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Shift Lead I, Quality Assurance

https://www.baxter.com/ Logo

Baxter

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Location:
India , Ahmedabad

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Contract Type:
Not provided

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Salary:

Not provided

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:

  • Make a difference in patients’ safety
  • Play an essential part in mission of saving and sustaining lives
  • Work collaboratively with all areas of the organization
  • Provide many opportunities for growth, learning and a successful career that has a daily impact on people’s lives

Requirements:

  • Monitor various departmental activities (including clean-room behavior) in all three shifts for Quality Oversight
  • Manage and allocate shift resources
  • Ensure and perform line clearances of process and packaging activity, in-process checks, online review of Batch records
  • Ensure and perform sampling of finished goods, in-process samples, retain samples, stability & elemental impurity samples, batch testing samples
  • Ensure review and verification of electronic records/Audit trails and batch related printout of equipment
  • Overview and ensure activities are performed as per defined procedure for dispensing, mixing, filtration, filling, capping, terminal Sterilization, visual inspection, packing and dispatch
  • Ensure and verify no data integrity breach at any stage of manufacturing and packing
  • Ensure and review alarms of EMS/BMS system and other equipment
  • Verify dispatch activity is performed as per defined process
  • Ensure implementation and maintenance of current Good Manufacturing Practice (cGMP) standards and all applicable quality standards
  • Ensure every batch meets defined standards for strengths, identity, safety, purity, and quality
  • Take corrective and preventive actions by performing root cause analysis for complaints and non-conformities
  • Review validation reports, corrective, and preventive action (CAPA) reports and approval of validation reports
  • Take deep dive into problems encountered & discuss with cross functional team
  • Conduct regular shop-floor rounds and report findings
  • Track CPV Program in MINITAB and ensure compliance and escalation of any signals
  • Maintain admin logins for equipment, provide new logins, activation & deactivation for users, periodic verification & access control, review audit trail reports
  • Initiate batch number in BaxLIMS and ensure correctness
  • Approve Workorders/Breakdown reports/ preventive maintenance activities in MAXIMO and risk assessment review and approval
  • Ensure handover of shift-to-shift activities
  • Ensure periodic clean room inspection
  • Ensure timely removal and destruction of documents
  • Carry out reconciliation and physical verification of returned goods
  • Escort and engage personnel from regulatory agencies
  • Support in fetching and compiling data for reviewing performance of Quality Assurance
  • Prepare and review SOPs pertaining to IPQA and review SOPs pertaining to cross functional departments
  • Assess continuity of process or activity in consultation with line manager and cross-functional team for any non-compliances
  • Ensure immediate escalation for any decision needed on key quality or process or operations
  • Perform periodic building inspection with Admin team
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 20, 2026

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