292 Trackwise Jobs - Page 12

To ensure proper receipt of packing material & misc material after proper verification of documentation, preparation of GRN. To ensure proper verification and segregation of material before preparation of GRN. To ensure material is stored as per locator codes. To ensure proper issuance of packing material from production department. To ensure proper returns of issued packing material from production department. To ensure proper maintenance of documents and records. To prepare MDN's as per SOP as & when required. To ensure day to day records of humidity / tempreture/ performance of weighing scales is being carried out and recorded. To ensure proper handling of rejected material as per SOP. To ensure proper disposal of scrap as and when rquired. To ensure timely release of packing material for production. To generate requirement of packing material and place purchase requisition as per RFC. To follow Trackwise, EDMS for change controls and revision of SOP's as and when required. To maintain the records for calibration, validation of all the equipments installed in warehouse. To reconcile all packing materials as and when required and maintain proper locator codes. Show more Show less

Position Senior Manager Sub-function Global Actions Management Function Corporate Quality Compliance Function Head Title Sr. General Manager Location: Vadodara Areas of Responsibility Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action Ensure assessment of internal learning (such as Quality alert) to derive the global action Preparation of Global action based, following are the sub-activities: v. Review of the regulatory guidance related to the topic vi. Review of existing site practices vii. Drafting of Global action recommendations viii. Preparation of reference procedures and associated formats for Global action implementation as applicable ix. Finalization of Global action recommendation post review with Global action committee and relevant stakeholders Ensure issuance and approving of Global actions in Trackwise. Coordinating with sites for the implementation of Global action recommendations Ensure review of site action closure for completeness and correctness Ensure closure of global action upon completion of all issued site action records of a global action Ensure circulation of Global action status to relevant stakeholders Ensure compliance calls being executed as per pre-defined agenda i.e. internal and external learnings being shared and explained with stakeholders. Ensure identified gaps being shared across sites and tracked for implementation Ensure maintenance of database for regulatory inspections at SUN Pharma Review of draft response of inspection observation Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis All other duties as assigned by Head Corporate Quality Compliance and CQA Travel Estimate Approximate 30% Job Requirements Educational Qualification M.SC / M. Pharm Specific Certification Not specific Skills Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience Minimum 15 years Show more Show less

Job Title Manager Job Grade M2 Function Corporate Quality Compliance Sub-function Complaints Manager’s Job Title Senior Manager-1 Location: Vadodara Job Responsibilities Review of Product Quality Complaint Investigation Reports (US Market). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls & Product Quality Complaint closure. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints Management Travel Estimate Approximately 10% Job Requirements Educational Qualification M.Sc (Life Sciences) / B.Pharm Specific Certification Nil Skills Good Technical & Communication Skills, Investigation writing, reviewing, and editing experience, candidate should have worked in USFDA work environment. Experience 13-14 years Show more Show less

Role & responsibilities 1. Prepare standard documents (SOP, batch records, specs etc) adhering to policies, procedures and regulatory requirements. 2. Responsible for sharing of periodic review reports to stake holders. 3. Responsible for carrying out all the tasks assigned by the reporting manager. 4. Expert in using Track wise digital or any Electronic Documentation Management System. 5. Responsible for carrying out admin role as per the requirement in support to stake holders. 6. Knowledge of quality systems and GMP regulations 7. Excellent verbal, organizational, written, and interpersonal skills required. 8. Sound keyboard skills and knowledge of Microsoft Office applications including Word, Outlook, Excel and PowerPoint. 9. Ability and desire to work in a team-based setting. 10. Ability to work independently and to continuously improve Quality processes. Preferred candidate profile B.Pharmacy, M.Pharmacy , M.S. degree in Chemistry, Microbiology or related field. 1 to 3 years of experience in the pharmaceutical industry (commercial manufacturing sites within API or DP), with experience in Quality Assurance. Experience of Shared Services strongly preferred (dedicated unit for the execution of specific operational tasks for the multiple business units within the organization). Strong knowledge of the pharmaceutical industry regulations applicable to API and Drug Product manufacturers. Good understanding on Good Manufacturing Practices, with practical experience on the field. Expert in using Track wise digital or any Electronic Documentation Management System

Role & responsibilities 1. To ensure GMP compliance on shop floor. 2. To follow SOPS and policies and perform tasks as per the SOP. 3. To perform investigation along with CFT to identify the root cause. 4. To participate in the preparation and review of investigation report for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. 5. To initiate change controls, planned deviations and unplanned deviations related to production department. 6. To provide the awareness training and SOP related trainings to concern personnel. 7. To develop skills in subordinates by motivation and on the job training. 8. To coordinate with internal and external auditor along with CFT. 9. Drafting of investigation for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. To prepare review and timely compliance of audit related observations of production department . Preferred candidate profile B.Pharma / M.Pharma candidate having regulatory exposure of handling QMS systems in pharma industry and sound knowledge technical knowledge as well as good communication skills. candidate must possess 5 to 10 yrs experience in handling QMS process and must have worked in the past in Quality/Manufacturing function.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva Systems is looking for a Migration Practice Manager who will become a leading member of our India Services team, providing migrations solutions for our global project teams implementing Veeva Vault R&D applications and Vault Platform cloud solutions to companies in the life sciences industry. You will lead customer migration implementations by providing expertise with data and document content migrations, Vault API, Vault migration tools, and Vault platform best practices. You will act as a customer advocate, working closely with other Veeva teams (Services, Product, Sales, Strategy) to ensure customer success today and in the future. You will be accountable for migration practice management, services delivery, people, and operational excellence across our R&D customer base and various Vault applications. This is a remote, full-time permanent role with Veeva. What You'll Do Lead migration services for our clients in the US and Europe Manage a diverse team of leaders, architects, project managers, and consultants Be a trusted advisor to customers on migration methodology, approach, and leading practices Build and manage people for their personal and professional development Establish and ensure adherence to methods and tools Create and manage delivery, team management tools, templates, and estimators Help create proposals, and collaborate with account teams, engagement managers, and practice teams during the sales process Work with other practice areas for customer success and develop new offerings Requirements 8+ years of hands-on implementation experience of packaged software and/or cloud applications for life sciences R&D space and/or content management systems (Documentum, Trackwise, Sharepoint, etc.) 3+ years of consulting experience as part of global customer delivery projects Managed technical delivery in a global setting Proficiency with one or more data engineering/management platforms, tools and/or utilities - database/SQL development, Python, AWS etc. Built and managed a team of consultants Experience rolling out new services or products Nice to Have Data and content migration experience Proficiency in one or more pharmaceutical R&D domain areas such as Regulatory, Clinical, Quality, etc. Perks & Benefits Opportunity for rapid progression in a high-growth business Health & wellness programs Flexible vacation policies 1% charitable giving program Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

Job Description Preparation of APQR, review of documents and records. Supporting to Customer complaint & assistance in implementation of CAPA. To assist in maintaining Food safety & Quality management system. To review HACCP verification & validation plan, adhere to FSSAI requirements for the food premixes division and comply with the requirements of various regulatory authorities and customers. To review SOPs, batch manufacturing and packing records, specifications and test methods of the products. Handling of deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety & Quality management system. To assist in compliance to the current ISO 9001, D&C Act, FSS Act 2006, FSSC 22000, FAMI-QS, WHO-GMP, UNICEF and other customer and regulatory requirements. Reporting of daily non-conformance, online deviation if any. Preparation and updation of Q.A departmental SOP’s and loading it in DCS (Document Control System) ENSUR, Change control in trackwise and handling of SAP system. To assist in an audit and compliance process. To provide necessary documents required by CQA and other customers. Co-ordination with marketing Representative in responding customer queries and submitting Questionnaire as per customer requirement. Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111. Ensuring avoidance of breach of data integrity in area. Imparting necessary assistance to shop floor personnel. Adherence to the requirements of EHS norms. Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning University, Quality mindset). Customer / Patient centricity. Document Archival. To assist in effective Hygiene and sanitation program in area. Execution of various initiatives as are suggested by corporate functions. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. Ensure use of PPE To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of waste. Authorized to prevent improper workplace conditions. Authorized for reporting of Hazards, Incident, Accidents and Near miss reporting. Authorized to prepare OH&S performance document. Authorized to conduct training of workmen related to OHSMS. Insuring shade cards and artwork Preparation and review of quality risk assessments Qualifications MSC / B. Tech food Technology About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Show more Show less

Job Description Preparation of APQR, review of documents and records. Supporting to Customer complaint & assistance in implementation of CAPA. To assist in maintaining Food safety & Quality management system. To review HACCP verification & validation plan, adhere to FSSAI requirements for the food premixes division and comply with the requirements of various regulatory authorities and customers. To review SOPs, batch manufacturing and packing records, specifications and test methods of the products. Handling of deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety & Quality management system. To assist in compliance to the current ISO 9001, D&C Act, FSS Act 2006, FSSC 22000, FAMI-QS, WHO-GMP, UNICEF and other customer and regulatory requirements. Reporting of daily non-conformance, online deviation if any. Preparation and updation of Q.A departmental SOP’s and loading it in DCS (Document Control System) ENSUR, Change control in trackwise and handling of SAP system. To assist in an audit and compliance process. To provide necessary documents required by CQA and other customers. Co-ordination with marketing Representative in responding customer queries and submitting Questionnaire as per customer requirement. Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111. Ensuring avoidance of breach of data integrity in area. Imparting necessary assistance to shop floor personnel. Adherence to the requirements of EHS norms. Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning University, Quality mindset). Customer / Patient centricity. Document Archival. To assist in effective Hygiene and sanitation program in area. Execution of various initiatives as are suggested by corporate functions. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. Ensure use of PPE To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of waste. Authorized to prevent improper workplace conditions. Authorized for reporting of Hazards, Incident, Accidents and Near miss reporting. Authorized to prepare OH&S performance document. Authorized to conduct training of workmen related to OHSMS. Insuring shade cards and artwork Preparation and review of quality risk assessments Qualifications MSC / B. Tech food Technology About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 8590 Job Category Quality Assurance Posting Date 05/16/2025, 01:18 PM Degree Level Bachelor's Degree Job Schedule Full time Locations Piramal Enterprises Limited, Plot no. K-1, Mahad, Maharashtra, 402302, IN Show more Show less

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.

Responsibilities : Maintain database on regular basis. Verify data and correct database. Review and verify the entries. Respond to queries for information and access relevant files Comply with data integrity and security policies Roles in Production Planning as well as sales as Back Office candidates Required Skills Must be excellent in written and spoken English; net savvy and adept at computer skills. Good in computer Skill - excel, ppd Logical thinking. Organizing. Good in communication. Required Qualification : - Any Graduation