Supv, QA

**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.

Supervise all IPQA function activity on daily basis and update to QA Head.

Review Master Batch Document (MBD) / Master Packing Document (MPD) and get approval in advance from QA Head and Manufacturing Operation Head.

Ensure training of new procedures and current guidelines is provided to team members after discussion or verification of matter with QA Head.

Review monthly & weekly production & dispatch plan & ensure smooth implementation of the plan in co-ordination with cross functions.

Suggest planning department in advance if any change is required.

Review Good Documentation practice (GDP) or Good Manufacturing Practice (GMP) issues, analyze the impact on the product quality, strength, identity, and efficacy and suggest corrective actions, where necessary.

Conduct daily morning meeting and review weekly or monthly departmental activity and report the same to QA Head.

Approve sample or good destruction process and to review and report any gap to QA Head and take corrective and preventive action in co-ordination with respective functions.

Respond to queries received from international regulatory affairs (IRA) department/business partner/regulatory agency and start change procedure and report the queries and response to QA Head.

Review instrument calibration records & ensure effective investigations done and CAPA taken in case of any abnormality observed.

Conduct and participate in CAPA meetings and review summary report of the same within defined time monthly.

Ensure the implementation of GMP, GDP practices and review of issues and impact of the same, if any and take corrective actions.

Ensure investigation for complaints, out of specification, non-conformity is completed in effective manner, on time and CAPA after reviewing instruments.

Ensure that Document Change Request and Change Control Management closed as per Standard Operating Procedure.

Prepare, review, implement and update SOP’s according to current regulations systems.

Update new procedures and current guidelines or changes in international regulatory requirements.

Ensure and identify, monitor the non-conformity or abnormalities in process or documents or systems are captured and resolve them according to Quality Management System.

To prepare budget for purchase of all the requirements related to IPQA activities.

To accept & approve the new manufacturing & IPQA procedures and approve Standard Operating Procedure (SOPs) by considering regulatory norms.
Compile data required for Management Information System and provide to QA Head.

Communicate about any failure or abnormal notification to QA Head for their attention and seeking for the solution.

**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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