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.
Requirements
Successful candidate will have strong skills in the following areas:
- Strong written and verbal communication.
- Interpersonal cross functional team based interaction.
- Organizational and detail orientation.
- nalytical thinking, planning and problem solving.
- Should also be intellectually curious and results oriented.
- Proven experience in a pharmaceutical environment is required. (Engineering or pharmaceutical chemistry)
