2369 Qms Jobs - Page 8

Role & responsibilities Vendor Qualification & Management: Evaluate, qualify, and maintain vendor/supplier compliance with applicable standards and regulatory requirements. Audit Planning & Execution: Plan, prepare, and execute various types of audits including internal, external, regulatory, and third-party audits. Ensure timely closure of audit observations. Quality Management Systems (QMS): Implement, maintain, and improve QMS practices in alignment with cGMP and global standards. Oversee documentation, deviation management, CAPA, and training programs. Regulatory Compliance: Ensure site-wide compliance with global regulatory standards such as cGMP, ICH guidelines, and ISO 9001:2015. Participate in inspections and ensure readiness. Validation Activities: Lead and support Process Validation and Cleaning Validation activities. Ensure protocol and report preparation, execution, and review are as per regulatory expectations. Equipment & Instrument Qualification: Oversee and review qualification of equipment, instruments, and systems in coordination with cross-functional teams. Risk Assessments & Change Control: Conduct risk assessments and manage change control activities with appropriate impact analysis and documentation. Desired Skills: Strong knowledge of API manufacturing QA systems Exposure to global regulatory audits (e.g., USFDA, EU, WHO) Proficient in documentation, investigation writing, and root cause analysis Excellent communication and leadership skills

Lead daily production to meet output, quality & safety goals. Manage schedules, manpower & equipment. Ensure GMP/SOP compliance. Review BMRs. Resolve issues, optimize processes, oversee key ops & ensure QMS, EHS & regulatory compliance.

Skill required: Tech for Operations - Automated Testing Designation: Quality Engineering Arch Manager Qualifications: Any Graduation/Post Graduate Diploma in Management Years of Experience: 13 to 18 years Language - Ability: English(Domestic) - Advanced About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of the Technology for Operations team that acts as a trusted advisor and partner to Accenture Operations. The team provides innovative and secure technologies to help clients build an intelligent operating model, driving exceptional results. We work closely with the sales, offering and delivery teams to identify and build innovative solutions.The Tech For Operations (TFO) team provides innovative and secure technologies to help clients build an intelligent operating model, driving exceptional results. Works closely with the sales, offering and delivery teams to identify and build innovative solutions. Major sub deals include AHO(Application Hosting Operations), ISMT (Infrastructure Management), Intelligent AutomationPlan, design, script and execute automated functional tests that ensure that all functional and business requirements are met by applications or systems. What are we looking for Functional Test PlanningMicrosoft Functional TestingPerformance Testing StrategyQuality Assurance (QA)Ability to work well in a teamWritten and verbal communicationNumerical abilityResults orientation1 CL7 QA Engineers Roles and Responsibilities: In this role you are required to identify and assess complex problems for area of responsibility The person would create solutions in situations in which analysis requires an in-depth evaluation of variable factors Requires adherence to strategic direction set by senior management when establishing near-term goals Interaction of the individual is with senior management at a client and/or within Accenture, involving matters that may require acceptance of an alternate approach Some latitude in decision-making in involved you will act independently to determine methods and procedures on new assignments Decisions individual at this role makes have a major day to day impact on area of responsibility The person manages large - medium sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation,Post Graduate Diploma in Management

Sessions on various Quality/Management System Mentor & coach companies using Omnex methodologies, deployment. Best in class systems, Problem Solving, APQP/PPAP/FMEA/Lean 6sigma. Undertake consulting/training for clients to ensure certification audits

Skill required: Marketing Operations - Quality Management Designation: Creative Production Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designAct of overseeing all activities and tasks needed to maintain a desired level of excellence. This may include the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. What are we looking for Understanding of the Ecommerce domain (Lazada, Shopee, D2C, etc.) is a plus Interacts with the stakeholders in a professional way. Can deal with last minute changes and issues and pressure situations. Requires timely decision making always most problem being resolved via owninitiative and solutions or through reapplication of skills/ideas from others. Liaise and work collaboratively with colleagues to ensure service results anddevelopments are understood2 to 3 years of experience, preferably Fresh Grads Prior experience with Quality Specialist role preferred which included quality checkof creative assets People-oriented, self-motivated, and able to thrive in ambiguity in a matrixenvironment Ability to work independently and within team environment Experience in eCommerce or marketplace platform is a plus Strong computer skills including Microsoft PowerPoint and Excel Ability to work under pressure Understanding of basic design process and principles Roles and Responsibilities: Perform quality check including typography, composition, content, spell check, image quality and consistency on all assets based on brief submitted. Report any deviations from quality standards or non-conformities and assist in implementing corrective and preventive actions. Provide feedback to Graphic Designers prior to delivery of assets to client in a timely manner. Identify potential miss on assets deliverable prior to delivery to client. Constantly audit report data to ensure internal stakeholder following correct processes. Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Required Skills: Strong coping, emotional resilience, and stress-management skillsExcellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Good Communication Skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Commitment to qualityAbility to work well in a teamAgility for quick learningAbility to manage multiple stakeholdersAbility to handle disputes Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: BCom Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Commitment to qualityAdaptable and flexibleAbility to work well in a teamAgility for quick learningAbility to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Spring Boot Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications are aligned with business objectives. You will also engage in problem-solving discussions and contribute to the overall success of the projects by implementing effective solutions. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of application features. Professional & Technical Skills: - Must To Have Skills: Proficiency in Spring Boot.- Strong understanding of RESTful web services and microservices architecture.- Experience with database management systems such as MySQL or PostgreSQL.- Familiarity with front-end technologies like Angular or React.- Knowledge of cloud platforms such as AWS or Azure. Additional Information:- The candidate should have minimum 5 years of experience in Spring Boot.- This position is based in Mumbai.- A 15 years full time education is required. Qualification 15 years full time education

We are looking for a skilled Accounting Specialist to join our team in the Merchandise Payables department. The ideal candidate will have 6-10 years of experience in accounting and finance, with expertise in managing merchandise payables and ensuring timely payments. Roles and Responsibility Manage and process merchandise payables transactions accurately and efficiently. Coordinate with cross-functional teams to resolve payment-related issues and discrepancies. Develop and implement effective accounting procedures to improve financial performance. Analyze financial data to identify trends and areas for improvement in merchandise payables. Ensure compliance with company policies and regulatory requirements. Maintain accurate and up-to-date records of merchandise payables transactions. Job Requirements Bachelor's degree in Accounting or Finance. Minimum 6 years of experience in accounting and finance, preferably in retailing. Strong knowledge of accounting principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment and meet deadlines. Strong communication and interpersonal skills. Experience working with J C Penney Services India Pvt Ltd is preferred.

Assist in maintaining QMS and documentation (SOPs, BMRs, audit reports). Support internal and external audits. Learn GMP compliance and regulatory guidelines. Coordinate with QA and other teams to ensure smooth quality processes.

Support QMS implementation and maintenance. Conduct internal/external audits, including customer & regulatory. Prepare audit docs, handle vendor/customer questionnaires. Coordinate with teams to ensure GMP. Report deviations, OOS, and assist in CAPA.

Implement and maintain QMS per GMP. Conduct audits, vendor qualification, and quality reviews. Approve SOPs, BMRs, BPRs, specs, change controls, APQRs. Investigate OOS, OOT, complaints, oversee CAPA, and ensure compliance across all departments. Required Candidate profile QMS Implementation | cGMP Compliance | Internal & External Audits | SOP/BMR Review | Change Control | CAPA | APQR | Risk Assessment | Vendor Qualification | Regulatory Compliance | Root Cause Analyse

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but dont meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job Summary To support our extraordinary teams who build great products and contribute to our growth, we re looking to add a Junior Engineer- Manufacturing Engineering in Chennai. What a typical day looks like: Knowledge on Electronics components and PCBA Support Engineering team for SMT & TEST Programming activities. Knowledge on process flow & work instructions Knowledge in SMT process & RFQ. Knowledge in Quality Management System. Creative and innovative thought on PCBA Document creations for NPI products. Liaise with Process and manufacturing team to come up with detailed manufacturing Information (When needed). Adhere to process and look for possible process improvements. Knowledge in PLM/ERP Tools. Candidates Must from Electronics Manufacturing / Process Engineering field. The experience we re looking to add to our team: Candidates Must from Electronics Manufacturing / Process Engineering field 0-2 year of experience in PCBA Process / Manufacturing / Assembly Process Experienced in technical document preparation. Knowledge in SMT process Good English Communication skill Should have good Microsoft Excel, Power Point & Word skills. Good analytical skills, logical thinking. Here are a few examples of what you will get for the great work you provide: Paid Time Off Health Insurance DD13 Job Category Production Engineering Required Skills: Optional Skills: Flex pays for all costs associated with the application, interview or offer process, a candidate will not be asked for any payment related to these costs. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex. com and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).

Job Title: Quality Engineer. Experience: 4 to 10 years Location: Mysuru Notice Period: immediate to 15 days Mandatory Skill: QMS, Capa, GMP/Gdp/ GLP, Change Control, Deviation, Sop Preparation JD : Good understanding of Pharmaceutical GMP/GLP/GDP practices. *Experience in Pharma QMS activities like, handling Change Controls, Deviations, vendor qualifications and SOP updates. *Understanding of Internal Audits and CAPA closures. *Supporting for Quality metrics program. *Proficient experience with MS-office is required. *Strong written and verbal communication skills are essential *Experience working with virtual teams • Understanding of ISO 9001:2015 is required. *Strong communication, teamwork, data analysis, inductive reasoning and root cause analysis skills are required.

The candidate will be responsible for developing new VBA applications, including SQL queries, as well as maintaining and updating existing tools when required. They will actively participate in testing activities in collaboration with the TPLC teams (Transformation and BAU) while adhering to AGI’s documentation standards. Additionally, the candidate will provide technical support for VBA macros, ensuring prompt resolution of any issues or malfunctions to restore full functionality Roles and Responsibilities The candidate will be responsible for developing new VBA applications, including SQL queries, as well as maintaining and updating existing tools when required. They will actively participate in testing activities in collaboration with the TPLC teams (Transformation and BAU) while adhering to AGI’s documentation standards. Additionally, the candidate will provide technical support for VBA macros, ensuring prompt resolution of any issues or malfunctions to restore full functionality

Preparing & complying with documents as per QMS/API Q1/EMS/OHS Interaction with certification bodies for audit systems,Training to all concerned in management systems as well as customer specific requirements Customers audits for management systems. Required Candidate profile Candidate should have exeprience in QMS Having experience in Oil/Automotive Industry

We are seeking a skilled QMS Consultant. This role is critical in helping automotive manufacturers and suppliers adhere to IATF 16949, CQI 9/11/12/15/27 , GD&T , ISO 14001,ISO 45001,VDA standards by developing and implementing effective QMS Measures

DME/BE - Mech with at least 10-15 years of experience in automotive industries, Knowledge of IATF 16949,VDA 6.3, Pokayoke, Kaizen. Having ERP Knowledge shall be preferred.

Role Overview Responsible for qualification & calibration of Microbiology instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Microbiology instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to handle biosafety cabinet, LAF, glass bead sterilizer, water bath, Autoclave, refrigerator, Incubator, Balance & pH meter etc. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Microbiology/Biotech with proven experience of min. 2-3 yrs. in Instrument qualification and calibration. Awareness of analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities. Job Location - Mulund

Could you be the full-time Components Sub-System Manager in Coimbatore, Tamil Nadu were looking for? Your future role Take on a new challenge and apply your comprehensive project management expertise in a new cutting-edge field. Youll work alongside innovative, dedicated, and collaborative teammates. You'll contribute to the successful execution of project components, ensuring quality, cost, delivery, and performance objectives are met. Day-to-day, youll work closely with teams across the business (Sub-System team, Project Core Team, Suppliers), lead and coordinate component activities, and much more. Youll specifically take care of cascading and allocating component requirements, but also managing stakeholder engagement and project deliverables. All about you We value your passion and attitude. Thats why we dont expect you to have every single skill. Instead, weve listed some that we think will help you succeed and grow in this role: Education: Bachelors degree in Electrical/Electronics/Mechanical engineering. Minimum 12+ years of Experience handlingend-to-end project management from manufacturing industries with a multinational context. Knowledge of planning, organizing, and delegating project tasks effectively. Familiarity with working in international teams and cross-functional collaboration. A PMP/IPMA certification (preferred). Strong leadership, autonomy, and problem-solving skills. Proactive communication and the ability to motivate teams. Well look to you for: Effective application of project strategy and commitments Proactive contribution to project performance and risk management Ensuring compliance with industry and company standards and regulations Leading and coordinating end-to-end component activities Managing component level decisions and KPIs Representing Alstom to customers and external stakeholders when necessary Things youll enjoy Join us on a life-long transformative journey the rail industry is here to stay, so you can grow and develop new skills and experiences throughout your career. Youll also: Enjoy stability, challenges and a long-term career free from boring daily routines Work with new security standards for rail signalling Collaborate with transverse teams and helpful colleagues Contribute to innovative projects Utilise our agile working environment Steer your career in whatever direction you choose across functions and countries Benefit from our investment in your development, through award-winning learning Progress towards leadership and advanced project management roles Benefit from a fair and dynamic reward package that recognises your performance and potential, plus comprehensive and competitive social coverage (life, medical, pension)

Season's Greetings to you from Harvas! A leading company from Industrial Automation manufacturing Special Purpose Machines is hiring ASSOCIATE / DEPUTY MANAGER / MANAGER - QUALITY CONTROL - SPM JOB LOCATION: Hosur, Tamil Nadu (Bordering Bengaluru Electronic City) Role & responsibilities Meeting the end-to-end QC requirements - incoming , in-process inspection and final inspection of the special purpose machine Incoming inspection of all manufactured and fabricated items In-process inspection of assembly, pallet, fixtures, at various stages of execution. Validation of machines for its qualification deliverables (performance, safety, ergonomics and aesthetics) Drive meeting the customer-specific quality policies/ requirements Drive meeting the quality standards as applicable to the industry Process compliance to applicable QMS (ISO, EMS, OSHAS etc) Leading the supplier assessments and competency enhancement Responsible for quality compliance for SPM and Manufactured items. Groom and drive the teams in meeting the daily deliverables Align business metrics with timely decisions with functional MIS Exposure to methods engineers in a related in SPM industry would be an added advantage. Preferred candidate profile BE/B.Tech Mechatronics/Mechanical/Electrical Diploma in Mechatronics can be considered with outstanding expertise in the given segment 12+ years of experience in QC/QMS in Automation-SPM Sound Manufacturing background Basic knowledge Machining, Surface Treatment and Heat Treatment processes Basic knowledge in electrical and electronics , Machine programming Problem solving tools (7QC, 8D concepts) Working Knowledge on RCA, CAPA and Risk management Exposure to Global Packing Procedures and Compliance Process knowledge complying to QMS Knowledge in Six Sigma, lean Mfg Concepts, Statistical analysis, SPCs, FMEA Please feel free to connect with us @ WhatsApp Number +91-98403 46894 / Mail: RAJENDRAN@HARVAS.NET

Quality Management System (hereinafter QMS) audit is essential for any organization that wants to ensure its products and services meet the highest quality standards. It is a systematic examination of an organization's QMS to identify areas for improvement and ensure adherence to relevant standards and regulations. Quality Manual Procedures Work Instructions Records of previous audits Importance of Document Control

Reporting to the Senior Manager International Quality JAPAC, the responsibilities of your role will cover, but are not limited to the following: Main Responsibilities Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management: Perform quality oversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers , contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Win What we expect of you Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus Thrive What you can expect of us As we work to develop treatments that take care of others, we work to care for our teammates professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Let s do this. Let s change the world. In this vital role you will primarily responsible for close collaboration with stakeholders to gather requirements, prioritize features, and guide the development process. The role represents the needs of customers and the business within Quality Management System domain and ensures that strategy and implementation remain connected throughout the value stream. The ideal candidate has good experience in product management, good communication skills, and a deep understanding of Agile methodologies. Roles & Responsibilities: Collaborate with stakeholders to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered Manage relationships with product / platform /system vendors, ensuring that service levels are met and that the organization derives the best value from its investments Ensure that platforms align with security standards, regulatory requirements, and organizational policies Analyze customer feedback and support data to identify difficulties and opportunities for product improvement Functional Skills: Must-Have Skills Knowledge of Pharma business processes and Global regulations. Experience with Veeva Platforms and/or Products Quality Suite Ability to understand and map business requirements to system capabilities Comfortable engaging with global stakeholders, communicating both technical and non-technical issues Good-to-Have Skills: Understanding of Quality processes within the biopharmaceutical industry. Curiosity of modern technology domain and learning agility Experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business stakeholders Broad working knowledge of key IS domains and layers Professional Certifications Veeva Vault Platform Administrator (preferred) Scaled Agile Framework (SAFe) for Teams Soft Skills: Excellent analytical and problem-solving skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.