Shift Lead I, Quality Assurance Job at Baxter (Ahmedabad)

Shift Lead I, Quality Assurance

Baxter

Location:
India , Ahmedabad

Category:
Quality Control

Contract Type:
Not provided

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 monitor various departmental activities (including clean-room behavior) in all three shifts for Quality Oversight
To manage and allocate the shift resources for various activities
To ensure and perform the line clearances of process and packaging activity, in-process checks as per defined frequency, online review of Batch records to ensure compliance and Good documentation practices
To ensure and perform the sampling of finished goods, in-process samples, retain samples, stability & elemental impurity samples, batch testing samples and other samples as required are as per procedure and handed over accordingly
To ensure the review and verification of electronic records/Audit trails and batch related printout of all the equipment as applicable
To overview and ensure the activity are being performed as per the defined procedure for dispensing, mixing process, filtration, filling, capping, terminal Sterilization, visual inspection, packing and dispatch of the batch
To ensure and verify that there shall be no data integrity breach at any stage of the manufacturing and packing process
To ensure and review of the alarms of EMS/BMS system and any other equipment’s if any
To verify the dispatch activity are being performed as per the defined process
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards and all applicable quality standards in the plant
To ensure that every batch of product meets the defined standards for strengths, identity, safety, purity, and quality
To take corrective and preventive actions by performing root cause analysis for complaints and non-conformities to minimize recurrence
To review validation reports, corrective, and preventive action (CAPA) reports and approval of the validation reports, etc.
To take deep dive into problems encountered & discuss the cross functional team to ensure compliance
To conduct the regular shop-floor rounds and report the findings with immediate action taken in the shift to respective functions
To track the CPV Program in MINITAB through provided exhibits and ensure its compliance and escalation of any signals identified
To maintain the admin logins for all applicable equipment’s and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users and review of audit trail reports
To initiate the batch number in BaxLIMS and ensure its correctness
To approve the Workorders/Breakdown reports/ preventive maintenance activities 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 ensure periodic clean room inspection as per approved schedule and its compliance
To ensure the timely removal and destruction of documents as per approved procedure
To carry out reconciliation and physical verification of the returned goods
To escort and engage the personnel from regulatory agencies as per requirements
To support in fetching and compiling data required for during reviewing performance of Quality Assurance at regular frequency by Quality Head
To prepare and review of SOPs pertaining to IPQA and review of SOPs pertaining to cross functional departments
To assess the continuity of the process or activity in consultation with line manager and cross-functional team members for any non-compliances observed
To ensure immediate escalation for any decision needed on key quality or process or operations to the respective functions
To perform the periodic building inspection with Admin team
Any IPQA activity other than mentioned above assigned by reporting manager

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 18, 2026

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Job Link Share:

Shift Lead I, Quality Assurance

Baxter

Location:
India , Ahmedabad

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Requirements:

Additional Information:

Job Posted:
March 18, 2026

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