This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride.
To supervise all IPQA function activity on daily basis and update to QA Head as and when appropriate To ensure the all-time Audit readiness on the Shop floor. To ensure the data integrity is not compromised throughout the manufacturing activities of the Product. To review Master formula record and give feedback to the F&D. To ensure training of new procedures and current guidelines is provided to IPQA team members. To review monthly production plan and to ensure that required support is provided for smooth execution of the plan in co-ordination with cross functions. To suggest planning department in advance if any change is required. To review Good Documentation practice (GDP) or Good Manufacturing Practice (GMP) issues, analyze in coordination with cross-functional team members the impact on the product quality, strength, identity, and efficacy and suggest corrective actions, where necessary. To conduct daily morning meeting and review departmental activities and report to QA Head if any escalations To approve sample and/ or good destruction process and to review and report any gap to QA Head and take corrective and preventive action in co-ordination with respective functions. To respond to IPQA associated queries received from international regulatory affairs (IRA) department/business partner/regulatory agency, initiate change procedure as appropriate and report the queries and response to QA Head. To review and approve the instrument calibration failure records and ensure effective investigations done and CAPA taken in case of any abnormality observed. To review and Approve the CAPA, non-conformance, OOS, OOL investigation report, DCR, CCM and its extension. Participate in CAPA meetings and review summary report of the same within defined time monthly. To review the investigations for market complaint, out of specification, non—conformance investigation is completed in effective manner, on time and appropriately CAPA is established. To ensure that Document Change Request and Change Control documentation owned by IPQA is closed as per Standard Operating Procedure. To review/Approve, implement and update IPQA SOP’s according to current regulations. To update the team about new procedures and current guidelines or changes in international regulatory requirements. To identify, monitor the non-conformity or abnormalities in process or in documents or in systems and ensure that those are captured and resolved according to Quality Management System. To ensure the continuous Audit trail and user access right verification review as per defined schedule. To allocate and monitor work assigned to the team. To prepare budget for purchase of all the requirements related to IPQA activities. To Review and Approval of the BMRs, SOPs, MFR, qualification protocols, miscellaneous protocols, qualification summary reports, CPV reports, APQR reports, CSV protocols and reports, risk assessments, facility drawings, layouts and related documents in TCU. To review and Approve Executed validation documents/ Trends summary reports and any other documents To review and approve miscellaneous study plans/protocols and cross-functional documents including rationale, risk assessments, engineering drawings, layouts. To halt the production in consultation with QA Head, Operations Head or Plant Manager– Manufacturing, if the GMP (Good Manufacturing Practices) requirements are not followed, and the quality is likely to be compromised. To communicate about any failure or abnormal notification (associated with product manufacturing and packaging activities) to QA Head for their attention. To ensure the implementation of audit commitments and its effectiveness. To review and approve the Breakdown Maintenance report of Maximo. To ensure the GQP Assessment and its implementation. To ensure the visual inspection qualification procedure followed as per applicable SOP. To ensure verification of the change parts before commencements of Batch for its cleaning and Physical appearance. To ensure the timely closure of CFS documents. To work as a designee of QA head and responsible for the allocated lines report to the QA Head. Any Other responsibility Assigned by QA head.
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.