Assoc, Quality Assurance

2 months ago

Ahmedabad, 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 to manage shift activity. To verify raw material at the time of dispensing against BMR or Standard Format approve the process step.
- To perform routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities and if any deviation or abnormal observation in terms of noncompliance to Good Manufacturing Practice (GMP) observed, bring to the notice of Supervisor.
- To ensure that finished product samples are collected from defined location after that perform visual inspection from authorized visual inspector and perform leak test and submit it to QC & Micro.
- To help Supervisor in preparation, review, implement and update SOP’s according to current regulations systems.
- To provide line-clearance for routine manufacturing activity and dispensing activity, monitor each line & sample collection at regular interval.
- To carry out stagewise BMR review for batch execution compliance.
- 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 /QA Head and take corrective and preventive action in coordination with respective functions.
- 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. Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required. To Perform impact assessment of breakdown maintenance and approve activity 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.
- To perform periodic Clean room inspection and ensure its compliance. In case of any product complaints or non-conformities provide support to Supervisor in investigation.
- To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS), as per instruction of Supervisor. Material A.R.No. Stock Blockage or Un-blockage in System.
- To give non-compliance reports to the respective departments in case of internal quality audits and report it to Supervisor and QA Head.
- To communicate about any failure or abnormal notification to Supervisor & QA Head for their attention and seeking for the solution.
- To seek area of improvement from QA Head and implement action plan.

**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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