Equipment Validation Specialist

4 settimane fa

Ferentino, Italia TN Italy A tempo pieno
Client:

Thermo Fisher Scientific

Location:Job Category:

Other

EU work permit required:

Yes

Job Reference:

3f55817ee794

Job Views:

11

Posted:

11.02.2025

Expiry Date:

28.03.2025

Job Description:

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.

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 equipment, 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 Thermo Fisher 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 to the Supervisor, actively participate in regulatory or customer audits.

Minimum Requirements:

  • At least one year of experience in the pharmaceutical industry

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