Support the management of quality system documents and the archiving activities. Management of Site archival and support for the issuance of Batch Records issuance and all related documentation, SOPs and training records.
About the Role· Management of the Site Archival with proper filing activities, documents identification and location management of the storage spaces.
· Is responsible for the archive housekeeping and prompt documents recovery.
· Interact with the external archival services for the transfer and recovery of documentation.
· Support the Quality Assurance Assistant team for any required documentation activity.
· Collaborate with the Function Manager in order to guarantee the correct management of the original documents.
· In collaboration with the Function Manager, follow the approval flow of procedures in the electronic system ESOPS.
· Provide for the distribution of the authorized copies and the removal of obsolete original documents and the correct management of the draft documents.
· Update the Quality System documentation lists.
· Collaborate with the Function Manager in order to guarantee the correct coding system of the Quality System documents.
· Collaborate with the Function Manager in order to continuously guarantee the degree of updating of the Quality System.
· Collaborate with the Function Manager in the management and updating of internal documentation and of external origin involved in the job orders.
· Collaborate with the responsible functions involved in order to guarantee the continuous updating of the documentation attesting the training of the personnel.
· Collaborate with the responsible functions in order to guarantee the continuous updating
of the production worksheets.
· Prepare and print of batch documentation
· Collaborate with Logistic and Supply Chain Departments in the check of the planning before finalization and printing
· Management of artwork approval and archive of performed test
· Reconciliation of the batch record in all sections (production, quality control, shipping, final release)
· Review of all logbooks received from the other Departments before the archive
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Division Operations
Business Unit Innovative Medicines
Location Italy
Site Ivrea
Company / Legal Entity IT58 (FCRS = IT058) AAA Italy Srl.
Functional Area Quality
Job Type Full time
Employment Type Temporary (Fixed Term)
Shift Work No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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