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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