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Sr Executive I, Quality Assurance

https://www.baxter.com/ Logo

Baxter

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Location:
India , Ahmedabad

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Requirements:

  • To take instructions from supervisor or QA Head to manage Document Control activity
  • To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards
  • To review and verify that any GDP issues have been addressed
  • To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS)
  • To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room
  • To issue completed records from record room and ensure its storage, achieve & timely disposition
  • To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products)
  • To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement
  • To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site
  • To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment
  • To review departmental Standard Operating Procedure and keep it updated by providing inputs for IPQA functions as per regulatory guidelines
  • To maintain Bill of material, Creation of HALB code in JDE
  • To review cross-functions Standard Operating Procedure and keep it updated by providing inputs for Document Control functions as per regulatory guidelines
  • To prepare annual product review report and submit to IRA for dossier updation
  • To prepare change control management (CCM) or document change request (DCR) for Document Control
  • To raise Non-conformance Report (NCR) and complete investigation report with appropriate correction and/or preventive actions if any non-compliance occurred during execution of Document Control activity
  • To perform execution task for Corrective Action and Preventive Action
  • To perform execution task for Change Control Management
  • To prepared, review or revised SOPs at regular interval to meet regulatory requirement or complies internal audit observation (if any)
  • To support cross-functional department staff for any Batch records related query resolution
  • To generate and review stability intimation slip in ELN
  • To seek area of improvement from QA Head and implement action plan
  • To communicate any failure or abnormal notification to Supervisor and QA Head for their attention and seeking for the solution
  • To communicate any gap or abnormality observed during data verification to Supervisor or QA Head
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 13, 2026

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