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4.0 - 6.0 years
0 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-216059 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Quality Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Validation Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain aligned with industry standards and align with all regulatory requirements. Roles & Responsibilities: Advising clients on how to meet compliance requirements using a risk-based approach. Develop validation documentation and standard operating procedures for various GxP applications. Develop test protocols that thoroughly test business requirements. Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements. Work with client business functions and domain experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required Development of test / validation scripts based on software design and configurations. Develop IQ/OQ scripts as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree OR Master’s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies Proven leadership skills with the ability to multitask and lead multiple validation projects Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology. Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. Expertise with ALM testing and ALM software (HP) Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc) Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance. Good-to-Have Skills: Ability to work independently, excellent problem solving and professional written communications skills. Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus FDA Audit experience a plus & working with regulatory agencies Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Ability to work effectively with global, virtual teams. Excellent analytical and solving skills. Ability to prioritise successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. 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 driven and comprehensive Total Rewards Plans that are aligned with local industry standards. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
1.0 - 3.0 years
6 - 10 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-215811 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the Integrated Case Management Systems on existing & future technologies. In this role, you will wear several hats including requirement gathering, implementation and analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Develop and implement business process improvements to enhance efficiency and effectiveness. Monitor, solve, and resolve issues related to case intake and case processing across multiple systems. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues. Collaborate on the development of test plans and scenarios to ensure robust validation of system updates, patches and new features. Perform regression testing to verify the changes do not negatively impact existing system functionality. 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 Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Functional Skills: Must-Haves Experience in writing user requirements and acceptance criteria in agile project management systems such as JIRA Good communication skills and the ability to communicate with Product Managers and business collaborators to define scope and value for new developments Hands-on experience with the ITIL framework and methodologies like (Scrum). Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Functional Skills: Good to Have Hands on experience in HP ALM, JIRA, Visio, document management systems (e.g. Veeva) and Service Now Experience in management of requirements specifications document, requirements traceability matrix Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Team-oriented, with a focus on achieving team goals. 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. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Posted 2 months ago
4.0 - 6.0 years
6 - 10 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-216054 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist IS Business Systems Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team and will be responsible for driving Life Cycle Management of Empower, Chromeleon, Unicorn and other CDS applications, including GxP validation, testing, and compliance activities, remediation of software vulnerabilities, and managing backup and disaster recovery plans for CDS applications. You will work closely with Lab Scientists, Benchtop Technicians, Product owners, and Business analysts following SAFe® Agile methodologies to drive Platform and Product Innovation beyond the KTLO activities to help accelerate Operational Business Goals and advance Amgen’s mission of serving every patient every time Roles & Responsibilities: Oversee the software, hardware, and firmware development lifecycle for CDS application, ensuring standard methodologies in development, testing, and deployment across the Global Process Development Organization Work within the framework of SAFe® product team, participating in requirements gathering, design discussions, development, implementation, testing, and software validation. Ensure the quality, reliability, and scalability of the CDS applications, following the standard methodologies of software engineering, testing, and documentation. Research and evaluate new technologies and frameworks that can enhance the capabilities and performance of the software solutions. Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Apply machine learning and Gen AI techniques to accelerate operational business process flows associated with CDS applications and leverage CDS data to generate insights and provide recommendations for process improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree OR Master’s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience of owning business applications in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry or knowledge of the pharmaceutical industry GxP system qualification and validation processes for computer related systems Strong knowledge of COTS (Commercial-off-the-shelf) Validations on HPLCs, UPLCs, CEs, GCs, and other standalone systems Proven leadership skills with the ability to lead projects and work closely with a team of hard-working technology professionals Build a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements Solid skills in collaborating and communicating with multi-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Experience with Advancing Capabilities and Delivering Innovative Technology Solutions in a Pharma/Biotech environment Degree in Computer Science, Information Systems, Engineering, or Life Sciences Good-to-Have Skills: At least 5 – 8 years of domain knowledge in health and/or life sciences combined with Information Technology Extensive experience in software development lifecycles Experience using and adoption of Scaled Agile Framework (SAFe) Understanding of ITIL processes and implementation Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Ability to work effectively with global, virtual teams. Excellent analytical and troubleshooting skills. Ability to manage multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. 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. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
1.0 - 3.0 years
5 - 9 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-215814 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting existing & the next generation of integrated case management platform and systems. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, maximizing data analysis to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient adverse event transmissions to critical safety systems. Roles & Responsibilities: Monitor and resolve issues related to data and transmission across multiple systems. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Collaborate on the development of test plans and scenarios to ensure robust validation of system updates, patches and new features Develop automated testing scripts and perform testing to ensure the quality of the product. 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 Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Functional Skills: Must-Haves Experienced in MuleSoft, Java, J2ee & database programming. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Superb communication skills and the ability to communicate with Product Managers and business collaborators to define scope and value for new developments Hands-on experience with the ITIL framework and methodologies like (Scrum). Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Functional Skills: Good to Have Experienced in managing GxP systems and implementing GxP projects. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Familiarity with cloud technologies such as AWS. Ability to explain technical concepts to non-technical clients. Professional Certifications : MuleSoft Certified Developer Level- I or Level- II Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Team-oriented, with a focus on achieving team goals. Ability to manage multiple priorities successfully. Ability to deal with ambiguity and think on their feet. Shift Information: This position may require you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. 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. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Posted 2 months ago
4.0 years
0 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-216052 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist IS Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team working on the lifecycle of the CDS platforms which includes refreshing of all software/hardware within the enterprise CDS platforms. This vital role ensures the CDS platforms remain up to date and ensure all systems remain available for business. Leverage AI and other automation tools to innovate and provide solutions for business. Roles & Responsibilities: Work with the CDS product team to lead the lifecycle of CDS platform software (Empower/Chromeleon/Unicorn) Develop upgrade strategies for the CDS platform lifecycle Work with vendors to determine the optimal path forward for all CDS platforms Provide documentation and strategies to other Amgen teams to support CDS lifecycle activities Provide support and solve for all CDS platforms Develop cost-effective long-term solutions for the CDS platforms across the enterprise Work with various partners in business to determine difficulties Leverage AI & automation to create efficient workflows What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree OR Master’s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience with a minimum of 3 to 5 years in Systems Administration, Cloud technology & Infrastructure Experience with – Networking, DNS, Firewalls, Security, Patching, AWS, VMWare, MSSQL, Oracle, Linux, Windows Server, Databricks, Powershell, Python Proven leadership skills with the ability to multitask and lead simultaneous software/hardware lifecycle projects Create AWS EC2 infrastructure, storage, and other cloud infrastructure Installation and configuration of Oracle, MS SQL, Linux, & other software as needed Ability to understand vendor requirements against business needs Develop and maintain various scripts for server task automation Experience with tools like ChatGPT, Co-Pilot, and other AI tools Experience working in data centers and responding to P1, P2 incidents Experience with ServiceNow, organizational change, ITIL processes & workflows Good-to-Have Skills: Ability to work independently, excellent problem solving and professional written communications skills. Experience with Smartsheets/Excel/Tableau/Spotfire Experience supporting large number & variety of servers 200+ Strong customer focus with ability to work closely with business Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Ability to work effectively with global, virtual teams. Excellent analytical and solve skills. Ability to manage multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. 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. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
1.0 - 3.0 years
4 - 10 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-215894 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Validation Engineer 1 – Vault Quality What you will do We are seeking an experienced Validation Engineer to work on Amgen Veeva Vault Quality and its hosted applications. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also uses domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Find opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict alignment to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, solving, and improving new and existing applications and platforms. Responsibility 6 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 Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Functional Skills: Must-Have Skills: Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Manufacturing Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to work with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Preferred Qualifications: Experience in Veeva Vault Quality and it related business processes Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: Veeva Vault Platform Administrator (preferred) SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
0.0 - 3.0 years
4 - 7 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-216512 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate IS –Safety ART - Signal & Risk Management What you will do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently. Roles & Responsibilities: Supervise daily data processes to identify and resolve issues where files are delayed or stuck. Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions. Work with various internal and external teams to address system dependencies and mitigate bottlenecks. Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability. Collaborate with stakeholders to provide updates and ensure visibility in issue resolution. Develop and refine dashboards or reports to track system performance and file flow metrics. Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement. Responsible for ensuring that data is adhering to the KCI metrics on a regular basis Develop and implement test plans, scripts to validate system updates, patches and new deployments Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them. Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities. Automate repetitive testing processes and improve testing efficiency. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Or Diploma and 4 to 7 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills Strong analytical and problem-solving skills to diagnose and resolve system-related issues. Experience with data transfer processes and tackle stuck or delayed data files. Knowledge of testing methodologies and quality assurance standard processes. Proficiency in working with data analysis and QA tools. Knowledge of Validation of systems Good-to-Have Skills: Experience in Pharmacovigilance systems Experience with Signal or Risk Management platforms is a plus Knowledge or some experience in database programming languages such as Oracle SQL and PL/SQL Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. 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. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
40.0 years
0 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-216592 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The Data Compliance Analyst will be responsible formaintaining data standards, policies,StandardOperating Procedures (SOPs), defined by data owners. These standards, policies, and SOPs will govern sensitive data (e.g., PII) across the enterprise. This data role will also audit security access controls on sensitive data in the different data platforms to ensure Product Teams adhere to the data policies, standards and SOPs. Roles & Responsibilities: Responsible for maintaining data standards, policies, SOPs, by partnering with DataManagement Platforms team, to enable technology to discover, tag, and generate metadata to manage data access controls. Responsible for operationalizing the data access controls and in partnership with functional data owners and technology teams, ensure data access controls, compliance with privacy and security regulations are enforced. Maintain policies and ensures compliance with data privacy, security, and regulatory policies Publish metrics to measure effectiveness and drive adoption of Data Access policies and standards, that will be applied to mitigate identified risks across the data lifecycle (e.g., capture / production, aggregation / processing, sharing, reporting / consumption). Functional Skills: Must-Have Skills: Technical skills with knowledge of Pharma processes and data privacy. General knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. Experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Customer-focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on business process and technology topics Experience of working with or supporting systems used to data governance framework. E.g. Collibra, Alation Excellent problem-solving skills and committed attention to detail in finding solutions Good-to-Have Skills: Experience with Agile software development methodologies (Scrum) Proficiency in data analysis and quality tools (e.g., SQL, Excel, Python, or SAS). Soft Skills: Highly organized and able to work under minimal supervision Analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills Strong attention to detail, quality, time management and customer focus. Basic Qualifications: Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/ Information Systems experience EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request and accommodation.
Posted 2 months ago
40.0 years
3 - 6 Lacs
Hyderābād
On-site
India - Hyderabad JOB ID: R-216590 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: You will play a key role in the implementation and adoption of the data governance framework which will modernize Amgen's data ecosystem, positioning Amgen as a leader in biopharma innovation. This role leverages state-of-the-art technologies, including Generative AI, Machine Learning, and integrated data. This role involves working closely with business stakeholders and data analysts to ensure implementation and adoption of the data governance framework. You will collaborate with the Product Owner and other Business Analysts to ensure operational support and excellence from the team. Roles & Responsibilities: Responsible for the data governance and data management framework implementation for the Development domain of the biopharma lifecycle. Contribute to the operationalization of the Enterprise data governance framework and aligning broader stakeholder community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Contribute to the cross functional alignment in his/her domain(s) of expertise to ensure adherence to Data Governance principles. Maintain documentation on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. for assigned domains. Partner with business teams to identify compliance requirements with data privacy, security, and regulatory policies for the assigned domains Jointly with Technology teams, business functions, and enterprise teams (e.g., MDM, Enterprise Data Fabric, etc.) define the specifications shaping the development and implementation of data foundations. Build strong relationships with key business leaders and partners to ensure their needs are met Functional Skills: Must-Have Functional Skills: Technical skills with knowledge of Pharma processes with specialization in the Development domain of the biopharma lifecycle. General knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. Experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Customer-focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on business process and technology topics Experience of working with or supporting systems used to data governance framework. E.g. Collibra, Alation Excellent problem-solving skills and committed attention to detail in finding solutions Good-to-Have Functional Skills: Experience with Agile software development methodologies (Scrum) Proficiency in data analysis and quality tools (e.g., SQL, Excel, Python, or SAS). Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ambitious to further develop their skills and career Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills High degree of initiative and self-motivation. Good presentation and public speaking skills. Strong attention to detail, quality, time management and customer focus. Basic Qualifications: Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/ Information Systems experience EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
Posted 2 months ago
0.0 years
0 Lacs
Hyderabad, Telangana
On-site
Position: Pharmacist Company Website: https://onehealthassist.com/ Company LinkedIn: https://in.linkedin.com/company/one-health-assist Working time: Monday-Saturday between 10AM-7PM-(Onsite) Location:- Jubilee Hills, Hyderabad About Company - One Health Assist is a Consumer Tech Platform in Health & Wellness. OHA is committed to redefining Health & Wellness by placing individuals at the forefront. Our platform is expertly crafted to meet specific needs, offering a seamless and integrated health & wellness experience that emphasizes personalized care and comprehensive support. Position Summary: We are seeking a Pharmacist to join our growing Health and Wellness company. This role goes beyond traditional dispensing and focuses on empowering clients to lead healthier lives through education, medication management, and integrative wellness support. You will collaborate with other health professionals to deliver personalized care and promote overall well-being. Key Responsibilities: Medication Management: Dispense prescription medications accurately, counsel clients on usage, side effects, and interactions, and ensure compliance with all regulations. Wellness Consultations: Provide guidance on over the counter (OTC) health products, supplements, and lifestyle choices to support holistic wellness. Client Education: Deliver clear, empathetic education on chronic disease management, medication adherence, nutrition, and general health. Collaborative Care: Work with healthcare providers, nutritionists, and wellness coaches to support comprehensive care plans. Health Screenings: Administer or assist with services such as blood pressure checks, immunizations, and health risk assessments (as applicable). Qualifications: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution. Active state pharmacist license in good standing. Strong knowledge of pharmacology, integrative medicine, and OTC products. Passion for preventive care and a holistic approach to health. Excellent communication and interpersonal skills. Experience in retail, clinical, or wellness settings preferred Thanks & Regards Amisha Shelar Contact: 885-057-2613 Email: amisha@onehealthassist.com Job Type: Full-time Benefits: Provident Fund Schedule: Rotational shift Application Question(s): What is your notice period? what is your CTC? Do you have a Telangana state license for the pharmacist? Work Location: In person
Posted 2 months ago
0 years
0 Lacs
Hyderabad, Telangana, India
On-site
About Company - One Health Assist is a Consumer Tech Platform in Health & Wellness. OHA is committed to redefining Health & Wellness by placing individuals at the forefront. Our platform is expertly crafted to meet specific needs, offering a seamless and integrated health & wellness experience that emphasizes personalized care and comprehensive support. Position Summary: We are seeking a Pharmacist to join our growing Health and Wellness company. This role goes beyond traditional dispensing and focuses on empowering clients to lead healthier lives through education, medication management, and integrative wellness support. You will collaborate with other health professionals to deliver personalized care and promote overall well-being. Key Responsibilities: • Medication Management: Dispense prescription medications accurately, counsel clients on usage, side effects, and interactions, and ensure compliance with all regulations. • Wellness Consultations: Provide guidance on over the counter (OTC) health products, supplements, and lifestyle choices to support holistic wellness. • Client Education: Deliver clear, empathetic education on chronic disease management, medication adherence, nutrition, and general health. • Collaborative Care: Work with healthcare providers, nutritionists, and wellness coaches to support comprehensive care plans. • Health Screenings: Administer or assist with services such as blood pressure checks, immunizations, and health risk assessments (as applicable). Qualifications: • Doctor of Pharmacy (Pharm.D.) degree from an accredited institution. • Active state pharmacist license in good standing. • Strong knowledge of pharmacology, integrative medicine, and OTC products. • Passion for preventive care and a holistic approach to health. • Excellent communication and interpersonal skills. • Experience in retail, clinical, or wellness settings preferred Thanks & Regards Amisha Shelar Contact: 885-057-2613 Email: amisha@onehealthassist.com Show more Show less
Posted 2 months ago
0.0 years
0 Lacs
Muvattupuzha, Kerala
On-site
Wanted Faculty for a Pharmacy College, situated at Muvattupuzha, Ernakulam Dist, Kerala Asst Professor in Pharmaceutical Chemistry Assistant Professor in Pharmaceutics Assistant Professor in Pharmacology Job Type: Full-time Pay: ₹25,000.00 - ₹43,565.06 per month Schedule: Day shift Work Location: In person
Posted 2 months ago
0.0 - 2.0 years
1 - 4 Lacs
Hyderabad
Work from Office
ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description The Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently. Roles & Responsibilities Supervise daily data processes to identify and resolve issues where files are delayed or stuck. Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions. Work with various internal and external teams to address system dependencies and mitigate bottlenecks. Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability. Collaborate with stakeholders to provide updates and ensure visibility in issue resolution. Develop and refine dashboards or reports to track system performance and file flow metrics. Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement. Responsible for ensuring that data is adhering to the KCI metrics on a regular basis Develop and implement test plans, scripts to validate system updates, patches and new deployments Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them. Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities. Automate repetitive testing processes and improve testing efficiency. Basic Qualifications and Experience Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Functional Skills: Must-Have Skills Strong analytical and problem-solving skills to diagnose and resolve system-related issues. Knowledge of testing methodologies and quality assurance standard processes. Proficiency in working with data analysis and QA tools. Proficiency in manual and automated testing methodologies Knowledge of writing SQL will be helpful Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP Familiarity with ITIL process Good-to-Have Skills: Knowledge or some experience in database programming languages using SQL Some understanding of API integrations such as MuleSoft Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control and Software Testing Life Cycle (STLC ) Knowledgeable in reporting tools ( e.g. Tableau) Professional Certifications (please mention if the certification is preferred or mandatory for the role) SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegat ing work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information This individual contributor position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation .
Posted 2 months ago
0.0 - 2.0 years
1 - 4 Lacs
Hyderabad
Work from Office
Associate IS What you will do The Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently. Supervise daily data processes to identify and resolve issues where files are delayed or stuck. Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions. Work with various internal and external teams to address system dependencies and mitigate bottlenecks. Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability. Collaborate with partners to provide updates and ensure visibility in issue resolution. Develop and refine dashboards or reports to track system performance and file flow metrics. Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement. Responsible for ensuring that data is adhering to the KCI metrics on a regular basis Develop and implement test plans, scripts to validate system updates, patches and new deployments Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them. Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities. Automate repetitive testing processes and improve testing efficiency. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience (OR) Diploma and 4 to 7 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Must-Have Skills Strong analytical and problem-solving skills to diagnose and resolve system-related issues. Knowledge of testing methodologies and quality assurance standard processes. Proficiency in working with data analysis and QA tools. Proficiency in manual and automated testing methodologies Knowledge of writing SQL will be helpful Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP Familiarity with ITIL process Good-to-Have Skills: Knowledge or some experience in database programming languages using SQL Some understanding of API integrations such as MuleSoft Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control and Software Testing Life Cycle (STLC) Knowledgeable in reporting tools (e.g. Tableau) Professional Certifications SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This individual contributor position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
0.0 - 2.0 years
1 - 4 Lacs
Hyderabad
Work from Office
ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. What you will do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently. Supervise daily data processes to identify and resolve issues where files are delayed or stuck. Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions. Work with various internal and external teams to address system dependencies and mitigate bottlenecks. Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability. Collaborate with stakeholders to provide updates and ensure visibility in issue resolution. Develop and refine dashboards or reports to track system performance and file flow metrics. Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement. Responsible for ensuring that data is adhering to the KCI metrics on a regular basis Develop and implement test plans, scripts to validate system updates, patches and new deployments Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them. Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities. Automate repetitive testing processes and improve testing efficiency. What we expect of you Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Basic Qualifications: Strong analytical and problem-solving skills to diagnose and resolve system-related issues. Knowledge of testing methodologies and quality assurance standard processes. Proficiency in working with data analysis and QA tools. Proficiency in manual and automated testing methodologies Knowledge of writing SQL will be helpful Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP Familiarity with ITIL process Preferred Qualifications: Knowledge or some experience in database programming languages using SQL Some understanding of API integrations such as MuleSoft Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control and Software Testing Life Cycle (STLC) Knowledgeable in reporting tools (e.g. Tableau) EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Posted 2 months ago
1.0 - 3.0 years
3 - 5 Lacs
Hyderabad
Work from Office
Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Owner and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. ? Roles & Responsibilities? ? Collaborate with System Architects and Product owner s to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Owner s and customers to define scope and value for new developments. Collaborate with Engineering , testing teams as well as Product Management to prioritize release scopes and groom the Product backlog. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog. Maintain and ensure the quality of documented user stories/requirements in tools such as Jira . Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Validate that test scenarios meet feature acceptance criteria and customer expectations. Maintain and ensure the quality of documented user stories/requirements in tools like Jira. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. ? Basic Qualifications and Experience? Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience? OR ? Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR ? Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience ? Functional Skills: ? Must-Have Skills: Has experience with writing use r requirements an d acceptance criteria in agile project management systems like JIRA. Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Experience with Agile software development methodologies (Scrum) Experience of DevOps, Continuous Integration and Continuous Delivery methodology ? Good-to-Have Skills: ? Familiarity with GxP , CFR 21 Part 11 and systems validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Experience with testing and validation tools, and testing frameworks Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies ? Professional Certifications (please mention if the certification is preferred or mandatory for the role)? SAFe for Teams certification (preferred) ? Certified Business Analysis Professional (CBAP) (preferred) Soft Skills: ? Able to work under minimal supervision ? Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work ? Excellent analytical and gap/fit assessment skills ? Strong verbal and written communication skills ? Ability to work effectively with global, virtual teams ? High degree of initiative and self-motivation ? Ability to manage multiple priorities successfully ? Team-oriented, with a focus on achieving team goals ? Strong presentation and public speaking skills ? ? Shift Information? This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours .
Posted 2 months ago
1.0 - 5.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Medical Review Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Support MSRT product lead if assigned Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support MSRT Product Lead activities for the list of expected terms in the auto label tool Support Quality Assurance of ICSR medical review (if applicable) Support training to vendor staff (if applicable) on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 3 years of related drug safety experience Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Amgen Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 4 years relevant work 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
1.0 - 3.0 years
3 - 5 Lacs
Hyderabad
Work from Office
Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Owner and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. ? Roles & Responsibilities? ? Collaborate with System Architects and Product owner s to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Owner s and customers to define scope and value for new developments. Collaborate with Engineering , testing teams as well as Product Management to prioritize release scopes and groom the Product backlog. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog. Maintain and ensure the quality of documented user stories/requirements in tools such as Jira . Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Validate that test scenarios meet feature acceptance criteria and customer expectations. Maintain and ensure the quality of documented user stories/requirements in tools like Jira. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. ? Basic Qualifications and Experience? Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience? OR ? Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR ? Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience ? Functional Skills: ? Must-Have Skills Proven ability to collaborate with developers to translate business requirements into technical specifications and demonstrated experience in writing user requirement documents. Experience with Agile software development methodologies (Scrum) Excellent communi cation skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Experience of DevOps, Continuous Integration and Continuous Delivery methodology ? Good-to-Have Skills: ? Familiarity with GxP , CFR 21 Part 11 and systems validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Experience with testing and validation tools, and testing frameworks Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies ? Professional Certifications SAFe for Teams certification (preferred) ? Certified Business Analysis Professional (CBAP) (preferred) ? Soft Skills: ? Able to work under minimal supervision ? Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work ? Excellent analytical and gap/fit assessment skills ? Strong verbal and written communication skills ? Ability to work effectively with global, virtual teams ? High degree of initiative and self-motivation ? Ability to manage multiple priorities successfully ? Team-oriented, with a focus on achieving team goals ? Strong presentation and public speaking skills ? ? Shift Information? This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours .
Posted 2 months ago
3.0 - 7.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Role Description? This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise , validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated . ? Roles & Responsibilities? ? Collaborate with System Architects and Product owner s to manage Validation strategy and Deliverable for the GxP applications. Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault. Execute test scripts to ensure system compliance with regulatory requirements and organizational standards. Identify , document, and track defects during the testing process. Collaborate with development teams to resolve defects and validate fixes. Ensure all testing and validation activities comply with GxP , FDA 21 CFR Part 11, and other regulatory standards. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Offer ongoing support to ensure effective use of the platform. Generate reports and dashboards to monitor testing progress, defect trends, and validation status. Basic Qualifications and Experience? Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience? OR ? Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR ? Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience ? Functional Skills: ? Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 1 1 . Expertise in defining and executing validation strategies aligned with regulatory requirements. Experience in creati ng and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. ? Good-to-Have Skills: ? Proficiency in automation tools, data systems, and validation software (A pplication Lifecycle Management and/ or Veeva Vault Validation Managemen t) Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies ? Professional Certifications (please mention if the certification is preferred or mandatory for the role)? SAFe for Teams certification (preferred) ? Veeva VM certification (preferred) ? Soft Skills: ? Able to work under minimal supervision ? Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work ? Excellent analytical and gap/fit assessment skills ? Strong verbal and written communication skills ? Ability to work effectively with global, virtual teams ? High degree of initiative and self-motivation ? Ability to manage multiple priorities successfully ? Team-oriented, with a focus on achieving team goals ? Strong presentation and public speaking skills ? ? Shift Information? This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours .
Posted 2 months ago
1.0 - 5.0 years
4 - 7 Lacs
Hyderabad
Work from Office
Medical Review Senior Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. Responsibilities: To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
2.0 - 5.0 years
4 - 8 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. In this vital role you will maximises domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams in the Human Resources and Learning & Development area. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality work from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to customers. Develop and implement effective product demonstrations for internal and external stakeholders. Maintain accurate documentation of configurations, processes, and changes. 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 Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in Human Resources and Learning & Development with technology. Experience with Agile software development methodologies (Scrum). Good communication skills and the ability to communicate with senior leadership with confidence and clarity. Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Good-to-Have Skills: Understanding of software systems strategy, governance, and infrastructure. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code, no-code test automation software. Technical thought leadership. Able to communicate technical or complex subject matters in business terms. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology. Experience with Human Resources and Learning & Development (i.e. Workday, Sum Total). Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
2.0 - 3.0 years
0 Lacs
Greater Kolkata Area
On-site
Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R301402 Show more Show less
Posted 2 months ago
2.0 - 3.0 years
0 Lacs
Bihar Sharif, Bihar, India
On-site
Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R301402 Show more Show less
Posted 2 months ago
3.0 - 5.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Role Description: You will play a key role in the implementation and adoption of the data governance framework which will modernize Amgen's data ecosystem, positioning Amgen as a leader in biopharma innovation. This role leverages state-of-the-art technologies, including Generative AI, Machine Learning, and integrated data. This role involves working closely with business stakeholders and data analysts to ensure implementation and adoption of the data governance framework. You will collaborate with the Product Owner and other Business Analysts to ensure operational support and excellence from the team. Roles & Responsibilities: Responsible for the data governance and data management framework implementation for the Research domain of the biopharma lifecycle. Contribute to the operationalization of the Enterprise data governance framework and aligning broader stakeholder community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Contribute to the cross functional alignment in his/her domain(s) of expertise to ensure adherence to Data Governance principles. Maintain documentation on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. for assigned domains. Partner with business teams to identify compliance requirements with data privacy, security, and regulatory policies for the assigned domains Jointly with Technology teams, business functions, and enterprise teams (e.g., MDM, Enterprise Data Fabric, etc.) define the specifications shaping the development and implementation of data foundations . Build strong relationships with key business leaders and partners to ensure their needs are met Functional Skills: Must-Have Functional Skills: Technical skills with knowledge of Pharma processes with specialization in the Research domain of the biopharma lifecycle. General knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. Experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Customer-focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on business process and technology topics Experience of working with or supporting systems used to data governance framework. E.g. Collibra, Alation Excellent problem-solving skills and committed attention to detail in finding solutions Good-to-Have Functional Skills: Experience with Agile software development methodologies (Scrum) Proficiency in data analysis and quality tools (e.g., SQL, Excel, Python, or SAS) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ambitious to further develop their skills and career Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills High degree of initiative and self-motivation. Good presentation and public speaking skills. Strong attention to detail, quality, time management and customer focus. Basic Qualifications: Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/ Information Systems experience Show more Show less
Posted 2 months ago
3.0 - 5.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Role Description: You will play a key role in the implementation and adoption of the data governance framework which will modernize Amgen's data ecosystem, positioning Amgen as a leader in biopharma innovation. This role leverages state-of-the-art technologies, including Generative AI, Machine Learning, and integrated data. This role involves working closely with business stakeholders and data analysts to ensure implementation and adoption of the data governance framework. You will collaborate with the Product Owner and other Business Analysts to ensure operational support and excellence from the team. Roles & Responsibilities: Responsible for the data governance and data management framework implementation for the Supply Chain domain of the biopharma lifecycle. Contribute to the operationalization of the Enterprise data governance framework and aligning broader stakeholder community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Contribute to the cross functional alignment in his/her domain(s) of expertise to ensure adherence to Data Governance principles. Maintain documentation on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. for assigned domains. Partner with business teams to identify compliance requirements with data privacy, security, and regulatory policies for the assigned domains Jointly with Technology teams, business functions, and enterprise teams (e.g., MDM, Enterprise Data Fabric, etc.) define the specifications shaping the development and implementation of data foundations . Build strong relationships with key business leaders and partners to ensure their needs are met Functional Skills: Must-Have Functional Skills: Technical skills with knowledge of Pharma processes with specialization in the Supply Chain domain of the biopharma lifecycle. General knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. Experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Customer-focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on business process and technology topics Experience of working with or supporting systems used to data governance framework. E.g. Collibra, Alation Excellent problem-solving skills and committed attention to detail in finding solutions Good-to-Have Functional Skills: Experience with Agile software development methodologies (Scrum) Proficiency in data analysis and quality tools (e.g., SQL, Excel, Python, or SAS). Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ambitious to further develop their skills and career Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills High degree of initiative and self-motivation. Good presentation and public speaking skills. Strong attention to detail, quality, time management and customer focus. Basic Qualifications: Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/ Information Systems experience Show more Show less
Posted 2 months ago
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