Protocol...

  • Process & Cleaning Validation Specialist Ii

    1 mese fa

    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    Draft of Validation Protocols (cleaning, Process, Media Fill), by acquiring information from other departments to define their contents (e.g. process parameters, sampling plan) as well as collaborating with company functions to define actions to be carried out, as per company procedures. Handle periodic cleaning validation and aseptic fillings (Media Fill)....

  • Pds Analytical Development

    1 settimana fa

    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    According to the tasks received from the manager, yoou will perform the activities listed for which the employee has been enabled by appropriate training, in compliance with Corporate and departmental SOPs and safety regulations. ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES: - uses and controls equipment for analysis in the laboratory. - deals with the...