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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Requirements:
To archive master copy and superseded copy of documents in documents record room
To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP
To ensure proper storage and archival of documents in the Central record room
To maintain documents inventory for record room and to intimate the document owner on the due date of document retention period which is going to get due
To ensure access of central record room and BaxCabinet access for document process to required person as per request
To ensure departmental NCR initiate on time and prepare investigation report for NCR
To ensure closure of DCR/CCM/NCR/CAPA task within time frame
To ensure that all document records for doc-cell are in line with cGMP and regulatory compliance
To issue controlled copies of documents to the copyholders
To maintain blank logbook inventory and issue logbook and daily notebook based on request
To destroy the submitted superseded controlled copies to maintain records
To update SOP index every month and to prepare/update departmental Standard Operating Procedures (SOPs)
To review and release and set effective date of documents in TcU and to link new documents in respective department in CFS and close used documents in CFS
To generate reports of open form in CFS and provide status to HOD
To block / unblock item code as per request
To ensure alignment of Global procedures (GQP/ GQR) with site Document control procedure
To ensure TcU training program are imparted to the site users
To train and monitor TcU activity to all the users
To represent the department in all audits/ inspections from time to time and to ensure completion of the associated actions
To ensure documents processed in TcU for Baxter Ahmedabad plant have proper metadata as per SOP and documents effective as per timeline
To monitor CFS and TcU related issue and escalate to management