Sr Exec, Quality Assurance

1 week ago

ahmedabad, India Baxter Full time

This is where you save and sustain lives

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.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

2.1 To execute in-process quality assurance activities as delegated by Supervisor and/or shift lead in each shift. 2.2 To perform the line clearance activity at various stages of packaging activity as defined in the Batch Packaging record. 2.3 To perform routine in-process checks, online documentation as defined in batch packing records at visual and packing stage and escalate any non-conformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place. 2.4 To check and ensure challenge test performed at defined frequency for applicable packaging equipment’s. 2.5 To collect the stability sample/Retain Sample/other samples and records the collection detail in BPR and ELN. 2.6 To verify sample / good destruction process and report any gap to Shift Lead or Supervisor and to take corrective and preventive action in coordination with respective functions. 2.7 To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured and packed in the plant and data integrity is ensured. 2.8 To perform Acceptance Quality Limit (AQL) of visually inspected product. 2.9 To verify and approve pallet planning approval in PCR system at dispatch area. 2.10 To ensure cGMP compliance during packing and visual inspection process. 2.11 To perform, evaluate and carry out Visual Inspection qualification process. 2.12 To prepare and maintain visual inspection qualification kit and record. 2.13 To carry out stagewise BPR review for batch execution compliance. 2.14 To review and verification of user access management and Audit trail. 2.15 To perform and support in the CPV programme. 2.16 To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook. 2.17 To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review. 2.18 To participate in investigation, in case of any complaints or non-conformity. 2.19 To communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution. 2.20 To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure. 2.21 Any other responsibility assigned by shift lead and reporting manager.

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