Associate QA Ipqa

4 weeks 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 take instructions from Supervisor and shift lead to perform the shift activity. 2.2 To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records. 2.3 To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR. 2.4 To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place. 2.5 To collect In-process samples, finished product samples, and other samples timely submission into QC/micro. 2.6 To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine and any other equipment’s etc. 2.7 To ensure the respective documents to be destructed as per approved procedure. 2.8 To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured. 2.9 To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification. 2.10 To execute the approved Corrective and Preventive Action (CAPA) with in define timeline. 2.11 To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure. 2.12 To prepare and review the SOPs. 2.13 To carry out stagewise BMR review for batch execution compliance. 2.14 To track the CPV Program through provided exhibits and to prepare the Minitab files for required products based on production plan for the month. To collect the data related to CPPs/ CQAs and shall perform data analysisy. Report any abnormality gap to supervisor /Shift lead. 2.15 To maintain the admin logins for all applicable equipments and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users. 2.16 Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required. 2.17 To approve the preventive maintenance activities in MAXIMO and risk assessment review and approval. To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook. 2.19 To communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution. 2.20 To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review. 2.21 Material A.R.No. Stock Blockage or Un-blockage in System. 2.22 To perform the periodic building inspection with Admin team. 2.23 Any other responsibility assigned by shift lead and reporting manager.

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**Reasonable Accommodations**

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