Sr Executive I, Quality Systems

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

• To archive master copy and superseded copy of documents in documents record room.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 To destroy the submitted superseded controlled copies to maintain records.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 Procedure (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.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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