Job description Career Category Information Systems Job Description 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. Job Description We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Edit check development and Custom function programing Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of

Job description Career Category Clinical Job Description 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. Manager, CSAR - Global Library What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Ad

Job description Career Category Clinical Job Description 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. Job Description We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Study build and Edit check development Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline with 9+ years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO s, central labs,

Job description Career Category Finance Job Description In this vital role you will be responsible for the Supplier on-boarding process and vendor master data oversight and management. This role includes leading a small team of staff as well as an external Business Process Outsourcing (BPO) provider. The position is critical to drive customer satisfaction across Amgen through optimum utilization of resources, systems and continuous improvements. The Global Supplier On-boarding & Vendor Master Manager will report to the Supplier On-boarding and Requisition to Order Global Operations Senior Manager. This role will be based in India. Manage day to day operations and prioritization of the Supplier On-boarding team to ensure critical issues and escalations are being prioritized appropriately Drive decisions related to Supplier On-boarding and vendor master critical issues Ensure regular oversight and maintenance activities of vendor master data are being conducted on a regular basis Work with the team to continually make updates and improvements to the Supplier On-boarding playbook in accordance with the other Service Owners and Process Owners Monitor performance against service level agreements; ensure service level agreements are met; improve performance against SLAs Monitor the performance of the BPO in relation to supplier on-boarding activities; interact with BPO leadership to make improvements to the service level and support structure Ensure compliance to internal and external policies, regulations and laws applicable to the function Manage special projects related to the Supplier On-boarding process and ensure project milestones are being prioritized appropriately Basic Qualifications: Doctorate degree Or Master s degree and 3 years of Procure to Pay experience Or Bachelor s degree and 5 years of Procure to Pay experience Or Associate s degree and 10 years of Procure to Pay experience Or High school diploma / GED and 12 years of Procure to Pay experience And Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Bachelor s degree in business or any other highly quantitative team 5+ years experience in Procure to Pay processes Demonstrated experience working with different partner groups in a multinational corporation Experience working for a Global corporation Ability to lead global virtual teams in a dynamic environment Strong written, verbal communication and inter-personal skills Intermediate to Advanced level knowledge of office tools e.g. MS Excel/MS Word/MS Office/Smartsheet Be customer focused and have problem solving skills Ability to multi-task and work with short timelines . Role: Operations - Other Industry Type: Miscellaneous Department: Customer Success, Service & Operations Employment Type: Full Time, Permanent Role Category: Operations Education UG: B.B.A/ B.M.S in Management, Any Graduate, Diploma in Mechanical PG: Any Postgraduate Key Skills BPOglobal operationsProcurementInterpersonal skillsService levelExcelMS WordVendorMS Officebusiness process outsourcing

Job description Career Category Finance Job Description 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 Associate Training & Development What you will do Let s do this. Let s change the world. In this vital role you will The Instructional Designer (ID), Global Learning Solutions (GLS) reports to the Sr. Manager Instructional Design Team Lead and supports Global Learning & Performance (GL&P) Learning Professionals across all regions and sites in US, Europe, Intercontinental, and JAPAC. The ID partners closely with commercial learning professionals and marketers to understand performance challenges and desired work outputs. The ID combines their understanding of Amgen s products and commercial staff needs with standard methodologies in Instructional Design while delivering best-in-class performance support, training, and communications solutions for clients. The ID follows creative design standards to ensure all assigned deliverables are met. The ID demonstrates standard methodologies in Instructional Design while delivering best-in-class performance support, training, and communications solutions for clients while following creative design standards to ensure all assigned deliverables are Consults with GLS and/or functional learning partners to ensure the most appropriate learning solutions are proposed Provides instructional design support on learning projects Employs ID standard methodologies in the execution of project deliverables, including design documents, content outlines, workshop materials, performance support tools, and eLearning modules Works - as needed - with vendors, shared service providers, and contract workers to develop and deliver training deliverables Supports the identification and if needed, the creation of media assets Works with learning clients to ensure governance, design, and development processes are followed Maintains functional partnerships with appropriate functional representatives Provides thought leadership on new and innovative ways to Instructional Design Executes on the annual goals of the group and the department Partners with GL&P colleagues to find opportunities for collaboration, process improvement, and resource sharing 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 Training & Development experience OR Bachelor s degree and 3 to 5 years of Training & Development experience OR Diploma and 7 to 9 years of Training & Development experience Minimum of 8+ years as an Instructional Designer or Training & Development professional supporting a multinational organization Experience conducting training needs analysis to identify appropriate learning solutions Experience with eLearning authoring tools and instructional technology (i.e. Articulate Storyline, Rise, Adobe Creative Suite, Vyond, etc.) Experience in clinical trial-related role and / or knowledge of the clinical trial / drug development process Preferred Qualifications: Excellent knowledge of learning theories and instructional design models Consulting and Stakeholder Management Skills Experience developing rapid design solutions Experienc

Job description Career Category Regulatory Job Description Support the development and implementation of transition management and site activation including project schedules and resource allocation. Communicate effectively with stakeholders on transition progress Identify potential risks, develop, and implement mitigation strategies. Collaborate with cross-functional teams to ensure successful execution of transition plans and resolve transition-related issues to ensure smooth transitions. Monitor and track transition activities to ensure they align with scope, schedule, and budget. Tracking changes to transition plans and transition reviews to identify areas for improvement. Assist the transformation senior manager in ensuring effectiveness of US to India work handoff. Technical Skills: Must Have Skills: Minimum bachelors degree and 8+ Years of Directly Relevant Experience Expertise in project management principles and documentation Prior experience in managing U.S. to India corporate knowledge and function transfer. Good to Have Skills: Experience in multi-site project models and client communication Soft Skills: Must Have Skills: Excellent interpersonal and communication skills Strong analytical skills Good time management and organizational skills Excellent managerial skills Problem Solving Collaboration skills Good to Have Skills: Negotiation Skills . Role: IT Project Manager Industry Type: Miscellaneous Department: Project & Program Management Employment Type: Full Time, Permanent Role Category: Technology / IT Education UG: Any Graduate PG: Any Postgraduate Key Skills Analytical skillsTime managementProject managementTransition managementResource allocationCorporateTransitionManagementBudgetingMonitoring

Job description Career Category Quality Job Description India Quality Manager India HOW MIGHT YOU DEFY IMAGINATION Amgen is one of the world s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has also invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an India Quality Manager in India . Live What you will do Reporting to the Senior Manager International Quality JAPAC, the responsibilities of your role will cover, but are not limited to the following: Main Responsibilities Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management: Perform quality oversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers , contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Win What we expect of you Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, val

Job description " The Position Organization : - Jubilant Ingrevia Limited Designation / Position: - Dy Manager QA Band / Grade / Level: - L2 Location : - Bharuch Job Summary (Optional): - Reporting Manager: - Sr. Manager -QA Direct Reports (Optional): - Nil Team Size (Optional): - 10 Matrix Relationship (Optional): - Key Responsibilities Quality professional with 15.0+ years of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement & API Manufacturing, QMS, Qualification, Validation and other Manufacturing functions. Personnel shall have experience to handle certification, customer & regulatory inspection i.e.: IMS, WHO-GMP, FSSC, FAMI-QS, EnMS, Halal, Kosher & Responsible Care & regulatory (FDCA, USFDA, MHRA). Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment & utility system qualification & digitizationDef The Person Qualifications & Experience: - M.Sc- Chemistry 15+ years of exp. Industry experience Personal Characteristics: - Ability to work in a matrix organization. An excellent people manager and leader; able to recruit, develop and retain a high calibre team across diverse departments. Able to work effectively within a global business culture whilst also adaptable to the local cultural environment. Ability to energise his/her team with a clear vision of the business Excellent communication and negotiation skills Should have an entrepreneurial mind-set Strong negotiation and analytical skills ", Role: Quality Assurance - Other Industry Type: Clinical Research / Contract Research Department: Quality Assurance Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education UG: Any Graduate PG: MS/M.Sc(Science) in Chemistry Key Skills Analytical skillsMatrixDeputy Manager QADeputy Manager Quality AssuranceSenior Manager QAGMPCustomer auditsMHRAIMSAPI Manufacturing

Job description Role & responsibilities:- 1. STATUTORY COMPLIANCE: Day to day work & compliance under various acts like Factory Act, Minimum Wages Act, Contract Labor (R&A) Act, EPF Act, Employment Exchange Act, Gratuity and Bonus Act, etc. Ensuring compliance of the provisions in general with particular focus on timely remittances Submission of returns & maintenance of registers/documents etc. with respect to applicable government regulations. Responsible for Legal and Customer Audits. 2. EMPLOYEE WELFARE: Formulation and Administration of various welfare schemes. Arranging for employees uniform, Safety Shoes, Independence Day functions, Republic day Function, Family day function, Kaizen function, etc. Attend accident cases, mediclaim of the employees, and other day to day matters. Resolve HR, Payroll issues, Resolve conflicts, if any among the various interfaces. To develop appropriate systems to capture reasons for employee turnover. People interaction to have the feel of ground realities. Administering half-yearly & annual Medical Cheek-up of employees. Give feedback to Sr. Manager-HR & suggest modifications in the HR process. 3. LIAISONING: Maintaining harmonious relations with the offices of SP, SHO, Food Inspector, Labor Enforcement Officers, Employment Exchange and Apprenticeship Advisors. Liasoning with Electricity Board, U.P. Pollution Control Board, etc. 4. EMPLOYEE RELATION & INDUSTRIAL RELATION: Attend employee grievance, day to day matters of plant in co-ordination with all departmental Heads. Warning Letter, Show cause notice, Disciplinary action, conducting domestic inquiry, periodical Meeting with departmental heads. Periodical meetings with safety committee. Disbursement of wages LTA, medical, preparing full & final settlement, conducting exit interviews, etc. Proper implementations of HR policies. Good knowledge in factory Act and Industrial Dispute act 5. ADMINISTRATION: Employee Facilities like canteen, transportation, uniform. Monitoring of Security system. Safety system management & arrangements. Handling of employee grievances and ensure local level resolution of grievances. Facilitation and arrangements for corporate clients & guests. Domestic administrative purchasing Event management & functions monitoring. 6. EMPLOYEE ENGAGEMENT: Celebrating Individual Birthdays of employees at plant. Celebrate 5S, Kaizen, Suggestion and sports programs coming out with themes for celebrating different Festivals/Occasions. Handling employee queries & grievances. Organizing family visit day. 7. RECRUITMENT: Recruitment through internal & external sources which includes screening of applications, call letters, conducting interviews, arranging pre- employment medical check-up, appointment letter, Manpower Budgeting, Exit interview. Job Postings & making searches through job portals. Responsible for talent search of middle level management, workmen & apprentices. Preliminary screening and salary negotiations with short listed candidates. Even visiting Colleges & Institutes for campus placements. Joining formalities of new joiners and arrange orientation program. 8. LEARNING & DEVELOPMENT: Skill evaluation of employees for up gradation. Preparation of TNI and training Calendar through appraisal process, skill matrix, current competency matrix, training evaluation and entire L&D life cycle. Arranging training programs for all grades of workers & Staff [Internal & External]. Coordinating training programs through Experts.Employee up gradation procedure and implementation matrix. Organize various safety trainings and daily training on floor by supervisors etc. 9. COMPENSATION & BENEFITS: Direct control of time office (i.e. Attendance systems, leave records, c/off records, overtime records, etc). Salary computation & salary processing, annual increment, annual performance appraisal. Annual Bonus & Gratuity computations & payment. 10. CONTRACT MANAGEMENT: Responsible for proper selection of Contractors and their agreements. Ensuring compliances of contractors. Pre-employment checkup & Safety briefing of contrac

Job description In this role, you will: Lead complex data product initiatives, including those that are cross-functional with broad impact, and act as key participant in large-scale planning driving data enablement and capabilities across platforms and utilities Review and analyze complex multi-faceted, larger scale or longer-term data product initiatives that require in-depth evaluation of multiple factors, including intangibles or unprecedented factors to drive data enablement strategies and roadmaps, while adhering to set data governance and standards read more Key Skills Skills highlighted with ‘‘ are preferred keyskills Product Management data product managementdata managementdata analyticsStrategic planning