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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