1749 Gmp Jobs - Page 7

Candidate needs to handle all shop floor responsibilities of plant which includes batch and shift schedules preparation, planning and execution of batches, GMP documentation compliance, support in GMP audit compliance and investigation team

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

Role & responsibilities Company: Cravicious Foods Pvt Ltd Job Title: Packaging In charge / Packaging Supervisor Location: Greater Noida Key Responsibilities: Supervise and coordinate daily packaging operations for frozen chicken products. Ensure adherence to quality standards, safety protocols, and hygiene regulations. Monitor packaging line performance and troubleshoot issues to minimize downtime. Maintain accurate documentation related to packaging processes, batch codes, and quality checks. Lead and train packaging staff to ensure compliance with company standards and procedures. Collaborate with production and quality control teams to ensure timely delivery of packaged products. Implement continuous improvement initiatives to enhance packaging efficiency and safety. Ensure proper handling, storage, and disposal of packaging materials. Conduct regular inspections to maintain cleanliness and sanitation of the packaging area. Preferred candidate profile Bachelor's degree or diploma in Food Technology, Packaging Technology, or a related field. Minimum 2-5 years of experience in packaging, preferably in the food industry or frozen food sector. Knowledge of food safety standards and GMP (Good Manufacturing Practices). Strong leadership and team management skills. Experience with packaging machinery and equipment used in food manufacturing. Familiarity with HACCP, ISO, or other food safety certifications. Attention to detail and quality-oriented mindset.

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

Role & responsibilities Industry Preference: Food, Beverages, FMCG Strong knowledge of GMP, HACCP, and GHP standards Hands-on experience in production operations Expertise in handling non-conforming products and implementing corrective actions Well-versed with quality checking parameters for teabags and pouches Sound understanding of Product Recall & Traceability systems Knowledge of product labeling regulations and compliance Skilled in online quality checks , root cause analysis, and CAPA implementation Proficient in quality documentation , including record-keeping for audits Good exposure to Food Safety standards and practices Proven team handling experience (minimum 3-4 years) in production/quality environments Must Haves: Bachelors degree / Diploma in food technology, Production Engineering, or a related field. Min 3-8 years of experience in QA/QC roles in FMCG/Food/Beverages industry. Knowledge on GMP. Handling of non-conforming product. Quality checking Criteria of teabag / pouch. Good to Haves: Exposure to the tea industry. Familiar with ISO 9001: 2015. Proficiency in tools such as MS Office .

* Implement and manage production processes for injectable DPI and liquid injection product. * Ensure all operations comply with GMP and regulatory requirements. * Prepare daily reports and update process documentation consistently Required Candidate profile * Knowledge of Peptide synthesis, Purification & Lyophilization operation. * Operation of reactor, Nutsche filter, centrifuge * Handling experience of equipment Lyophilizer and Autoclave

As an Executive / Senior Executive in Quality Control (QC), you will play a crucial role in ensuring that products consistently meet the defined quality standards of the company. Your responsibilities will include conducting quality testing of raw materials, in-process, and finished products as per Standard Operating Procedures (SOPs). It will be your duty to identify, document, and escalate any non-conformities or deviations found during testing, while maintaining thorough and accurate records of test results, logs, and batch documents. Your role will also involve ensuring alignment with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements. Collaboration with the production team to troubleshoot and resolve quality-related concerns will be essential. Moreover, you will be preparing and assisting in internal and external audits as well as regulatory inspections. Monitoring key quality metrics and providing inputs for process improvements are also part of your responsibilities. To excel in this role, you should have 2 to 5 years of experience in QC roles within the cosmetics, pharmaceutical, or FMCG industries. A strong technical understanding of quality control protocols, lab equipment, and analytical techniques is necessary. Knowledge of regulatory frameworks such as ISO, WHO-GMP, and FDA will be beneficial. Your detail-oriented mindset, coupled with strong documentation and analytical skills, will be key to success. Proficiency in handling quality management systems (QMS) and MS Office is essential. Effective communication and interpersonal abilities will also be valuable in this position.,

Supplier Quality Data Analyst Duration: Sept 1, 2025 Nov 30, 2025 Location: Remote (Bangalore, India-based) Work Hours: 40 hrs/week, 8 AM – 5 PM EST (flexible) Interview Process: 1 Virtual Round Team: Global Supplier Quality – Operations Pay: 12/hr USD – (41,000 to 42,000/week in India) Role Overview The selected candidate will support the Global Supplier Quality Operations Team with a 50/50 focus on data analytics and quality documentation within a GxP / GMP-compliant environment , using Veeva and Excel-based systems. Responsibilities Maintain and update weekly KPI reports , quarterly performance reports , and supplier quality data sets . Handle supplier qualification documents , including ISO , GxP , and GMP certificates. Monitor expiration dates and request renewals from suppliers. Pull weekly data from supplier quality systems , analyze for errors, and track performance metrics. Manage and track supplier change requests . Upload, monitor, and maintain documents using Veeva software. Conduct data assessments , error tracking , and assist in compliance reporting. Work closely with cross-functional teams during on-the-job training and process ramp-up. Must-Have Skills & Requirements 3+ years experience in documentation or data quality support roles. Strong hands-on experience with MS Excel (reporting, error-checking, formatting). Familiarity with GMP / GxP / ISO compliance environments (Pharma or Medical Device preferred). Working knowledge of Veeva or similar document control systems. Ability to read and understand specifications and track supplier compliance . Comfortable handling data integrity , compliance documentation, and internal reporting tasks. Working 50% Quality Documentation & Compliance 50% Data Analytics & Reporting

Job Summary As a Team Member in the Instrumentation section at Dr. Reddys Laboratories Ltd., your primary responsibility will be to coordinate breakdown activities, improvement activities, and preventive maintenance schedules. You will oversee external contractors, ensuring compliance with safety and quality standards. Your role will involve reviewing production operations, training team members, managing spare parts inventory, and leading troubleshooting efforts to minimize downtime. Additionally, you will be responsible for maintaining budgets, supporting technical activities, and ensuring regulatory compliance to contribute to the efficient and reliable operation of instruments, equipment, and facilities. Roles & Responsibilities - Coordinate with cross-functional team members to ensure improvement activities and preventive maintenance schedules are carried out in SAP. Maintain necessary records and plan preventive maintenance activities according to defined frequencies. - Oversee external contractors and agencies to ensure compliance with safety and quality standards during maintenance operations. - Review production operation instructions such as work instructions (WI) and standard operating procedures (SOPs) to ensure implementation and adherence to quality standards. - Train and assist team members during troubleshooting, breakdowns of machines, and commissioning of new equipment to enhance technical skills and capabilities. - Manage spares inventory for all instrument spare parts, conduct balance investigations, and implement inventory control measures for availability of necessary parts. - Lead troubleshooting efforts for all instrumentation-related breakdowns, identify root causes, and implement corrective actions to minimize downtime. - Plan and consolidate maintenance budgets for the assigned area/unit, ensuring expenses are within budgeted amounts and optimizing cost-effectiveness. - Maintain spares for process equipment by coordinating with OEMs, external vendors, and supply chain management to ensure timely availability. - Ensure timely closure and completion of assigned corrective and preventive actions (CAPAs) to address maintenance issues and improve operational efficiency. - Provide support for technical and documentation activities at the site as directed by the Section Head, ensuring compliance with regulatory requirements. - Prepare, update, and maintain all necessary documents for audits, including SOPs, formats, PM books, protocols, and machine history books, to ensure compliance with GMP and cGMP standards. - Implement Good Engineering Practices at the site to maintain the reliability, safety, and efficiency of instruments, equipment, and facilities. Qualifications Educational Qualification: Diploma or Bachelor's in Engineering Minimum Work Experience: 8-10 years of experience in the pharmaceutical industry with a focus on maintenance and engineering. Skills & Attributes Technical Skills: - Prior experience in maintenance and engineering roles preferred. - Strong understanding of preventive maintenance practices and procedures. - Proficiency in SAP or similar maintenance management systems. - Ability to lead troubleshooting efforts and implement corrective actions effectively. - Knowledge of regulatory requirements, including GMP and cGMP standards. Behavioural Skills: - Attention to detail and strong organizational skills. - Ability to work collaboratively in a cross-functional team environment. - Excellent communication and interpersonal skills. Dr. Reddys Laboratories Ltd., a global pharmaceutical company, is committed to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we operate state-of-the-art manufacturing plants across various locations, delivering quality medicines to patients worldwide. Join us in our mission to accelerate access to affordable and innovative medicines because Good Health Cant Wait. For more information, visit our career website at https://careers.drreddys.com/#!/,

As a Senior Regulatory Affairs Associate at our organization, you will play a crucial role in managing regulatory documentation, resolving technical queries from clients, and supporting vendor qualification processes. With a solid background in the Pharma raw material industry, particularly in excipient products, you will leverage your expertise to ensure compliance with regulatory standards and guidelines. Your responsibilities will include handling all regulatory documents related to excipients, addressing technical queries from pharmaceutical clients, managing technical matters and documentation for excipient manufacturers, and preparing technical documents for the promotion of excipient products. Additionally, you will be expected to provide specific technical documents for manufacturer and product qualification, manage regulatory qualification documents and queries, and coordinate with overseas excipient manufacturers. To excel in this role, you should possess good technical knowledge regarding guidelines, GMP, and testing methods for excipients, along with experience in vendor management. A minimum of 2+ years of experience in a regulatory and data role, as well as team management experience, is required. Candidates with a background in Pharma and experience in team handling will be given preference. This position offers competitive remuneration and benefits, and if you believe you have the necessary skills and experience to succeed in this role, we encourage you to apply. We look forward to connecting with you and potentially welcoming you to our team at CLYZO.,

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

Let s do this. Let s change the world. In this vital role you will be a skilled Software Test engineer to develop, implement and maintain the test scripts for data platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, Database, and Beta. Actively involved in release planning and estimate test efforts Collaborate and test in an Agile development environment Analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow the best QA practices Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. 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: Master s degree and 1 to 3 years of Computer Science, IT or related field experience Or Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience Preferred Qualifications: Must-Have Skills: 3+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 6-8 Years overall experience in Testing & Validation Projects 2 to 4 years overall experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience implementing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and collaboration skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) 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. Ability to balance multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. 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.

We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor s degree in computer science and engineering preferred, other Engineering field is considered 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. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills.

We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor s /Masters degree in computer science and engineering preferred, other Engineering field is considered 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. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills.

Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies. The ideal candidate will have a consistent record of leadership in technology-driven environments using 3DEXPERIENCE Cloud platform and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the customers feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in collaborator and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate standard process sharing, ensuring ongoing alignment with the Technology & Digital strategy Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Business, Engineering, IT or related field . Preferred Qualifications: Functional Skills: Must-Have Skills: Strategize, plan, and implement various phases of PLM roadmap using Dassault Systemes 3DEXPERIENCE platform and integrating with key enterprise platforms Strong Technical/Functional experience solutioning and supporting GMP applications across Engineering, Clinical, Commercial and Quality functions. Demonstrated hands-on experience in managing technology solutions involving one of the leading PLM solutions (Windchill, Teamcenter or 3DEXPERIENCE). Experience integrate PLM with enterprise systems such as Data Fabric, Veeva vault, SAP, MES and SCADA systems. Experience in people management and leading highly skilled matrixed teams, passion for mentorship, culture and fostering the development of talent. Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively manage collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies: Scaled Agile (SAFe) Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Experience with configuring and customizing solutions for Requirements, CAD, Risk, EBOM, MBOM, Configuration/Variants, Recipe, MPP, Document and Change management. Experience leading data migration from various sources to 3DEXPERIENCE platforms. Experience creating solutions using Enterprise Integration Framework and usage of middleware systems such as Mulesoft, Boomi or Tibco. Extensive experience in software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business stakeholders Broad working knowledge of key IS domains and layers Professional Certifications: Scaled Agile Framework (SAFe) for Teams (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. 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. Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams 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.

Let s do this. Let s change the world. In this vital role you willbe serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organisations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Roles & Responsibilities: Working independently, the individual will be responsible for, but not limited to the following: Enter analytical into LIMS Create and update LIMS sample plans Generate Certificate of Analysis Compile batch release documentation Perform QA Approver role on the Quality Events Initiate Quality records for supplier related changes Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Take part in operational and quality improvement initiatives, programs, and projects. Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. This role may require working in shifts or extended hours within the same shift to support global timezones. 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: Master s degree and 1 to 3 years of professional experience in related fields OR Bachelor s degree and 3 to 5 years of professional experience in related fields OR Diploma and 7 to 9 years of professional experience in related fields Understanding GMP/GDP requirements. Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Strong technical writing skills Preferred Qualifications: Experience and strong familiarity with digital tools and computerized systems. Strong continuous improvement attitude and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams 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.

Let s do this. Let s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Lead, mentor and coach junior Quality and Validation engineers in their activities Analyze test results, collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, deviations, change control, non-conformance and other Computer System Validation (CSV) documents. Ensure validation strategies meet regulatory requirements and company standards. Guide junior validation engineers in writing the CSV documents and verify their output for completeness, accuracy and quality. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Lead test automation scripting, framework maintenance, and CI/CD integration. Develop and execute automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Involve actively in release planning and estimate test efforts. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Software Quality and GMP Validation . Must-Have Skills: Experience in Quality Assurance (QA) testing with at least 6 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Strong experience in manual and automated testing for complex applications, especially in the 3DEXPERIENCE platform. Experience in Computerized System Validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). Experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience executing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points Experience with automated and computer-controlled systems validation (21 CFR Part 11) 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. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. 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.

The Sr Associate Supplier Quality position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen multi-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain. Role Description Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Collaborate with raw material suppliers to ensure alignment to quality agreements, identifying performance improvement opportunities Understand and incorporate risk management strategy into the overall raw material lifecycle Provide support to the supplier periodic monitoring oversight activities Support in tactical activities related to internal/external audits and inspections Perform routine quality assessments and provide approval of changes to raw material inspection profiles Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships Work under minimal supervision in line with Amgen Values and Leadership Attributes What we expect of you Education and Experiences: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor s degree in science or engineering and 2+ years of professional experience in related fields Understanding of GMP/GDP requirements Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Deep technical writing skills Preferred Qualifications Strong continuous improvement approach and lean practices experience Understanding of end-to-end supply chain business processes Experience in project management across multiple departments and geographies Quick process understanding, insight and visualizing Strong analytical and problem-solving skills Independent self-starter, able to work autonomously, under pressure and in teams GMP/GDP knowledge and understanding of pharmaceutical regulations Energetic, detail oriented, highly motivated with a can do outlook Change management skills Ability to communicate across all levels of the organization Effective written and verbal communication skills Experience with Microsoft Office Tools including Excel, Word, and PowerPoint Ability to multi-task and prioritize 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.

Let s do this. Let s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. 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.

Let s do this. Let s change the world. In this vital role you will be a skilled Software quality & Validation lead to oversee and handle validation activities for data platforms and custom-built solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. You will play a key validation role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, content management, and integrated data to automate the creation, and management of regulatory content. Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Supervise the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Find opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. 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: Master s degree with 4-6 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree with 6 - 8 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Must-Have Skills: 5+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects 3 to 5 years overall experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience implementing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) 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. Ability to handle multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. 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.

We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen s Global Supply Hubs to Amgen s global markets, and provide QA oversight of QA activities for Global Supply Chain operations. Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, as well as QA triage of Distribution complaints. Work closely with all relevant partners for the end-to-end process and ensure compliance to GMP/GDP. Act as subject matter expert (SME) for transportation related Quality Processes Collaborate with the 3rd Parties to ensure alignment to service levels, identifying and implementing performance improvement Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Understand and incorporate risk management strategy into overall supply chain strategy Provide support for logistic service provider and transportation service provider oversight Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team Provide quality expertise and guidance to operational staff and within multi-functional Amgen teams Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Work under minimal supervision in line with Amgen Values and Leadership Attributes What we expect of you Basic Qualifications and Experience We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor s degree in science or engineering and 2+ years of professional experience in related fields. Understanding of GMP/GDP requirements. Familiarity with logistics processes of parcel, transport, and warehousing providers. Experience in Validation/Qualification of processes, equipment, and facilities. Deep technical writing skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize 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.

In this role you will be serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited to: supplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams Roles & Responsibilities: Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner. Ensure team members are appropriately qualified and trained to perform needed activities per company procedures. Conduct goal setting, performance reviews, and compensation planning to align with organizational goals. Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements. Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation. Develop, monitor and report metrics to senior management to assess the health of the team s performance. Develop solutions that are thorough, practical, and consistent with functional objectives. Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master s degree with 4 to 6 years of experience in quality management systems or a related field OR Bachelor s degree with 6 to 8 years of experience in quality management systems or a related field OR Diploma with 10 to 12 years of experience in quality management systems or a related field. Experience managing staff in a GXP environment Functional Skills: Must-Have Skills: Working foundation in quality assurance roles and proven team leader. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. 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. 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.

Let s do this. Let s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines 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.

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and alignment to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Involve actively in release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Assist with UAT, test data preparation and developing work instructions. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow best QA practices Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Find opportunities for process improvements in validation activities. Know the latest on new technologies, validation trends, and industry standard processes to improve validation efficiencies. Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. 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: Masters degree / Bachelors degree and 5 to 9 years of experience in Software Quality and GMP Validation Preferred Qualifications: Functional Skills: Must-Have Skills: Experience in Quality Assurance (QA) testing with experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). Overall experience in developing, executing and analyzing QA & Test Automation Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Experience with computer system validation and software validation. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable Experience with automated and computer-controlled systems validation (21 CFR Part 11) 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. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. 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.

Let s do this. Let s change the world. In this vital role you will be responsible for leading and charting the course for the Quality Control technology product team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. The ideal candidate will have a proven track record of leadership in technology-driven environments for the Quality Control area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a solid background in end-to-end software development and Quality Control Platforms, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the partners feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Attract and recruit top talent as part of an extensive Technology organization to be hired within India. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute in a professional we seek with these qualifications Basic Qualifications: Master s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills Demonstrated experience in handling technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to handle multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively handle collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. GMP and Validation Experience on Pharmaceutical / Regulated Industry Experience with Managing Quality Control Platforms on a Global Enterprise Environment Have good eye for business. Can demonstrate deep understanding of industry, therapy and product Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Knowledge on Investigational Methodologies and Technical Writing Proficiency Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. 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. Excellent analytical and fix skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams 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.