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You will be updated with latest job alerts via emailThis 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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere your purpose accelerates our mission.
1 To review executed Batch Manufacturing Records and Batch Packing Records.
2 To ensure that every batch record is reviewed for its accuracy completeness and compliance with the established specifications to determine its disposition for release or reject.
3 To review all batch records and data against the requirements of applicable Technical Package SOPs specifications Good Documentation Practices (GDPs) Good Manufacturing Practices (GMPs) and any impact on product quality strength identity safety purity and quality prior to batch disposition.
4 To comply abnormality observed during Batch records review in coordination with respective functions.
5 To ensure that all investigations associated with a batch records review has been completed adequately investigated and closed out prior to the batch disposition.
6 To prepare Batch Release Note once the batch comply with predefined specifications limits and marketing authorization requirement and prepare Batch Rejection note if its not complying.
7 If a nonconforming batch has been determined to be rejected assure appropriate batch labelling has been applied and the batch is moved to the designated area of the warehouse.
8 To ensure current Good Manufacturing Practice (cGMP) standards are followed.
9 To issue and generate rejected label for the rejected batch.
10 To verify reject label audit trail report periodically as per define process. If any discrepancy found inform to Supervisor.
11 To prepare change control management (CCM) or document change request (DCR) for Batch Release related activity.
12 To raise Nonconformance Report (NCR) if any noncompliance occurred during of Batch Release related activity.
13 To prepare review or revise SOPs at regular interval to meet regulatory requirement or complies internal audit observation (if any).
14 To prepare Certificate of Conformity and Certificate of Manufacturing as per the PAC/partner requirement and submit to them.
15 To coordinate with PAC team for QP related query support as per procedure describe in standard operating procedure.
16 To support crossfunctional staff for any Batch records related query resolution.
17 To initiate and implement appropriate corrective and preventive action in coordination with the respective function.
18 To perform task for Corrective Action and Preventive Action as well as for Change Control Management.
19 To submit Batch Release documents to IRA as per requirement and keep supervisor informed for the submission status.
20 To provide entry access to QAoffice and retain sample room and maintain its document.
21 To ensure the sample/batch destruction authorization procedure is performed when required.
22 To prepare timetotime budget for purchase purchase order and good receipt note for all the requirements related to batch release activities.
23 To communicate about any failure or abnormality notification to Supervisor & QA Head for their attention and seeking for the solution.
24 To keep status update of the released/rejected batches and report to Supervisor and QA Head on daily basis.
25 To seek area of improvement from QA Head and prepare implement action plan.
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
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.
Full-Time