Associate Quality

6 months ago

Ahmedabad Gujarat, India BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
- To prepare specifications, Standard Test Procedure (STP) and formats for Certificate of Analysis (COA), Analysis report and Calculation sheet based on reference ADL documents.
- To update addendum of index for new specification and update Specification index on quarterly basis.
- To provide COA based on QC requirement.
- To initiate DCR/CCM for updating of specification, Standard Test Procedure (STP) and calculation sheet.
- To ensure availability of updated calculation sheet in Controlled Form System.
- To archive Master copy and Superseded copy of documents in Documents record room.
- To approve QA information request in SAP for new material code.
- To initiate departmental NCR and prepare investigation report.
- To close DCR/CCM/NCR/CAPA task on timely manner.
- To ensure that all document records are in line with cGMP and regulatory compliance.
- To issue controlled copies of documents to the copy holders.
- To maintain Blank logbook inventory and issue logbook based on request for Central department.
- To update SOP index every month.
- To destroy the submitted superseded controlled copies to maintain records.
- To prepare/update departmental Standard Operating Procedure (SOPs).
- To approve material code/HALB code/FERT code in SAP.
- To provide new departmental code if required as per SOP.
- To issue daily notebook to HOD based on request.
- To review and release and set effective date of documents in TcU
- To provide Training for new TcU user.
- To create new CFS user.
- To link new documents in respective department in CFS.
- To close used documents in CFS.
- To generate reports of open form in CFS and provide status to HOD.
- To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP.
- To intimate the document owner on the due date of document retention period which is going to get due.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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