1682 Gmp Jobs - Page 5

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.

Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will have a proven track record of leadership in technology-driven environments using 3DEXPERIENCE Cloud SaaS 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, develop 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 collaborators feel informed and engaged Lead and manage diverse team within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop 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 handling, 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 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 best practice 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 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: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills: Strategize, plan, and implement various phases of PLM roadmap with a clear focus on eliminating manual workflows, streamlined process, and enabling digital thread 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 ENOVIA, DELMIA, CATIA Report Generator, NETVIBES, EKL, and OTScript in a SaaS environment. Strong hand-on experience with configuring and customizing solutions for Requirements, CAD, EBOM, MBOM, Configuration/Variants, Recipe, MPP, Risk, Document and Change management. Must have led multiple data migration from various sources to 3DEXPERIENCE platforms. Must have experience in creating solutions using Enterprise Integration Framework to integrate with enterprise systems such as Enterprise Data Fabric, Veeva vault, SAP, MES systems. Must be familiar with middleware systems such as Mulesoft, Boomi or Tibco. 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 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 using Scaled Agile (SAFe). Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization 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.

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you 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 Contribute actively to 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), Validation Reports, deviations, change control, and non-conformance management. Assist with UAT, test data preparation and developing work instructions. 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, product owners, business owners to execute validation activities and meet project deadlines. Work closely with manager to ensure timely and effective completion of all validation activities in line with project objectives and schedules. Stay current on new technologies, validation trends, and industry best practices 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: Bachelor s degree and 2 to 6 years experience in Software Quality and GMP Validation Preferred Qualifications: Functional Skills: Must-Have Skills: Experience in Quality Assurance (QA) testing with at least 3 years of 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.

We are seeking a highly motivated and experienced Product Owner/Business Analyst/Subject Matter Expert to lead the development and enhancement of our Laboratory Information Management System (LIMS). This role will be responsible for defining and prioritizing product requirements, translating business needs into technical specifications, and ensuring the LIMS effectively supports our laboratory operations. The ideal candidate will possess a deep understanding of laboratory workflows, data management principles, and regulatory requirements within the [Specific Industry - e.g., Pharmaceutical, Biotech, Environmental Testing] industry. This is a hybrid role requiring a combination of product ownership, business analysis, and subject matter expertise. **Responsibilities:** * Define and maintain the product vision, strategy, and roadmap for the LIMS. * Prioritize and manage the product backlog, ensuring alignment with business goals and user needs. * Act as the primary point of contact for the LIMS product, representing the voice of the customer and stakeholders. * Collaborate with development teams to ensure successful product delivery. * Participate in sprint planning, daily stand-ups, sprint reviews, and retrospectives. * Translate business requirements into clear and concise user stories, acceptance criteria, and functional specifications. * Create process flows, use case diagrams, and other visual aids to communicate requirements effectively. * Conduct gap analysis to identify discrepancies between current and desired LIMS functionality. * Assist with user acceptance testing (UAT) and provide support to end-users * Serve as a subject matter expert on LIMS functionality, data management, and industry best practices. * Provide guidance and support to users on LIMS workflows and data entry procedures. * Stay up-to-date on industry trends and emerging technologies related to LIMS. * Participate in the evaluation and selection of new LIMS modules or enhancements. * Ensure the LIMS complies with relevant regulatory requirements, such as [e.g., FDA 21 CFR Part 11, GLP, GMP]. * Develop and deliver training materials and documentation for LIMS users. * Configure and customize the LIMS system to meet specific laboratory needs. 1. The Software Engineering Leader oversees and guides teams to deliver high-quality software solutions aligned with organizational goals and industry best practices.2. Is a professional in technology, proficient in strategic planning, decision-making, and mentoring, with an extensive background in software development and leadership.3. Is typically responsible for setting the strategic direction of software development efforts, managing project portfolios, and ensuring effective execution of software engineering initiatives to meet organizational objectives.4. Builds skills and expertise in leadership, staying abreast of industry trends, and cultivating a collaborative and high-performance culture within the software engineering team.5. Collaborates and acts as a team player with cross-functional teams, executives, and stakeholders, fostering a positive and productive environment for successful software development initiatives. Job Description - Grade Specific Skills (competencies) Verbal Communication

Summary As a key resource within the Audit Management Office (AMO), this role ensures effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e. g. , GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA and Swissmedic. The associate acts as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, the role involves monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. About the Role MAJOR ACCOUNTABILITIES Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e. g. , GMP, GCP), quality, and regulatory-related audits, along with stakeholder management, remediation tracking, status reporting, and lessons-learned sharing. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders such as application managers, system owners, QA, Information Security & Compliance (ISC), and SOP process owners for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA and Swissmedic expectations. Track and proactively manage audit requests across different time zones, ensuring SMEs respond on time, identifying backups where needed, and escalating delays or deviations as appropriate. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Conduct training sessions on audit readiness, including proper inspection etiquette and effective collaboration during audits and inspections. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Escalate compliance deviations and critical quality issues to senior management and coordinate resolution efforts, ensuring corrective and preventive actions (CAPAs) are implemented effectively. Manage relationships at a global level across divisions and functions, including ISC, e-Compliance, and DDIT teams, facilitating cross-functional alignment and collaboration on audit-related matters. Coordinate and participate in audit closing meetings, preparing summaries of findings, tracking observations, and supporting SMEs in addressing them. Partner with security, compliance, and quality experts to identify focus areas, evaluate industry trends, and recommend strategies to improve audit processes and outcomes. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. Drive and coordinate key Sarbanes-Oxley (SOX) activities in collaboration with application teams and external auditors, ensuring alignment to SOX IT controls and timely delivery of evidence while minimizing audit-related disruptions. Ensure adherence to security and compliance policies and procedures within the audit management governance framework, while aligning with internal and external quality standards. Minimum Requirements University degree or equivalent. Master s degree in IT, Quality Management, Business Administration, or related fields. Overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements. In-depth understanding of pharma business processes and their interrelationship with IT systems and regulatory frameworks. Proven track record of managing audits, regulatory inspections, and remediation efforts in pharma or other highly regulated environments. Experince with Computer System Validation (CSV), system testing, and adherence to lifecycle validation processes (e. g. , requirements gathering, system design, validation testing, implementation, and maintenance). Knowledge of ITIL processes and best practices. Demonstrated ability to work effectively in large, cross-functional, global organizations. Proficient in Excel, PowerPoint, and other productivity tools for reporting and presentation. Business-proficient in English (written and spoken). Strong communication skills with the ability to articulate expectations and audit requirements clearly to diverse teams and stakeholders. Ability to manage multiple priorities and time-sensitive processes efficiently. ITIL-certified professional. Strong knowledge of validation practices, including GxP, Sarbanes-Oxley (SOX), and pharmaceutical quality compliance standards. understanding of CSV lifecycle processes, including risk assessment, traceability matrix development, protocol execution, and impact analysis. Business knowledge or experience in IT s role supporting audit and compliance functions within regulated industries. Expertise in Computer System Validation (CSV) testing methodologies and frameworks. ? Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www. novartis. com / about / strategy / people-and-culture Commitment to Diversity and Inclusion: Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary The Global Change Control Manager oversees the entire process of managing GxP-impacting changes within the global manufacturing network. This role is responsible for the change control process from initiation, through impact assessment, planning, execution tracking, documentation, CAPA effectiveness, continuous improvement in change governance, and metrics reporting. The manager works closely with cross-functional teams such as Regulatory, Quality, Operations, to support timely implementation, risk management, and ongoing improvement in change governance. The role also contributes to audits, inspections as well. About the Role Key Responsibilities: Good Understanding of Global Change control process and able to advice on Global and Local Change request strategy. Align between sites and Regulatory team regarding Change control plan, impact / implementation on sites. Prepare the change request plans and present them for endorsement at the Change review board (CRB) Open global change requests, assign impact assessment actions, and manage the lifecycle of Change Requests (CR). Track and report the implementation status of change requests with cross-functional teams. Manage and maintain change control documentation, including updates, version control, and compliance with cGMP and regulatory standards. Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation. Provide support during audits and inspections by ensuring accurate and readily available change control documentation. Collaborate with cross-functional teams (Quality, Operations, Engineering) for accurate documentation. Track and report metrics related to documentation timeliness, compliance, and quality. Comply with internal processes like KPI reporting, ticket management, and functional requirements. Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows. Support and contribute to quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management. Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable. Good Understanding of Process/Cleaning Validation and Technology transfer concepts and requirements including transfer protocols, validation protocols & reporting and comparability reports Collaborate with site teams for Transport Validation / Shipping verification activities including validation risk assessment, testing protocols and reports. Act as SPOC to drive key Global projects within the platform and collaborate with sites to ensure timely execution of tasks/ deliverables Desirable Requirements: Bachelors/Master degree in Pharmacy, Pharmaceutical Technology, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Good understanding of Radio Ligand Therapies (RLT) platform Minimum 10 years of experience in MS&T, Quality Assurance in Manufacturing of Biologics Drug substance and Drug Product. Hands on experience in 1-QEM tool. Strong understanding of Global change control processes, cGMP, and regulatory requirements Proven project management experience in a cross-functional environment (e. g. multi-site, technical development, other functions). PMP is added advantage. Expertise in document management system and writing technical reports Experience in Health authority audits and Self inspections. Good communication, presentation and Interpersonal skills. Proficiency in English (oral and written) is mandatory. Essential Requirements: Quality / Accuracy / Right First Time Quality System Management (Change Control, CAPA, Risk Assessment and EC) Support Accuracy and compliance of change control documentation Timeliness of documentation updates and approvals Stakeholder satisfaction with documentation quality and usability Adherence to regulatory requirements during audits and inspections Effectiveness of standardized documentation processes Skills: Change Control Process Effective communicator Strong cross functional collaboration Biologics Manufacturing Process Project Management Good Documentation Practice Effective stakeholder engagement Report writing Knowledge Of GMP (Good Manufacturing Practices) Deviation management Corrective and preventive action (CAPA) General HSE Knowledge Manufacturing (Production) Manufacturing Technologies. Process And Cleaning Validation Why Novartis: Commitment to Diversity and Inclusion: . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Responsibilities: Manage CSV projects from start to finish. Ensure compliance with GAMP, GDP, CapA, GXP, IT Compliance & LIMS standards. Collaborate with cross-functional teams on system validation. Free meal Cafeteria Food allowance Shift allowance Over time allowance Travel allowance Sales incentives Annual bonus Performance bonus Marriage & childbirth gifts

A Production Pharmacist oversees the manufacturing process of pharmaceuticals, ensuring quality, safety, and compliance with regulations. They manage the production line, monitor processes, conduct quality control, and ensure adherence to Good Manufacturing Practices (GMP). This role also involves planning and coordinating production activities, troubleshooting issues, and potentially developing new products or processes. Here's a more detailed breakdown: Key Responsibilities: Supervision and Management: Overseeing the entire production process, from raw materials to finished products, ensuring adherence to quality standards and production targets. Quality Control: Implementing and maintaining quality control procedures, conducting regular inspections, testing, and validation of equipment, processes, and products. Compliance: Ensuring compliance with all relevant pharmaceutical regulations, including GMP, and maintaining accurate production records and documentation. Production Planning: Developing and optimizing production plans, scheduling activities to meet deadlines and targets. Troubleshooting and Problem-Solving: Identifying and resolving any issues that arise during the production process. Collaboration: Working closely with other teams, such as quality assurance, quality control, and production staff, to ensure smooth and efficient production. Training and Supervision: Training and supervising production staff, ensuring they understand and follow procedures and safety guidelines.

Preparing, Reviewing and Submitting Product Dossiers as per Country Specific guidelines Preparing, Reviewing and Submitting Renewal Dossiers / Variations. Responding to queries raised by Regulatory authority of respective country. Preparing CAPA reports for the audit or market complaints. Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc. Coordinating & Arranging for the registration samples as per country guideline. Reviewing & Approving the Artworks (Text Content) Coordinating with FDCA Person for COPP & GMP and its legalization process. Updating all registration status records. Maintaining Retain Samples Records. Coordinating with customer for filing of dossier & getting it timely approval. SKILLS: Fluent in English. Good communication skills. Ability to work under pressure and to meet deadlines.

Should be capable of handling wet analysis like LOD, Ash content, Moisture content analysis etc Should have the knowledge of instrumentation analysis like HPLC , GC , IR , UV , Titrator etc,, Should have knowledge of GLP , GDP and GMP

Should be capable of handling instrument like HPLC, GC , UV, IR and potentiometry Should have the GMP knowledge and compliance requirement of QC Should have the knowledge on Good laboratory practices .

ROLES & RESPONSIBILITY Oversee the daily operations of the raw material store, ensuring proper storage, labeling, and handling practices are followed. Maintain accurate inventory records of all raw materials, including batch numbers, expiry dates, and storage conditions. Supervise the receipt of incoming raw materials, ensuring quality checks, GRN generation, and documentation are completed. Ensure materials are stored as per predefined environmental and safety standards (e.g., temperature, humidity, segregation). Coordinate with the Quality Control (QC) and Quality Assurance (QA) departments for material clearance and release for production. Implement FIFO/FEFO principles and monitor stock movement to prevent material expiry or obsolescence. Conduct regular cycle counts and support full physical stock audits. Maintain documentation in compliance with ISO 13485, GMP, and company SOPs. Ensure timely issuance of materials to production based on requisitions and maintain issue records. Train and supervise store personnel, ensuring adherence to company procedures and safety protocols. Coordinate with procurement and planning teams for material availability and shortage alerts. Manage store cleanliness, pest control activities, and overall hygiene as per QMS requirements. Qualifications and Skills: Bachelor s degree in Science, Pharmacy, Supply Chain, or related field (preferred). 10+ years of experience in inventory/store management in a manufacturing or medical device company. Strong knowledge of material handling, warehousing systems, and ERP software. Familiarity with ISO 13485, GMP, and regulatory requirements related to raw material handling. Excellent organizational, communication, and problem-solving skills. Attention to detail and commitment to documentation accuracy. Key Competencies: Inventory Management Regulatory Compliance Documentation Accuracy ERP and Barcode Systems Team Management Coordination & Communication Quality Awareness Problem Solving

Role & responsibilities Position: Manager/ Sr. Manager Qualification : B.E / B. Tech (pref. Chemical eng) / M.Sc Additional qualifications: MBA or Diploma in Material Management. No: of years: 8 - 10years Industry: Bio pharma/ Pharma / Pharma Area of Experience: Planning & Procurement or RM, PM and R &D items. Procurement of services. Familiarity with Vendor Qualification procedure in GMP environment Familiarity with PPIC Good Negotiation Skills ( As Volume of procurement is high) ERP: Experience in MM module (SAP) Preferred candidate profile

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

Client consultation and coordination on calls and emails Understanding the requirements of the clients and guiding them Sending quotations of Visa requirements and taking follow ups Verification of the documents required for the Visa and resolving the queries of the clients if any Processing the visa applications Coordination with the embassy/consulates Documentation Follow-ups

The ideal candidate will bring in-depth experience in pharma warehouse operations, with a proven track record of managing large-scale warehouse functions efficiently.

Pre-preparation for Customer Key Handover as per SOP. Generate rapport with the customers coming for Key Handover Demonstrate a high degree of warmth while dealing with / talking to the customers Register all customer feedback/concerns and channelize it as per SOP in order to close the loop. Maintain Customer data confidentiality. Any other activity associated with Customer Engagements/ Events - assist in these

JOB/ROLE DESCRIPTION The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Responsibilities At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Compliance with safety policy and procedures: Facilitate and monitor the performance of regular facility walkthroughs and internal quality audits for biologics operations to ensure adherence to the implemented systems and compliance with regulatory requirements including data integrity assessment. Responsibility for establishment and implementation of a robust cleaning, sanitization & sterilization process. Monitoring of equipments which are related to Facility Management and responsible for review of logbooks and reports. Lead and monitor management of garments and general consumables as per BMP5 facility requirements. Review the SOP s, protocols, study reports procedures in BMP5 operations. Lead and monitor timely tracking of Operational and Compliance Metrics for manufacturing Operations and management reporting. Facilitate and monitor the implementation of the approved CAPA for the Biologics Operations in Facility Management section. Facilitate and monitor waste management as per the established procedures and adherence to the Clean Room Behavior by all the personnel working in the clean rooms. Leading the team in effective manner. Leading the commissioning and qualification & requalification of all equipment s which are related to facility management. Support for timely reporting of deviations, appropriate investigations to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Support for appropriate manufacturing investigations for OOS and results and customer complaint to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Support for risk management for biologics operations (Facility Department) which covers the following elements and ensured proposal and implementation of appropriate risk mitigation actions (CAPA). Quality and Compliance Risks Operational Risks Data Integrity Risks Facilitate and monitor timely preparation, review, and approval of GMP Documentation for BMP5 Facility Management related major equipment s. Standard Operating Procedures (EOP, IOP and SOP). Protocols and Reports Any other GMP relevant documentation. Support for control of documents and records within the Manufacturing Operations. Execution of BMP5 facility related activities by adhering to Syngene s safety and GMP practices. Other competencies required for the role Follow the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment and adhere to the highest standards of quality, integrity & compliance for every work activity. Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar. Attend all assigned mandatory trainings related to data integrity, health, and safety measures. Compliance to Current Good Manufacturing Practices and Good Documentation Practices. Adherence to Standard Operating procedures, Operational control Procedures. Participate in & support the trainings on procedures, protocols, and On-the-Job activities. Follow the discipline of reporting structure at times of escalation. Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s). Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls. Safety and DI Responsibilities: Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security. Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety. Understand all necessary safety protocols and always follow the same to ensure safety for all. Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals. Equal Opportunity Employer . Pls visit us at https://syngeneintl.com/ to know more about us and what we do.