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Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office
Job Description
Job Description
Evaluate manufacturing process documents or equipment cleaning procedures that must be subjected to validation, in order to acquire information for the definition of the protocols and the execution of the process ( both for product manufacturing and aseptic filling (Media fill)) and the cleaning validation of the procedures. Ensure periodic cleaning verification, as per SOPs and regulatory requirements.
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).

Ensure the drafting and/or updating of risk assessments for management of Cross Contamination.
Ensure alignment with internal SOPs, through verification and supervision of the application of procedures of the areas of competence
Validate the manufacturing processes (applying "Lifecycle approach" Stage 2 Process Qualification and Stage 3 Continued Process Verification), cleaning procedures and APS/Media Fill, collaborating with other departments in the operational activities (through oversight during the validation batches, also during the week end if needed) envisaged by the Protocols. Support, in conjunction with other functions, in the drafting and approval of documents relating to new products in the transfer and validation phase. Handle deviations related to validation activities if necessary.
Ensure accurate execution of validation activities, through the accurate collection and accurate analysis of the results genera

Process & Cleaning Validation Specialist - Fixed term (replacement for maternity leave)

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