Job Description

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.


2.1 To ensure continuous review of analytical documents generated during the analysis of QC, Stability and Microbiology for adequacy and accuracy.

2.2 To ensure the conformance through review of sample audit trails at the time of batch release for PM, RM In-process, and finished product.

2.3 To ensure the conformance through review of analytical documents in LIMS and release raw material and finished product in JDE.

2.4 To ensure the correctness of the data through periodic review of audit trails for the systems in the laboratory and manufacturing area.

2.5 To ensure the compliance of applicable procedures during analysis as well as 21 CFR part 11 in software and handle the observations through QMS.

2.6 To ensure the review of daily and periodic calibrations, method transfer documents and work orders in Maximo and handle the observations through QMS.

2.7 QA oversight on batch charging for stability studies.

2.8 To review and ensure that periodic withdrawal of stability samples, excursions of temperatures from the incubators are carried out.

2.9 Review of audit trails of manufacturing, packing equipment (PLC/SCADA systems) and computer systems available in engineering, utilities, and store.

2.10 To investigate any Out of specifications (OOS) or Non-conformity Report or Laboratory Incident and take the corrective and preventive actions (CAPA) if required.

2.11 To train team members on current good manufacturing practices (GMP), Good Documentation Practices and good laboratory practice (GLP).

2.12 To approve and ensure the investigation of all QMS elements and related corrective and preventive action as per approved procedure.

2.13 To approve Document change requests and ensure that Document Change requests are closed as per Standard Operating Procedure

2.14 To support & guide team members in implementing change control, corrective, and preventive actions (CAPA) and check efficiency of CAPA, give suggestions wherever necessary.

2.15 To ensure the implementation of current Good Manufacturing Practices, Good Documentation Practices and Good Laboratory Practices norms in Laboratory.

2.16 To take suggestions from QA Head regarding CAPA (Corrective and Preventive Action) as per requirement and ensure its implementation within stipulated timeframe and efficiency of CAPA.

2.17 To review and approve SOP from time to time and suggest and implement changes.

2.18 To support QC doc cell team to resolve specification and MOA queries.

2.19 To review and approve Specification, Standard Test Procedure (STP) and Calculation sheet in TcU.

2.20 To ensure that all Specification related documents and records are in line with cGMP and regulatory compliance.

2.21 To review and approve of method validation/method transfer documents in TcU generated from ADL.

2.22 To participate in management review meeting.

2.23 In the absence of Manager, QA Head will ensure these roles and responsibilities.

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.

Recruitment Fraud Notice



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