Sr Exec I, Quality Assurance

Ahmedabad - India

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

2.1 To take instructions from Supervisor and shift lead to perform the shift activity.

2.2 To verify the correct raw material primary packaging material and Quantities are issued and dispensed as per the approved Batch records.

2.3 To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR.

2.4 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.

2.5 To collect In-process samples finished product samples and other samples timely submission into QC/micro.

2.6 To review and verification of electronic records/Audit trails and printout of the equipments like autoclave sterilizer filter integrity machine and any other equipments etc.

2.7 To ensure the respective documents to be destructed as per approved procedure.

2.8 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.

2.9 To ensure & provide support to Shift Lead or Supervisor in investigation in case of any product complaints or non-conformities or Out of Specification.

2.10 To execute the approved Corrective and Preventive Action (CAPA) with in define timeline.

2.11 To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure.

2.12 To prepare and review the SOPs.

2.13 To carry out stagewise BMR review for batch execution compliance.

2.14 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.

2.15 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.

2.16 Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required.

2.17 To approve the preventive maintenance activities in MAXIMO and risk assessment review and approval.

2.18 To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook.

2.19 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 . 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.

2.20 Handling all activities pertaining to visual inspection

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.

Required Experience:

Senior IC

This is whereyour work makes a difference.At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater ...