Baxter Medical Devices

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. Production QMS Outline: Production Documentation Key Responsibilities: . Handling of Production change control activities and cross functional change impact assessment. . Handling of Production document change request and cross functional DCR impact assessment. . Execution of CA/PA records and perform effectiveness check of implemented actions. . Perform risk assessment for Production QMS elements as per impact assessment. . NCR/SNCR, Market complaint and Laboratory investigation and prepare report. . Production documentation related to QMS elements, SOP, Audit compliance. . Regulatory observation compliance. . Work for Audit readiness. . Execution of other project assigned time to time. 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 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 .

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. This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter what 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. Job Summary The Verification Manager SW will be responsible for leading multiple large-scale projects concurrently related to product software and process development and verification, including direct supervision of analysts and indirect leadership of cross-functional team members. What you'll be doing Lead a team of verification engineers, fostering a collaborative, innovative, and performance-oriented environment. Mentor verification engineers to nurture skills development and professional growth. Proficient in collaborating with cross-functional teams and stakeholders across various sites. Demonstrate leadership and execute projects across a highly distributed engineering team. Responsible for mentoring and training the team Manage the engineering resource allocation. Recruit, retain, and develop top engineering talent. Foster an inclusive, collaborative, and high-performance work environment. Manage all phases of verification stages, ensure project timelines are met or exceeded by quality standards. Budgeting : Develop detailed budgets in accordance with project and department plans, and business objectives. Manage budget diligently and be accountable to perform to the budget. Technology transfer : Ensure efficient and effective transition of verification process and methodologies for Software Products Process effectiveness : Ensure appropriate verification processes are followed for effective and timely engagement in project activities. Innovation : Develop and apply innovative approaches to ensure the best outcomes in all aspects of the role. Create an environment in which innovation can flourish through empowerment, encouragement, and support. Associate development : Actively develop and mentor associates. Provide frequent feedback. Be accountable for their success. Continue to raise the bar on the group and help associates rise to expectations. Accountability: Demonstrate strong and clear accountability for the group's performance and delivery Clear communication : Conduct and encourage frequent formal and informal communication within the group to ensure full engagement and efficient operation. Assign, track, and follow-up on various tasks removing obstacles hindering progress What you'll bring Thorough understanding of software verification methodologies and process Proven experience building, maintaining and leveraging strategic and cross-functional relationships through effective communication and collaborative leadership. Prior experience with direct and indirect team leadership. Ability to negotiate and influence cross-functionality and across customer stakeholders. Proven track record of analytical ability, operational excellence and detail orientation. Strong collaboration, stakeholder management and communication skills-including verbal, written, negotiation and overcoming objections. Knowledge of multiple SDLC and STLC methodologies, standards, procedures, and organization that contribute to the development and deployment of technology solutions Thorough understanding of Agile software development methodologies Thorough understanding of Test Automation and SW Reliability methodologies Strong verbal, written and presentation skills for various audiences and leadership levels. Advanced analytical and creative problem-solving skills. Resourceful with ability to use discretion and exercise good judgment Ability to plan, organize and prioritize multiple projects to meet deadlines and complete tasks in an accurate timely manner Logical and efficient, with keen attention to detail. Extremely organized and highly self-motivated and directed. Ability to effectively prioritize and execute tasks while under pressure and enjoys working in a team-oriented, collaborative environment. Education and/or Experience: Bachelors or Master's in computer science, Software Engineering or equivalent required Prior experience managing software verification and integrations projects. Healthcare and/or medical device experience is preferred. 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 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 .

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. Job Role: Sr. Specialist, Global Regulatory Affairs Publishing Job Location: Whitefield, Bangalore Essential Duties and Responsibilities Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions. Responsible for managing regulatory Product Life Cycle activities for electronic Submissions. High Proficiency in managing end-to-end RIMS-Veeva Vault for eCTD/NeeS regulatory submissions. Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal. Perform quality control (QC) checks to ensure high quality submission with zero deficiency. Assist with the update of the publishing processes and SOPs. Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs. Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities. Will have to work independently with minimal support. Proactive tracking of submission status and progress of regulatory filings. Maintenance of Regulatory systems, trackers and databases. Qualifications Bachelor's Degree or equivalent with 5 or more years experience in regulatory electronic document management and/or electronic submission publishing. Must possess strong analytical thinking, and excellent organizational and communication skills. Candidate must be able to work in a team-oriented, fast-paced environment. Strong technical skills (ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases). Demonstrated leadership, coaching or mentoring skills. Excellent verbal and written English communication skills, suitable for multi-location working relationships. Demonstrated teamwork and collaboration skills. 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 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 .

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. Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned. To complete the planned work (Method validation/Submission Studies/Regulatory query) in stipulated time frame given by sub-department manager. To perform all the testing and data recording of API samples, Development Product samples, Validation Samples, Stability samples, Bulk hold samples, RLD samples, PDR samples etc. according to draft/approved Method of analysis or current Pharmacopoeia. To operate the different instruments like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures. To calibrate the Instruments as and when required (Daily/as per schedule) like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures. To use live reference standards, working standards and Impurity Standards for analysis and maintain their records. To verify the shelf life of chemicals and reagents before performing analysis of material or product. To follow good documentation and ALCOA++ practices. To follow the good Laboratory practices in the Department. To follow the instruction and procedure as mentioned in the approved protocol. To keep track of routine requirements. Inform and ensure timely procurements of the same to respective person or Department. To Report and investigate any failure / abnormal observation / deviation / Non-Compliance to sub-department manager and seeking for the solutions. To communicate project related issues to sub-department manager and follow the action plans. 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 prepare standard operating procedures (SOPs) and standard formats for Documentation. To verify the instruments after maintenance of the Instruments. To check preventive maintenance, Breakdown Maintenance and perform risk assessment. To report preventive maintenance and Breakdown Maintenance to sub-department manager. To represent subject matter expertise in the areas of analysis internally and externally as needed. To make Analytical problem-solving efforts to meet urgent business needs. To focus on innovation, process improvement, and/or operational excellence. To execute and manage projects/programs utilize established methods, techniques, or approaches. To Implement new or improved techniques and procedures around specific tasks write and implement SOP's. To complete the training as per the quality matrix targets. To Maintain knowledge of relevant regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities. In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance. 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 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 .

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. Role: Apprentice - Trainee Location: Gurgaon Job description: You will support the team by performing the following tasks, but will not be limited to these only. Draft scripts, narration, and training content under guidance. Support the development of e-learning modules using approved tools (e.g., Articulate Storyline and Rise, Vyond, Camtasia, etc.). Collaborate with team members and subject matter experts to gather inputs and feedback. Create simple assessments and learning activities. Create and integrate multimedia elements (videos, images, graphics) into learning content. Learn and apply instructional design principles during projects. Qualifications and skills required: Basic proficiency in MS Office (Word, PowerPoint, Excel). Interest in e-learning, instructional design, and content development. Good communication and collaboration skills. Eagerness to learn new tools, techniques, and concepts quickly. 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. About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis sterile IV solutions infusion systems and devices parenteral nutrition surgery products and anesthetics and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care 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 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 .

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. Summary: This role is responsible for managing the Product Surveillance team responsible for end to end complaint processing across various products, following the applicable regulations and procedures. This role oversees and is responsible for the team's activities and KPI's. This role demonstrates effectiveness in managing and leading people, decision-making, empowerment of others, problem solving, and task completions for self and others. A strong understanding of FDA, ISO and Baxter Quality systems is also required. Essential Duties and Responsibilities: Serves as a Subject Matter Expert for PostMarket surveillance processes Managing team, including mentoring, coaching, development, performance management and staffing decisions and supervising employees to ensure achievement of operational goals and KPIs, and to ensure team adherence to established processes and regulations Managing daily work assignments for the team for activities related to complaint processing, to ensure on time complaint processing, regulatory reportability determination, and reporting Managing key performance indicators for the team, including creating and/or analyzing operations metrics and reports to identify improvement opportunities Overseeing and providing regular updates and reports on team performance and key metrics to management Participating in resolution of escalated issues. Identifying and escalating issues as appropriate ensuring Postmarket Surveillance leadership is informed of high risk issues in a timely manner Leading and/or participating in cross functional activities and projects, including NCRs/CAPAs Participating and/or leading audit readiness activities and efforts for Postmarket Surveillance function, including potential risk identification, mitigations, and improvements Participating in external and internal Audits as a complaint process Subject Matter Expert, including direct interactions with the Auditor(s), providing support to Audit requests, providing support to responses, and driving completion of Audit commitments, as needed Maintaining a high level of expertise in current regulatory requirements Reviewing, and revising written Procedures and submitting procedural changes as needed May perform other Postmarket Product Surveillance activities as assigned Qualifications: Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization Ability to effectively manage and lead people and encourage teamwork Ability to motivate, develop and influence others Strong understanding of complaint process and regulatory reporting processes, including FDA regulations applicable to Baxter products (medical devices, pharmaceuticals, etc.) Strong critical thinking and problem solving skills Ability to drive decisions and actions quickly and effectively Ability to make independent decisions Understanding of scientific strategies and ability to invent new methods or new avenues of analyzing large data Ability to deal with ambiguity Collaboration and Teamwork Detail Oriented Customer Focus Strong technical writing skills Education and/or Experience: Bachelor's degree (science or engineering preferred) with 5+ years experience in Quality, Manufacturing, Engineering, or a related field. Experience should include 1-2 years of supervisory responsibility, or 7 years relevant experience in Product Surveillance. 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 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 .

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. Technical Support . 2nd Level Technical support to diagnose and troubleshoot onsite or remotely. . Build key relationships within the global technical support, business unit teams & regional SME to address issues, bring best practices and implement timely solutions for customers. . Provide Pre and Post sales technical support . Facilitate Warranty Claim and RMA process & Distributor support for complaint handling with post market surveillance team. . Champion new initiatives including business models evaluation & changes relevant for HST business . Support sales team together with regional service teams for new products and solutions, actively derive service models & pricing for new projects/tenders . Be ambassador for Services, partner with internal (commercial, marketing, product) teams and external teams (distributors/Customers) to drive service excellence and exceptional customer service . Cross train on other BU for backup and supporting customer issues. Provide onsite support as needed for escalations and critical installations. Visit customers & communicate effectively for critical issues and drive solutions . Take additional responsibility for basic technical support for Front Line Care & managing business through distributor/third party service provider Distributors Service Management . Build key relationships with the distributor, cluster leadership and regional technical support teams to leverage our network of expertise across the region to drive service excellence . Ensure product recalls are prioritized and completed in timely & compliant manner, working closely with QA, regional & global teams . Installation support and Installed base management for India, build analytics for parts consumption, contract packages and drive productivity to ensure right parts are ordered. . Responsible for all KPI for Services across India, including response and resolution time . Execute service support plans as per country business priorities . Gather regular feedback from customers & Conduct NPS satisfaction survey with customer/Distributors . Support Spare parts sales strategy and contract to distributors . Partner with distributor & provide onsite support for escalations as required 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 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 .

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 perform the cleanliness of area and machines before starting the filling process. To perform CIP/SIP of machine before commencing the filling activity. To perform availability of Batch filling record before fill the filling activity. To perform the compliance of environmental conditions before commencing the filling activity. To perform the line clearance from IPQA before commencing the filling activity. To run the machine as per approved SOP and in compliance with cGMP To record all the activities in the approved formats at the time of observation/activity is performed. 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 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 .

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. Summary: This role is responsible to supervising the team responsible for handling of complaints across various products, following the applicable regulations and procedures. This role oversees and is responsible for the team's activities and KPI's. This role demonstrates effectiveness in tasks completion, decision-making, empowerment of others, problem solving and team leadership. A functional understanding of FDA, ISO and Baxter Quality systems is also required. Essential Duties and Responsibilities: Serves as a Subject Matter Expert for PostMarket surveillance processes Supervising employees to ensure achievement of operational goals and KPIs, and ensuring team adherence to established processes and regulations Managing daily work assignments for the team and distributing daily assignments to the team, to ensure on time complaint processing, regulatory reportability determination, and reporting Creating and/or analyzing operations metrics and reports to identify improvement opportunities Overseeing and providing regular updates and reports on team performance and key metrics to management Identifying and escalating issues as appropriate ensuring Postmarket Surveillance leadership is informed of high risk issues in a timely manner. Participating in resolution of escalated issues and risks, as assigned Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs Participating in audit readiness activities and efforts for Postmarket Surveillance function Participating in external and internal Audits as a complaint process Subject Matter Expert, including direct interactions with the Auditor(s), providing support to Audit requests, as needed Maintaining a high level of expertise in current regulatory requirements Performing Post Market Surveillance tasks as assigned by line manager Qualifications: Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization Ability to effectively lead a team, motivate and influence Strong understanding of complaint process and regulatory reporting regulations applicable to Baxter products (medical devices, pharmaceuticals, etc.) Strong critical thinking and problem solving skills Ability to drive decisions and actions quickly and effectively Ability to make independent decisions Ability to deal with ambiguity Collaboration and Teamwork Detail Oriented Customer Focus Strong technical writing skills Education and/or Experience: Bachelor's degree (Science or Engineering preferred) 5-8 years of experience in Quality, or related field in the medical products industry Experience with leading people (directly or indirectly through project teams) 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 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 .

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. Your Role at Baxter: Under the supervision of the Senior Manager - Internal Audit, and using a risk-based approach, assist with audit planning, performing and documenting audit testing procedures for IT audits, integrated audits, some SOX testing, management consulting, and other projects, in accordance with the Institute of Internal Auditors (IIA) Global Internal Audit Standards. What you'll be doing: Execute IT, Privacy, Device Security, Operational and Integrated audits throughout Baxter's international and domestic organizations Maintain comprehensive historical audit work paper documentation that fully supports reported audit results, leveraging established department tools and standards. Work collaboratively with others on the Internal Audit team to proactively assess organizational IT risks and ensure effective audit coverage. Identify control gaps and other areas of heightened risk exposure related to governance, risk management, and internal controls within IT processes. Design and deliver achievable meaningful recommendations for management to mitigate the identified risks. What you'll bring: 4-5 years of IT experience with a Bachelor's Degree or 4-5 years of IT experience with an advanced degree Self-starter with strong analytical skills and decision-making capabilities Progressive experience in a Big 4 firm or reputed multi-national company in IT auditing and/or IT Risk & Compliance functions (experience in medical device industry is a plus, but not mandatory) Proven experience executing Information Systems audits and IT General Controls (ITGCs) in the following: Infrastructure Platform (Windows, Unix/Linux, AS400), Cloud Platforms (AWS or Azure or Google), Databases (Oracle/SQL) and large-scale ERP packages (JDE, SAP, Oracle or other similar systems) Knowledge and interest in all things related to data & technology, including the latest trends and developments with a specific focus on areas of technology included: cybersecurity, cloud, data governance, privacy (like GDPR, HIPPA), analytics, enterprise applications (e.g., SAP, Oracle, Workday, Salesforce), disaster recovery, artificial intelligence, systems development methodologies, and SecOps systems (e.g., CrowdStrike, Prisma Cloud, Qualys, Splunk). Progressive internal audit experience at a publicly traded company that includes experience in a risk-based audit environment Ability to multi-task across multiple projects/priorities Experience working audit efforts in a regulated environment especially IT audits Strong understanding of internal controls and business processes across functions, including manufacturing, information systems Sr. Audit Consultants are expected to travel 15-20%, including global travel Qualifications B.Tech. / MBA (IT) / Equivalent degree is must Professional certification (CISA, CISM, CRISC, CIPM, CIPP, CISSP, AWS Practitioner, CIA) are a plus What you may additionally bring: Solid understanding of the quality regulations and auditing techniques required for the medical device industry Ability to create and deliver presentations up to the Executive Committee level Excellent communication skills (oral, business writing, presentations and listening) Strong influencing and negotiation skills High energy and motivation with an ability to quickly adapt to change Front room / back room audit experience Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes or programs including leading sessions as the internal auditor Experience with COBIT and 2013 COSO 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 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 .

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 perform the cleaning and lubrication of machines regularly. To ensure that machines are working smoothly and performing as per standards. To ensure that the packing activities are being performed as defined in the Standard Operating Procedure (SOP) / Batch Packing Record (BPR). To check the status label of packing material prior to take material in packing line. To ensure status labeling to avoid mix-up. To ensure that the packing activities are not started without line clearance. To check & verify the rejection generated during packing are being handled as per SOP and resolve the problem immediately. To ask questions frequently to the workers regarding productivity and quality, to make them updates with GMP. To ensure that after any break down or maintenance, no machine is taken in operation without clearance from QA. To ensure the GMP norms are followed and maintained throughout the packing. To train personnel for the critical operations like visual inspection and labeling. To perform operations like cleaning of packaging equipment, documentation of area, area clearance, line clearance, Status board update. To ensure safety features of all machine is working properly & peoples are using respective personal protective equipment during operation. To follow Standard Operating Procedure (SOP) during entry and exit to plant. To follow the SOP and guide the workers for the same. Administrative: 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 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 .

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. This individual will be part of and provide support to PDO (Product Design/Development Owner) and their team. In this role the individual will be part of the sustaining team that leads the efforts in providing all the necessary design and technical information related to the product, address queries raised by the Cross functional teams and stakeholders (such as RA, QA, Manufacturing, Marketing, etc.). Individual will be able to lead small-medium project. Skills Required To ensure successful initiation, planning and completion of small-medium or complex project through monitoring, tracking, and analyzing project activities and metrics. Serve as Single Point of Contact for team and collaborate with Project stakeholders. Demonstrated experience in Design and Development of medical devices, sustaining activities and related process. Knowledge of applicable FDA, EU regulations and ISO standards including ISO13485, ISO 14971. Demonstrated experience in preparing Design History File and Product Risk Management activities is desirable. Experienced in Design Verification and Validation and writing Test protocols/reports in desirable. Develop design control requirements and Involve in the Design reviews with cross functional team is desirable. Assist the PDO for maintaining the Design History file and related documents. Provide support to cross functional team by Understanding the needs, addressing technical queries/requirements and regulations. Provide Support as required to sustaining engineering projects. Experienced in handling Engineering/Design Change Management process. Extensive knowledge and hands on experience in Good Documentation Practice. Perform tasks with minimal supervision Qualifications: Bachelor's or Master's degree in Mechanical Engineering/ Bio Medical Engineering or Equivalent with 4+ years of experience in Sustaining Engineering projects for Medical Devices. Excellent Verbal and Written skills in English. Excellent communication and presentation skill. Should be able to communicate effectively in a multi-cultural working environment. Strong Collaboration and interpersonal skills. Ability to co-ordinate with stakeholders and Leadership Team. Excellent critical thinking and problem-solving skills and application of methods and tools. Willing to take ownership and take accountability for actions. Maintain timelines for successful completion of activities. Ability to identify and proactively mitigate risks 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 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 .

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. 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 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 .

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 carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To ensure the status label on the material and transfer such material in the respective area. To ensure that all activities followed in accordance with the SOP. To perform the analysis as per the specification & standard test procedure and record the necessary results in respective documents for Raw Material/Packing material/In-process sample, Validation sample, finish products and other samples. To involved and support in investigation of failure of any material or product in case of any out of specification (OOS) or OOT or laboratory incident or non-conformity and take corrective and preventive actions. To prepare reagents and volumetric solution and standardize it. To check and verify standardization and preparation of reagents and volumetric solution. To raise and implement change control or document change request wherever necessary. To perform chemical analysis To assess the results of testing of Raw Material/Packing material/In-process sample, Validation sample, finish products and other sample to ensure alignment with standard operating procedure (SOP) and regulatory guidelines. To perform the calibration of analytical instruments. To follow and ensure Good Laboratory Practices (GLP), Good Documentation Practices and Good Manufacturing Practices (GMP) inside Quality Control. To ensure availability the working & impurities standards as per various pharmacopoeias. To assist Supervisor in preparation of SOP and give suggestions to improve system performance. To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule. To check completion of method transfer successfully in coordination with Analytical Development Lab (ADL) Department. To make entry into LIMS. To ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same. To work for lab readiness for audit and ensure compliance in Laboratory. 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 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 .

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. Essential Duties & Responsibilities: Technical Support Second level technical support to diagnose and troubleshoot onsite or remotely. Build key relationships within the global technical support, business unit teams & regional SME to address issues, bring best practices and implement timely solutions for customers. Provide pre- and post-sales technical support. Facilitate Warranty Claim and RMA process & distributor support for complaint handling with post market surveillance team. Champion new initiatives including business models evaluation & changes relevant for Healthcare Systems & Technologies (HST) business. Support sales team together with regional service teams for new products and solutions, actively derive service models & pricing for new projects/tenders. Be ambassador for services, partner with internal (commercial, marketing, product) teams and external teams (distributors/customers) to drive service excellence and exceptional customer service. Cross train on other BU for backup and supporting customer issues. Provide onsite support as needed for escalations and critical installations. Visit customers & communicate effectively for critical issues and drive solutions. Take additional responsibility for basic technical support for Front Line Care & managing business through distributor/third party service provider. Distributors Service Management Build key relationships with the distributor, cluster leadership and regional technical support teams to leverage our network of expertise across the region to drive service excellence. Ensure product recalls are prioritized and completed in timely & compliant manner, working closely with QA, regional & global teams. Installation support and installed base management for India, build analytics for parts consumption, contract packages and drive productivity to ensure right parts are ordered. Responsible for all KPI for Services across India, including response and resolution time. Execute service support plans as per country business priorities. Gather regular feedback from customers & conduct NPS satisfaction survey with customer/distributors. Support spare parts sales strategy and contract to distributors. Partner with distributor & provide onsite support for escalations as required. Functional Requirements & Competencies: Confident in communicating professionally and effectively with both customers and internal stakeholders with the ability to set and manage expectations. Capability to remain calm and controlled within pressurized circumstances, whilst maintaining the level of urgency. Disciplined, independent in executing tasks, but also a strong team player Highly organized with a very strong attention to detail. Take ownership and be accountable. Understand KPIs and can adapt working practices to ensure service level is maximized Strong customer focus and results oriented. Self-motivated with a high level of initiative. Ability to recognize and escalate potential issues in a timely manner engaging the right counterparts ( locally - regionally - globally both technical / quality / commercial). Qualifications & Experience: This position requires a technical degree or equivalent through experience Minimum 8 years experience as Service Engineer Previous experience working within Technical Service teams in a regional/global environment. Ability to prioritize and communicate effectively both within the Regional / Local Service and the Commercial. Customer facing skills. Ability to manage through people. Ability to identify continuous improvement opportunities. 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 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 .

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 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 .

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. Role: Apprentice, Trainee Location: Gurgaon Job Description: At Baxter, we are committed to delivering remarkable healthcare solutions that make a difference. As an Apprentice, Trainee in our Commercial team, you will be entering a dynamic environment where ambition meets opportunity. This role is based in Gurgaon and offers an outstanding chance to be part of a team that drives impactful changes in healthcare. In this role, your responsibilities will include: Comprehend the business Go-To Market (GTM) strategy along with the product and therapeutic knowledge. Find opportunities and uncover potential for scaling up business for selected products in various customer channels. Identify key accounts where business development activities can be started and carried out with the sales team's assistance. Drive utilization and consumption of key selling products at identified accounts to improve secondary sales and topline. Join our team to improve your skills, work on meaningful projects, and advance in a company dedicated to excellence and innovation! Qualifications & Skills: To thrive in this role, you need to possess the following qualifications and skills: Bachelor's Degree in Science or equivalent experience. Good proficiency in MS Office (Word, PowerPoint, Excel etc.). Good communication and collaboration skills. Strong learning agility with a proactive approach. If you are ready to bring your passion to a company that values your remarkable contributions, we want to hear from you! Join us and help build the future of healthcare with your outstanding skills and determination. 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 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 .

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. This position provides support to the Analytical development laboratory in technical and operational activities such as hands-on support for Physico-chemical analysis, Instrumental analysis , and material characterization or testing for product development. The successful candidate will need to possess solid hands-on technical abilities, excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. The incumbent will perform other duties as assigned. . Define, organize, plan and execute analytical activities and materials characterization of pharmaceutical injectables in compliance with current international/regional/national regulations with the support of senior colleagues and team member s. . Execute experiments towards method development, failure analysis , and root cause analysis in new product development and sustaining product projects within specified timelines, under supervision. . Work with and interpret data of advanced instrumentation techniques, hyphenated techniques , and other analytical techniques. . Execution of work as per standard guidelines like cGLP, GDP, cGMP, Data Integrity, ALCOA, and as per Baxter's defined systems, whenever applicable. . Investigate and provide technical insights for observed adverse physicochemical issues during product devel opment, scale-up, or post-marketing phases. Engage in science-based troubleshooting of the issues. . Provide proposals for product development-related innovations, analytical method innovations, and product/process improvement initiatives in collaboration with senior scientists . Ensure good internal and cross-functional communication and regular status update of activities. . Preparation of scientific product development reports, proposals, and presentations . Work collaboratively with the multi-functional and international project team in activities such as sample preparation for analysis, and operation of analytical instruments as per project requirements. . Provide support as needed in calibration and maintenance of equipment in the laboratory. . Follow Baxter's Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day -to-day activities, to ensure proactive compliance and continuous improvement 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 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 .

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. This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety report processing and /or Quality control for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting. ? Essential Duties and Responsibilities include: Process adverse event reports from a variety of source types (literature or non-literature based on certification) including review and full data entry of adverse event reports determiningseriousness, expectedness, reporter's causality, and overall eventresolution Ensure that the correct suspect drug was selected within the Pharmacovigilance Safety System Write narratives summarizing all relevant medical information for individual case safety reports Code medical terms using standardized medical dictionaries (i.e. MedDRA) Using medical expertise, ensure that all data has been entered and coded correctly in the Global Safety Database Request case investigation to gather all required medical information, including query generation, tracking, andfollow up with reporters in conjunction with local affiliates Perform quality checks both in line and retrospectively as needed May perform case cleanup as required for preparation of aggregate reports May participate in compliance monitoring related activities including CAPA and Quality Control Metrics May perform reconciliation activities with organizations both within Baxter and outside of Baxter Train and mentor new hires Other duties as assigned 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 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 .

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 ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. QA overview for clean room behavior and aseptic activity. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS) To give non-compliance reports to the respective departments in case of internal quality audits and report it to Section Head and Department 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 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 .