108 Trackwise Jobs - Page 5

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. To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification. To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Supervisor regarding any non-conformity from planning and execution. To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Supervisor and approved by Manager. To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Trackwise. To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date. To ensure samples withdrawal during process validation & keep Supervisor updated about any non-conformity. To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents. To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by Supervisor. To attend trainings of each protocol before execution of any validation and qualification activity. To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA. To update the protocols as per current regulatory requirement to improve the validation documents. To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Supervisor for review & approve. To keep the validation document updated from GMP aspect as per regulatory expectation. Planning and execution of validation activities associated with QMS elements. To inform the activity or issues which might occurred during the shift's validation activities through daily meeting. To review and approve the documents related to Validation activities and other documents related to Operation. To assist/participate during internal or external inspection. Timely completion of assigned trainings. To be vigilant for safety aspects and record hazard or any near miss in the provided portal. Any additional responsibility as assigned by the Supervisor. 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.

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. To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification. To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Supervisor regarding any non-conformity from planning and execution. To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Supervisor and approved by Manager. To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Trackwise. To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date. To ensure samples withdrawal during process validation & keep Supervisor updated about any non-conformity. To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents. To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by Supervisor. To attend trainings of each protocol before execution of any validation and qualification activity. To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA. To update the protocols as per current regulatory requirement to improve the validation documents. To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Supervisor for review & approve. To keep the validation document updated from GMP aspect as per regulatory expectation. Planning and execution of validation activities associated with QMS elements. To inform the activity or issues which might occurred during the shifts validation activities through daily meeting. 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.

Job Title - Lead- SAP Quality Management (SAP QM) Experienced Required- 8-12 Years Role Description: This role shall support global supply chain business team n various areas such a Supply Chain, Logistics, Shipping, inventory Management, Production Supply and related processes The applicant should also have broad knowledge of SAP The applicant should have the ability to support advanced business functions, translate complex business requirements into solution designs, and build and implement systems and technical solutions for operations. Job Requirements: Around 8+ years of experience in the SAP supply chain focused on SAP ERP design, implementation (at least 3 end to end implementation project) and support Business Process Knowledge of topics viz. Quality Planning, Quality inspection, Quality Control, Quality certificates Quality Notifications Stability Studies, Batch Management etc. Experience of integrating SAP QM with External system 3PLs like MES, Trackwise, LIMS, Labware, Lab Vantage etc, and with other SAP modules, GXP and SOX requirements Experience as Solution Architect in the multiple programs of global scae Experience in Business Blue Printing, Design, Prototyping, Functional Analysis, Configuration, Gap Analysis, Conversion Migration Testing Training Cutover, Go-Live and Post Go-live Support activities, driving Business process workshops and Fit/GAP analysis Deep Knowledge and expertise in Quality Management BPML Good experience in Data migration process and ETL Tools Domain experience in Quality Management with S/4HANA certification (preferred). Experience in Deal Pricing Transformation Deal Estimations Should have experience of Change Management, Task Planning, Project Reporting, Resource Management, Process improvement, Supervising. Strong relationship building skills Job Responsibilities : Establish relationships with Supply Chain (primarily Logistics, Warehouse, Shipping but also other Operations functions and Quality) and super users globally. Lead the engagement efforts at different stages from Problem definition to diagnosis to solution design, development deployment, contribute to unit level Organizational initiatives Design, Build Optimize End to End SAP Quality Management Processes for customers enterprise. Collaborate with business users in Supply Chain Dept. and other departments when needed, to gain a deep understanding of their business processes and requirements. Design, develop and test system solutions to address business requirements, in alignment with the global solution template. Collaborate with business teams globally to gain a deep understanding of business processes, requirements and develop test the processes to address business requirements. Develop functional specifications for custom developments and collaborate with the development team to get those built and tested.

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. The person will be responsible for the execution and analysis of analytical work (Method development, and development stability sample analysis) performed at Analytical Development Laboratory, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites. Quality:  To understand the project in the guidance of Sub-department Manager and follow their instructions.  To perform the analysis under the supervision of Sub-department Manager.  To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed.  To operate and calibrate the instruments as per approved standard operating procedure.  To keep track of each activity related to product analysis and development activities.  To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.  To make entry in respective logbook, when start the analysis and at completion of analysis.  To use live reference standards and working standards for analysis and maintain their records.  To verify the shelf life of the chemical or reagent before performing analysis of the material or product.  To follow the Good Documentation Practices.  To update the Development stability compilation sheet after the review of the ELN.  To investigate if any deviation / abnormal observation in term of results and report to Sub-department Manager.  To check the trend of results before reporting the results.  To keep the status of daily work and report to Sub-department Manager on daily basis.  To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions as an when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.  To keep track of regulatory commitments.  To use standard formats for documentation.  To update the GLP as per Laboratory requirement as per guidance by Sub-department Manager.  To list out all resources required for the study and keep track of routine requirements and ensure timely procurement of the same, verify the materials received for analysis from supplier as per given requirement.  To verify the instruments after the maintenance.  To complete the trainings as per the quality matrix targets.  To prepare and update the SOPs. To prepare method development and verification report. Administrative:  To perform the work as allocated by Sub-department Manager.  To liaise with customers, staff and suppliers.  To write / fill the record in legible writing.  To keep the documentation online with analysis.  To compile required data for Management Information System and provide to Sub-department Manager.  In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities.  To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc. Communication to the management / superiors:  To communicate about any failure or abnormal notification or non-complies results to Subdepartment Manager for their attention and seeking for the solution.  To communicate project related issue to Sub-department Manager and follow the action plan.  To keep status of daily work and report to Sub-department Manager on daily basis. 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.

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. The person will be responsible for the execution and analysis of analytical work (Method development, and development stability sample analysis) performed at Analytical Development Laboratory, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites. To understand the project in the guidance of Sub-department Manager and follow their instructions.  To perform the analysis under the supervision of Sub-department Manager.  To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed.  To operate and calibrate the instruments as per approved standard operating procedure.  To keep track of each activity related to product analysis and development activities.  To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.  To make entry in respective logbook, when start the analysis and at completion of analysis.  To use live reference standards and working standards for analysis and maintain their records.  To verify the shelf life of the chemical or reagent before performing analysis of the material or product.  To follow the Good Documentation Practices.  To update the Development stability compilation sheet after the review of the ELN.  To investigate if any deviation / abnormal observation in term of results and report to Sub-department Manager.  To check the trend of results before reporting the results.  To keep the status of daily work and report to Sub-department Manager on daily basis.  To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions as an when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.  To keep track of regulatory commitments.  To use standard formats for documentation.  To update the GLP as per Laboratory requirement as per guidance by Sub-department Manager.  To list out all resources required for the study and keep track of routine requirements and ensure timely procurement of the same, verify the materials received for analysis from supplier as per given requirement.  To verify the instruments after the maintenance.  To complete the trainings as per the quality matrix targets.  To prepare and update the SOPs. To prepare method development and verification report. Administrative:  To perform the work as allocated by Sub-department Manager.  To liaise with customers, staff and suppliers.  To write / fill the record in legible writing.  To keep the documentation online with analysis.  To compile required data for Management Information System and provide to Sub-department Manager.  In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities.  To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc. Communication to the management / superiors:  To communicate about any failure or abnormal notification or non-complies results to Subdepartment Manager for their attention and seeking for the solution.  To communicate project related issue to Sub-department Manager and follow the action plan.  To keep status of daily work and report to Sub-department Manager on daily basis. 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.

Job Position: PMS Service – Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA.Roles and Responsibilities:To work on Complaint handling Process – Evaluation, Regulatory Assessment, InvestigationWork with lead in completing daily assignation.Organize and manage daily work allocationComplaints remediation using work instruction, compliance to processTo drive efficiency and compliance.Collaborate with of cross function team (CFT) such as Intake, MDR, Investigation to execute the project and initiative.Daily status to lead associateSkills:2 to 4 years of experience in Medical devices complaints handling or any PMS activitiesWorking knowledge of appropriate global medical device regulations, requirements, and standards such as: CFR Parts 803, 806 and 820, ISO 13485, ISO 14971, EU Medical Device Directives/Regulations including MEDDEV GuidelinesFor Complaint Investigation – Mechanical problem analysis skill neededAn excellent communicator, both written and verbal Adopt to cross cultural differencesAbility to work in a timeline driven environmentProficiency using tools such as Trackwise, Sales force, Service Max

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. The person will be responsible for the execution and analysis of analytical work (Method development, and development stability sample analysis) performed at Analytical Development Laboratory, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites. To understand the project in the guidance of Sub-department Manager and follow their instructions.  To perform the analysis under the supervision of Sub-department Manager.  To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed.  To operate and calibrate the instruments as per approved standard operating procedure.  To keep track of each activity related to product analysis and development activities.  To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.  To make entry in respective logbook, when start the analysis and at completion of analysis.  To use live reference standards and working standards for analysis and maintain their records.  To verify the shelf life of the chemical or reagent before performing analysis of the material or product.  To follow the Good Documentation Practices.  To update the Development stability compilation sheet after the review of the ELN.  To investigate if any deviation / abnormal observation in term of results and report to Sub-department Manager.  To check the trend of results before reporting the results.  To keep the status of daily work and report to Sub-department Manager on daily basis.  To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions as an when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.  To keep track of regulatory commitments.  To use standard formats for documentation.  To update the GLP as per Laboratory requirement as per guidance by Sub-department Manager.  To list out all resources required for the study and keep track of routine requirements and ensure timely procurement of the same, verify the materials received for analysis from supplier as per given requirement.  To verify the instruments after the maintenance.  To complete the trainings as per the quality matrix targets.  To prepare and update the SOPs. To prepare method development and verification report. Administrative:  To perform the work as allocated by Sub-department Manager.  To liaise with customers, staff and suppliers.  To write / fill the record in legible writing.  To keep the documentation online with analysis.  To compile required data for Management Information System and provide to Sub-department Manager.  In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities.  To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc. Communication to the management / superiors:  To communicate about any failure or abnormal notification or non-complies results to Subdepartment Manager for their attention and seeking for the solution.  To communicate project related issue to Sub-department Manager and follow the action plan.  To keep status of daily work and report to Sub-department Manager on daily basis. 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.

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. The person will be responsible for the execution and analysis of analytical work (Method development, and development stability sample analysis) performed at Analytical Development Laboratory, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites. Quality:  To understand the project in the guidance of Sub-department Manager and follow their instructions.  To perform the analysis under the supervision of Sub-department Manager.  To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed.  To operate and calibrate the instruments as per approved standard operating procedure.  To keep track of each activity related to product analysis and development activities.  To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.  To make entry in respective logbook, when start the analysis and at completion of analysis.  To use live reference standards and working standards for analysis and maintain their records.  To verify the shelf life of the chemical or reagent before performing analysis of the material or product.  To follow the Good Documentation Practices.  To update the Development stability compilation sheet after the review of the ELN.  To investigate if any deviation / abnormal observation in term of results and report to Sub-department Manager.  To check the trend of results before reporting the results.  To keep the status of daily work and report to Sub-department Manager on daily basis.  To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions as an when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.  To keep track of regulatory commitments.  To use standard formats for documentation.  To update the GLP as per Laboratory requirement as per guidance by Sub-department Manager.  To list out all resources required for the study and keep track of routine requirements and ensure timely procurement of the same, verify the materials received for analysis from supplier as per given requirement.  To verify the instruments after the maintenance.  To complete the trainings as per the quality matrix targets.  To prepare and update the SOPs. To prepare method development and verification report. Administrative:  To perform the work as allocated by Sub-department Manager.  To liaise with customers, staff and suppliers.  To write / fill the record in legible writing.  To keep the documentation online with analysis.  To compile required data for Management Information System and provide to Sub-department Manager.  In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities.  To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc. Communication to the management / superiors:  To communicate about any failure or abnormal notification or non-complies results to Subdepartment Manager for their attention and seeking for the solution.  To communicate project related issue to Sub-department Manager and follow the action plan.  To keep status of daily work and report to Sub-department Manager on daily basis. 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.