Assoc I, Quality Assurance Job at Baxter (Ahmedabad)

Assoc I, Quality Assurance

Baxter

Location:
India , Ahmedabad

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

Save Job

Apply Position

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.

Job Responsibility:

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

Requirements:

B.Pharma
Exp- 3-7Yrs

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:
February 06, 2026

Baxter - All Job Offers

Job Link Share: