Equipment Validation Specialist
3 settimane fa
Analysis of the technical documentationEnsure, 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 definitionDraw 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.
- QualificationEnsure 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 analysisCarry 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 ReportsIssue 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 dossiersCarry out the accurate archiving of all the documentation produced during qualifications activities, issuing validation dossiers ensuring their accurate traceability
- AuditsSupport 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.
For the role is required:
- At least one year of experience in pharmaceutical industry
- Knowledge of English language
- Good relational skills
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