Sr Executive I, Quality Assurance Job at Baxter (Ahmedabad)

Job Description

Aquí es donde usted marca la diferencia en la seguridad de nuestros pacientes. Como miembro del equipo de Calidad de Baxter, desempeñará un papel esencial en nuestra misión de salvar y sostener vidas. La calidad es importante durante todo el ciclo de vida del producto y trabaja en colaboración con todas las áreas de la organización. Debido a que Calidad afecta todo lo que hace Baxter, un rol en Calidad brinda muchas oportunidades de crecimiento, aprendizaje y una carrera exitosa que tiene un impacto diario en la vida de las personas.

Job Responsibility

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment's like autoclave, sterilizer, filter integrity machine and any other equipment's etc
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline
To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure
To prepare and review the SOPs
To carry out stagewise BMR review for batch execution compliance
To track the CPV Program through provided exhibits and to prepare the Minitab files for required products based on production plan for the month
To collect the data related to CPPs/ CQAs and shall perform data analysisy
Report any abnormality gap to supervisor /Shift lead
To maintain the admin logins for all applicable equipments and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users
Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required
To approve the 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 communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution
To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review
Material A.R.No. Stock Blockage or Un-blockage in System
To perform the periodic building inspection with Admin team
Any other responsibility assigned by shift lead and reporting manager

Requirements

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment's like autoclave, sterilizer, filter integrity machine and any other equipment's etc
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline
To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure
To prepare and review the SOPs
To carry out stagewise BMR review for batch execution compliance
To track the CPV Program through provided exhibits and to prepare the Minitab files for required products based on production plan for the month
To collect the data related to CPPs/ CQAs and shall perform data analysisy
Report any abnormality gap to supervisor /Shift lead
To maintain the admin logins for all applicable equipments and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users
Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required
To approve the 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 communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution
To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review
Material A.R.No. Stock Blockage or Un-blockage in System
To perform the periodic building inspection with Admin team
Any other responsibility assigned by shift lead and reporting manager

What we offer

Apoyo a las padres
Educación continua/ Desarrollo profesional
Salud de los empleados y Beneficios de bienestar
Tiempo libre pagado
2 días al año para ser voluntario

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Sr Executive I, Quality Assurance

Job Description

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Requirements

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