At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Responsibilities:
- Monitor various departmental activities (including clean-room behavior) in all three shifts for Quality Oversight.
- Manage and allocate shift resources for various activities.
- Ensure and perform line clearances of process and packaging activity, in-process checks, online review of Batch records, and compliance with Good documentation practices.
- Perform sampling of finished goods, in-process samples, retain samples, stability & elemental impurity samples, and batch testing samples as required.
- Review and verify electronic records/Audit trails and batch-related printouts of all equipment as applicable.
- Ensure activities are performed per the defined procedures for dispensing, mixing process, filtration, filling, capping, terminal sterilization, visual inspection, packing, and dispatch of the batch.
- Review validation reports, corrective and preventive action (CAPA) reports, and approve validation reports.
- Conduct regular shop-floor rounds and report findings with immediate action taken in the shift to respective functions.
- Maintain admin logins for all applicable equipment and provide new logins, activation & deactivation for users, periodic verification & access control of all users, and review of audit trail reports.
- Ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook.
- Ensure periodic clean room inspection as per approved schedule and its compliance.
- Perform the periodic building inspection with the Admin team.
- Any IPQA activity other than mentioned above assigned by the reporting manager.
