95 Gxp Jobs - Page 2

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

We are looking for a strategic and seasoned Manager / Sr. GM - Human Resources to lead and elevate our Human Resources function at Chieron Active Ingredients Pvt Ltd. This critical leadership role will oversee the entire HR department across multiple locations, ensuring the effective implementation of HR policies, fostering a positive and productive company culture, and driving strategic HR initiatives aligned with business objectives. The ideal candidate will possess deep expertise in stakeholder management, industrial relations, contract workforce management, compliance, audit & governance, talent acquisition & development, HR operations & policy governance, and strategic HR leadership. This role demands a proactive leader capable of navigating complex labor environments, fostering strong union relations, and ensuring full labor law compliance. The successful candidate will champion talent development, drive performance management, and spearhead succession planning initiatives to build a high-performing workforce. They will also be responsible for liaising with statutory bodies, ensuring adherence to GXP standards, and leveraging HRIS to optimize HR operations. This is an exceptional opportunity to shape the future of HR within a dynamic pharmaceutical manufacturing environment. Job Details: Industry: Pharmaceutical Industry (API/ Intermediate) Department: Human Resources Role: Sr.GM/ Manager Human Resources (API Pharma Manufacturing) Location: Hyderabad Experience: 10+ years with at least 5 years in a leadership role. Prior experience in the API industry preferred. Employment Type: Full-time Qualifications: A degree in Human Resources or a related field Responsibilities: Strategic HR Leadership & Vision Develop and execute HR strategies aligned with the company's overall business objectives, focusing on growth and sustainability. Provide leadership and guidance to the HR team, fostering a culture of collaboration, innovation, and continuous improvement. Oversee organizational development initiatives to enhance employee engagement, productivity, and overall organizational effectiveness. Lead the development and implementation of HR policies and procedures, ensuring compliance with legal and regulatory requirements. Monitor and analyze key HR metrics to identify trends and opportunities for improvement. Drive succession planning initiatives to ensure a pipeline of future leaders within the organization. Talent Acquisition & Onboarding Lead the talent acquisition process, from sourcing and screening candidates to conducting interviews and extending offers. Develop and implement effective recruitment strategies to attract top talent in the pharmaceutical industry. Oversee the onboarding process, ensuring new hires are properly integrated into the company and equipped for success. Manage relationships with external recruitment agencies and vendors. Analyze recruitment metrics to optimize the talent acquisition process and reduce time-to-hire. Ensure compliance with all applicable employment laws and regulations during the recruitment process. Talent Development & Performance Management Design and implement talent development programs to enhance employee skills and capabilities. Oversee the performance management process, ensuring fair and consistent evaluations. Provide coaching and mentoring to employees to support their professional growth. Identify and address performance issues through performance improvement plans and other interventions. Develop and implement leadership development programs to build a strong leadership pipeline. Evaluate the effectiveness of talent development programs and make adjustments as needed. Industrial Relations & Compliance Manage relationships with labor unions and ensure compliance with collective bargaining agreements. Lead negotiations with labor unions and resolve labor disputes. Ensure compliance with all applicable labor laws and regulations, including the Factories Act. Oversee employee relations matters, including investigations and disciplinary actions. Develop and implement policies and procedures to promote a positive and productive work environment. Liasoning with Statutory Bodies such as Labour department, Factories Inspectorate etc. HR Operations & Policy Governance Oversee the day-to-day operations of the HR department, ensuring efficient and effective service delivery. Manage the HRIS system and ensure data accuracy and integrity. Develop and implement HR policies and procedures, ensuring compliance with legal and regulatory requirements. Manage employee benefits programs, including health insurance, retirement plans, and paid time off. Oversee payroll processing and ensure timely and accurate payments to employees. Ensure compliance with all applicable data privacy laws and regulations. Stakeholder Management & Liaisoning Build and maintain strong relationships with key stakeholders, including senior management, employees, and external partners. Serve as a trusted advisor to senior management on HR-related matters. Collaborate with other departments to ensure alignment of HR initiatives with business objectives. Represent the company at industry events and conferences. Act as a liaison between the company and external regulatory agencies. Manage communication with employees regarding HR policies and programs. General Expectations and Past Experiences: Proven experience (10+ years) in Human Resources Management, with at least 5 years in a leadership role, and significant experience in the pharmaceutical (API) manufacturing industry. Demonstrated expertise in Industrial Relations, including union negotiations and labor law compliance, particularly with the Factories Act. Strong track record in developing and implementing effective Talent Acquisition and Talent Development programs. In-depth knowledge of GXP and other relevant regulatory requirements for pharmaceutical manufacturing. Exceptional leadership and interpersonal skills, with the ability to influence and negotiate effectively at all levels. Proficiency in HRIS systems and other HR technology solutions. Experience in managing HR functions across multiple locations.

Summary Are you a seasoned Automation Engineer with a passion for cutting-edge technology and a desire to revolutionize manufacturing processesIf so, we invite you to join us as an Associate Director ITOT Automation Engineer at Novartis, As an integral member of our team, you will play a critical role in defining and implementing the automation concept for both our new and existing manufacturing facilities Your expertise will be instrumental in ensuring that our automation designs and equipment are aligned with IT/OT standards, while leveraging the latest technologies available, In this pivotal position, you will be involved in a wide range of investments, collaborating with cross-functional teams to achieve the maximum level of automation on our shop floors By harnessing the power of global IT/OT technologies, you will help us reach new heights of productivity and efficiency, With your technical proficiency and visionary mindset, you will lead the charge in transforming our manufacturing processes through automation You will have the opportunity to contribute to the success of Novartis, as we strive to redefine the future of pharmaceutical manufacturing, If you are excited about the prospect of utilizing your expertise to revolutionize the industry, while working alongside a dynamic team of professionals, then we would love to hear from you, About The Role Job Description Summary Develop comprehensive IT/OT solution/service design, based on business requirements, ensuring it meets quality and performance standards, Ensure that automation concept and newly designed equipment are future proof and ready for the integrations with IT/OT landscape, Coordinate and realize implementation and integration of IT/OT solutions across multiple manufacturing locations within the assigned area of responsibility, Ensure that design and implementation adhere to stability, scalability and GxP requirements, Ensure that operational support model is established efficiently for the implemented global IT/OT solutions, Contribute to continuous improvement initiatives to enhance IT/OT solutions, services and processes Take the initiative on leading the improvements in your direct area of responsibility, Major Accountabilities Responsible for detailed design, development, delivery and qualification of IT/OT system solutions and their integration for a given project / use case, in alignment defined solution architecture, and create the detailed process designs necessary to operate the solution on a day-to-day basis, Execute project related activities in accordance with the lifecycle, budget, schedule and compliance requirements, Collaborate with internal and external stakeholders to deliver technical solutions to manufacturing sites, Ensure designs produced adhere to solution architectural design, roadmap and support the development, execution and operations of software/service Facilitate peer reviews and obtain business sign-off for detailed designs, Consider the overall user experience and cost when designing and implementing solutions and services, Take accountability for adhering to Security and Compliance policies, Support internal and external audits, if necessary, Maintain stable operations for implemented global IT/OT solutions Lead business case development process and endorsement of prepared investments, Lead or contribute to the market evaluation and solution (IT/OT systems and equipment) selection process, Essential Requirements >10 years of technical experience in delivering global solutions to the customers, preferably in the aera of automation engineering in manufacturing processes, > 5 years hands-on experience of automation technologies and software platforms (e-g SCADA, Historian, MES) Knowledge of industry standards and protocols for communication and data exchange in manufacturing operations (e-g OPC, MQTT), Good understanding of manufacturing operations and processes, Experienced with defining Automation concept, green field investments and shop floor equipment selection or design is an advantage, Working experience in a GxP environment is an advantage, Leveraging digital technology / big data, Collaborating across boundaries, We offer permanent employment with 6 months of probation period Submit your application with the CV in Slovenian and English language, Youll Receive Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Wellbeing), Unlimited learning and development opportunities, Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve, 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 patientslives Ready to create a brighter future togetherhttps:// novartis / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for youSign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork novartis /network Benefits and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: https:// novartis /careers/benefits-rewards

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provide constructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop their professional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagement within the team Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills Mandatory Skills: SAP FS-CM Functional. Experience8-10 Years.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Sr Spec, IT RA Global Apps (Grade 17) Location: India (Remote/Hybrid Options Not Available) Company: Vantive Corporation About Vantive Vantive Corporation is a global leader in vital organ therapy healthcare, delivering innovative products, digitally enhanced solutions, and advanced services to support dialysis and ICU-based critical care Spun off from Baxter Kidney Care in February 2025, Vantive is committed to transforming kidney care and beyond, impacting over 1 million patient interactions daily in 100+ countries, We are seeking a Senior Specialist, IT QA RA Global Apps to serve as a System Owner and Functional Lead, responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle, This role requires hands-on experience with regulatory solutions such as Veeva RIM Vault or other Regulatory applications, Position Overview As the Sr Specialist, IT RA Global Apps, you will: Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements, Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions, Lead system validation, testing execution, and change management in a regulated environment, Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams, Act as the primary liaison between IT, business process owners, and external vendors, Key Responsibilities System Ownership & Governance Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements, Implement solutions that align with business needs and regulatory requirements, Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records, Ensure systems remain in a validated state throughout their lifecycle, Functional Business Analysis & Solution Design Gather, analyze, and document business requirements, workflows, and process improvements, Translate business needs into functional and technical specifications, Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications, Ensure solutions are scalable, compliant, and aligned with Vantives digital transformation strategy, Validation, Testing & Compliance Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards, Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes, Manage risk assessments, audits, and regulatory inspections related to system validation and compliance, System Maintenance, Enhancements & Issue Resolution Oversee system upgrades, patches, and maintenance, recommending enhancements as needed, Manage issue triage, root cause analysis, and resolution for system defects, Work closely with business process owners to ensure applications align with operational needs, Coordinate with vendors and internal teams for system support and enhancements, Stakeholder Collaboration & Project Support Act as a key liaison between IT, Quality, Regulatory, and business stakeholders, Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives, Provide end-user training and support, ensuring smooth adoption of system enhancements, Assist with project management tasks, ensuring timely delivery of IT solutions, Technical Skills & Experience The Ideal Candidate Should Have a Strong Technical Foundation With Hands-on Experience In Enterprise Application Support, Configuration, And Deployment Key Technical Competencies Include Programming & Scripting: Basic understanding of Java, Dot net, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries, Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment, Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts Cloud Computing and Data Management: Familiarity with SaaS environments (e-g , Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions, Regulatory Domain: Hands-on experience with platforms like Veeva Vault QMS, TrackWise Digital Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc regulatory authorities, global registration of products, The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications, Soft Skills Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance, Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders Ability to translate technical concepts into actionable insights for non-technical teams (e-g , explaining validation requirements to QA), Project Management: Basic project management skills to coordinate system upgrades (e-g , Veevas 3 annual releases), implementations, or process improvements Familiarity with methodologies like Agile or Waterfall, often used in IT projects, Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits, Qualifications & Experience Must-Have Qualifications 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry, Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications, Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance, Ability to develop and execute test scripts, validation plans, and system documentation, Technical knowledge of SQL, system integrations, and application configuration, Bachelors degree in Computer Science, Information Systems, or a related field, Preferred Qualifications Experience with Veeva,Salesforce, AWS, Azure, or cloud-based environments, Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Consultant, IT EHS/QA Apps About Vantive Vantive Corporation is a global leader in vital organ therapy healthcare, delivering innovative products, digitally enhanced solutions, and advanced services to support dialysis and ICU-based critical care Spun off from Baxter Kidney Care in February 2025, Vantive is committed to transforming kidney care and beyond, impacting over 1 million patient interactions daily in 100+ countries, We are seeking a Consultant, IT EHS/QA Apps to serve as a Technical and Functional Lead, responsible for ensuring EHS and Quality global applications meet business requirements and remain in a validated state throughout their lifecycle, This role requires hands-on experience with quality solutions such as TrackWise, LabVantage LIMS, Benchmark SaaS, or other Quality & Regulatory applications, Position Overview As The Consultant, IT EHS/QA Apps, You Will Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements, Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions, Lead system validation, testing execution, and change management in a regulated environment, Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams, Act as the primary liaison between IT, business process owners, and external vendors, Key Responsibilities Technical Leadership & System Support Lead the technical configuration, maintenance, and optimization of EHS and Quality systems like TrackWise (QMS), LabVantage LIMS, and Benchmark SaaS Provide technical expertise in AWS-based cloud solutions, SaaS platforms, and on-prem EHSS application architectures, Support the implementation of EHSS dashboards, analytics, and reporting tools to provide real-time compliance insights, Analyze, troubleshoot, and resolve technical issues, ensuring high availability and performance of applications, Work closely with business stakeholders, vendors, and IT teams to align solutions with business needs, Application Development & Integration Manage and support EHS and Quality applications used for compliance tracking, incident management, occupational health, and environmental sustainability reporting Support and oversee application enhancements, upgrades, and deployments in compliance with IT governance policies, Collaborate with developers, system architects, and business analysts to design and implement solutions that integrate with other enterprise systems (ERP, HRIS, and BI tools), Ensure seamless data flow between systems through API integrations, middleware, and ETL processes, System Ownership & Governance Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements, Implement solutions that align with business needs and regulatory requirements, Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records, Ensure systems remain in a validated state throughout their lifecycle, Functional Business Analysis & Solution Design Gather, analyze, and document business requirements, workflows, and process improvements, Translate business needs into functional and technical specifications, Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications, Ensure solutions are scalable, compliant, and aligned with Vantives digital transformation strategy, System Administration & Continuous Improvement Proactively monitor, maintain, and optimize application performance, security, and compliance, Identify and recommend improvements, automation opportunities, and best practices to enhance system efficiency, Train and mentor junior IT team members and provide technical leadership in the EHSS & Quality IT space, System Maintenance, Enhancements & Issue Resolution Oversee system upgrades, patches, and maintenance, recommending enhancements as needed, Manage issue triage, root cause analysis, and resolution for system defects, Work closely with business process owners to ensure applications align with operational needs, Coordinate with vendors and internal teams for system support and enhancements, Stakeholder Collaboration & Project Support Act as a key liaison between IT and EHSS and Quality business stakeholders, Support global Quality and EHSS IT projects, including new system implementations and digital transformation initiatives, Provide end-user training and support, ensuring smooth adoption of system enhancements, Assist with project management tasks, ensuring timely delivery of IT solutions, Technical Skills & Experience The Ideal Candidate Should Have a Strong Technical Foundation With Hands-on Experience In Enterprise Application Support, Configuration, And Deployment Key Technical Competencies Include Programming & Scripting: Basic understanding of Java, Dot net, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries, Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment, Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts Cloud Computing and Data Management: Familiarity with SaaS environments (e-g , Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions, Regulatory Domain: Hands-on experience with platforms like TrackWise Digital, LabVantage LIMS Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc egulatory authorities, global registration of products, The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications, Soft Skills Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance, Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders Ability to translate technical concepts into actionable insights for non-technical teams (e-g , explaining validation requirements to QA), Project Management: Basic project management skills to coordinate system upgrades (e-g , Veevas 3 annual releases), implementations, or process improvements Familiarity with methodologies like Agile or Waterfall, often used in IT projects, Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits, Qualifications & Experience Must-Have Qualifications 8+ years of experience in IT application support, preferably in regulated healthcare, pharma, life sciences, or EHSS industries, Hands-on experience with applications such as Benchmark Gensuite, TrackWise (QMS) and LabVantage LIMS or other EHSS/Quality applications, Strong knowledge of AWS (including cloud security, deployment, and infrastructure management), Experience with SaaS platforms, system integration, APIs (REST/SOAP), and middleware solutions, Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance, Ability to troubleshoot complex technical issues, perform root cause analysis, and provide long-term solutions, Excellent analytical, communication, and problem-solving skills, Certifications in AWS, EHSS/Quality systems, or ITIL are a plus, Bachelors or Masters degree in Computer Science, Information Systems, or a related field, Preferred Qualifications Experience with SQL, Dot net, Java, or scripting languages for system troubleshooting and automation, Familiarity with ITSM tools (e-g , ServiceNow) and Agile methodologies, Knowledge of business intelligence and reporting tools (e-g , Tableau, Power BI) for Quality and EHSS applications, Experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments, Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies) Having knowledge on Computer system Assurance (CSA) Experience in the validation of software and tools in a FDA regulated environment. (e.g, SAP, Solution Manager, EDMS, LIMS, PLC/SCADA systems etc.) Good to have experience on infrastructure qualification documentation- QP, IS, IQ, RTM Basic understanding of cyber security, Public Cloud Platforms such as AWS, Azure, IT Network components is a plus point. Experience of authoring and reviewing validation documentation and SOPs to maintain compliance Ensure documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies as per cGxP Experience in risk assessment during the implementation and operation of IT solutions. Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and SOPs. Review the accuracy and completeness of software validation deliverables created by other process teams CSV deliverables like of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment and validation documentation like SOPs, Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQ/OQ/PQ Test Protocols for accuracy, consistency, clarity, and completeness Understand Deviation, how to perform its investigation and propose CAPA for the deviation. Handled change management and aware of writing change requests. Experienced in working with validation tools such as HP ALM/Validator/Valgenesis Ability to lead projects end-to-end, including stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Manage multiple concurrent tasks and be flexible. Experience in facing internal quality audits, vendor audits and also providing support during audits by external auditors like US FDA in validation perspective. Mandatory Skills 21 CFR part 11, EU Annex 11, GAMP MS Office Suite- Word, Excel, PowerPoint Good verbal, and written communication skills in English Good to have Knowledge of 21 CFR Part 210, 211, 820, EU MDR, SOX, CSA Certifications such as ISO 27001, Cloud certification, Testing ISTQB, TMMi Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.

Job Title: IT Manager - Infrastructure, Networking & GxP Systems Location: Sarigam Vapi, Gujarat Department: Information Technology Job Summary: We are seeking an experienced IT Manager to lead the IT infrastructure, networking, and production/QC instrumentation functions within our pharmaceutical manufacturing facility . The ideal candidate will be responsible for ensuring compliance with USFDA, GxP, CFR Part 11, and other regulatory IT requirements , while managing IT operations to support manufacturing and quality control. Key Responsibilities: 1. IT Infrastructure & Networking Management Oversee IT infrastructure , including servers, storage, networking, and data centers . Manage enterprise LAN/WAN, VPN, and cybersecurity solutions . Ensure high availability and performance of IT systems supporting production and QC. Work with external vendors and service providers for IT support and upgrades. 2. Production & QC Instrumentation Support Manage and support GxP-compliant IT systems used in manufacturing and quality control (QC) . Ensure seamless integration of production instruments (e.g., PLCs, SCADA) with enterprise IT systems. Oversee QC instrumentation (e.g., HPLC, GC, UV, FTIR, and other lab equipment) from an IT compliance perspective. Ensure 21 CFR Part 11 and data integrity compliance for QC systems. 3. Regulatory Compliance & IT Validation Implement IT policies and procedures to comply with USFDA, MHRA, EU GMP, WHO, and other regulatory bodies . Lead IT validation and qualification (IQ, OQ, PQ) for production and QC systems. Ensure audit readiness and participate in regulatory inspections related to IT systems. Maintain IT SOPs, risk assessments, and CAPA documentation . 4. Security & Business Continuity Implement and maintain IT security frameworks (e.g., ISO 27001, NIST). Ensure backup, disaster recovery, and business continuity plans are in place. Monitor and respond to IT security incidents and ensure data protection . 5. Stakeholder Collaboration Collaborate with Production, QA, QC, Regulatory Affairs, and Engineering teams to align IT with business goals. Required Qualifications & Experience: Bachelors/Masters degree in Information Technology, Computer Science, or a related field . 10+ years of experience in IT management within a pharmaceutical manufacturing site Expertise in IT infrastructure, networking, and cybersecurity . Experience with GxP-compliant systems, 21 CFR Part 11, and data integrity requirements . Familiarity with SCADA, LIMS, Empower, and other lab automation systems . Strong understanding of pharmaceutical regulatory requirements (USFDA, EU GMP, MHRA, WHO, etc.) . Hands-on experience in IT validation, CSV (Computer System Validation), and audit management . Excellent leadership, communication, and problem-solving skills . Language Proficiency: Good communication skills Familiar with Hindi , Gujarati and English Preferred Certifications: CISA / CISM / CISSP (for IT security & compliance). ITIL GAMP 5, 21 CFR Part 11, Data Integrity training . Warm Regards, Jolly Nayak 3POINTHRM

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.) Experience in ensuring the compliance of GxP application validation and Infrastructure Qualification Successful cross-divisional/functional work with complex international teams Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, interpersonal skills, and critical thinking COMPANY : SANDOZ LOCATION : HYDERABAD CONTRACT FOR 6 MONTHS WILL BE RENEWED ON PERFORMNCE SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN

About The Role Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. ? Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. ? Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provide constructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop their professional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagement within the team ? Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills ? Mandatory Skills: SAP FS-CM Functional. Experience5-8 Years. Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality Assurance Manager Regulatory Compliance Ensure software and AI systems comply with USFDA (21 CFR Part 11, 820), GDPR, HIPAA, ISO 13485, and other global standards. Stay updated on evolving healthcare AI regulations and integrate them into QA practices. Prepare for and support audits by regulatory bodies, clients, and third parties. Computer System Validation (CSV) Lead development and maintenance of CSV protocols (IQ, OQ, PQ) for software and AI systems. Ensure validation documentation aligns with GxP standards and is audit-ready. Collaborate with IT and development teams on system updates and new features. QA Strategy & Leadership Develop and implement QA strategies using risk-based validation approaches. Manage and mentor QA teams, fostering a quality-focused culture. Monitor KPIs for software and AI quality and compliance. Process Improvement Create and maintain SOPs for QA, CSV, and AI validation. Conduct root cause analysis and implement CAPAs. Drive initiatives to improve system performance, security, and reliability. Cross-Functional Collaboration Partner with product, development, and AI teams to integrate quality into the SDLC. Translate client and stakeholder requirements into actionable QA plans. Support implementation and post-deployment activities to ensure satisfaction. Risk Management Conduct risk assessments per ISO 14971 and ICH Q9, addressing AI-specific risks (e.g., model bias). Mitigate risks related to data integrity, security, and compliance. Training & Documentation Provide training on QA, CSV, AI validation, and compliance. Maintain thorough documentation of validation activities, audit trails, and quality records. Qualifications Minimum of 10+ years of experience in quality assurance, with at least 5 years in a managerial role within a clinical trial software, CRO, Pharma, Biotech, or Medtech environment. Extensive experience with Computer System Validation (CSV) in a regulated industry. Proven track record of managing QA for software used in global clinical trials. Education: Bachelor's degree in Life Sciences or a related field. Advanced degree (e.g., Masters) or certifications (e.g., ASQ CQA, ISTQB, Six Sigma) preferred. Technical Skills: In-depth knowledge of USFDA regulations (21 CFR Part 11, Part 820), GDPR, HIPAA, ICH-GCP, and ISO standards (e.g., 13485, 14971), including AI-specific guidelines. Proficiency in CSV methodologies and tools (e.g., GAMP 5 framework). Familiarity with clinical trial software platforms (e.g., EDC, IWRS, eTMF, CTMS) and AI-driven solutions in clinical research. Soft Skills: Strong leadership and team management abilities. Excellent problem-solving, analytical, and decision-making skills. Exceptional communication skills, with the ability to liaise with technical teams, AI specialists, regulators, and clients. Detail-oriented with a proactive approach to quality and compliance. Why Join Us? Impactful Work : Contribute to cutting-edge AI-enabled solutions that accelerate clinical trials and improve global healthcare outcomes. Innovative Culture : Be part of a dynamic team that embraces new ideas, challenges the status quo, and drives innovation. Growth Opportunities : Access professional development opportunities in a rapidly growing company committed to employee success. Work-Life Balance : Enjoy a supportive work environment with flexible work arrangements.

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

The Gen AI Team Lead holds a pivotal position within the DigitalX organisation, responsible for multiple value teams under the EnablementX hub. This role involves leading and managing these teams, steering the PODs strategic and tactical goals, and ensuring alignment with the aspirations of the DigitalX leadership. Essential duties include coordinating value teams, developing and implementing roadmaps, coaching team captains, guiding backlog grooming, leading POD management standups and retrospectives, consolidating value team statuses at the POD level, and working closely with the hub leadership team. Responsibilities: Lead and guide teams and team captains, assisting in the planning and execution of tasks. Foster a POD culture that values experimentation and ownership. Collaborate and coordinate with employees across all levels to prioritise and align POD activities and deliverables. Aim to create a unified team within the POD, ensuring everyone works together towards their objectives. Facilitate meetings for discussions, including brainstorming, problem identification, and solution development. Identify and address any risks or issues related to the POD. Adhere to and promote the DigitalX operating model along with its processes and policies. Provide regular coaching and feedback to POD members. Report POD progress to DigitalX leadership. Offer input on people development and performance to relevant DigitalX leaders. Location(s) Bengaluru, India Requirements Required Qualifications: BA/BS in Computer Science, Information Technology, or equivalent experience required. Minimum of 8-10 years related experience in AI and ML space Strong use of Microsoft Office applications and agile project management toolsets. Excellent judgment and organization skills. Preferred Qualifications: Advanced Degree: A Master's degree in fields like Data Science, Computer Science, Bioinformatics, or a related quantitative field is essential. Technical Skills: Extensive Machine Learning/Deep Learning Experience: Significant hands-on experience with machine learning (ML) and deep learning, particularly with Large Language Models (LLMs). Proficiency in LLM fine-tuning, training, and building Retrieval-Augmented Generation (RAG) systems. Programming Skills: Strong proficiency in programming languages like Python, R, and SQL. Experience with relevant frameworks and libraries (e.g., PyTorch, Keras). Cloud Computing: Understanding of cloud-based data platforms and technologies (e.g., AWS, Azure, Google Cloud). Software Engineering and Platform Engineering: Experience in large scale platform development and deployment Pharmaceutical Industry Knowledge: GxP and Regulatory Compliance: Familiarity with Good Practices (GxPs), regulatory requirements, and quality standards in the pharmaceutical industry. Understanding of the drug discovery and development process, clinical trials, and regulatory submissions. Bioinformatics and Computational Biology: Knowledge of bioinformatics and computational biology, particularly in relation to drug discovery and development. Leadership and Soft Skills: Strategic Thinking: Ability to develop and implement AI strategies aligned with business goals. Cross-Functional Collaboration: Strong collaboration skills to work with diverse teams, including data scientists, researchers, and business stakeholders. Communication : Excellent written and verbal communication skills to convey complex technical information to both technical and non-technical audiences. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas Responsible Flexibility Guidelines.

Job title TOSCA automation Tester Job mode : Remote Location : Any were in India Work mode : Long term Contract More than 1 year Note : This is totally Remote in India need to travel once in a Month Near by location to client place Job Description: Strong have analytical and problem-solving skills as well as the ability to decompose complex problems and perform root cause analyses in troubleshooting customer issues in tosca. 8-10 Years of hands-on experience in Tosca Should have knowledge on DEX integration Should have knowledge on day-to-day activity like repo creation, User access management and other operations activity Should have knowledge on Windows server for performing activities like SSL certificate renewal Should have working knowledge on TOSCA development as well as execution Should have knowledge testing process (GxP & Non-GxP) from automation prespective

Role & responsibilities PAYROLL ORGANIZATION : VALUE INNOVATION LABS https://valueinnovationlabs.com/ Preferred candidate profile Title: Technical Product Owner Work Location - Bangalore Qualifications: • Bachelors degree in Computer Science, Information Technology, Business Administration, or a related field, or equivalent by experience. Masters degree or relevant certifications are a plus. • 5+ years of experience in product management or product ownership, with at least 3 years focused on Governance Risk and Compliance, enterprise risk management technologies or similar solutions. • Experience shaping integrated risk management dashboard, providing centralized views of risk activities and outcomes to management across various risk domains is required. • Experience of working with low-code/no-code solutions (including change control governance in such tools) and skills with JSON and REST APIs would be a significant differentiators. • Understanding and experience of Risk Quantification tools and techniques and the underlying mathematical models would be a significant differentiator. • Proven experience working in an agile development environment with a solid understanding of agile methodologies and principles. • Excellent communication and interpersonal skills, with the ability to effectively engage and influence stakeholders at all levels. • Strong analytical and problem-solving skills, with a data-driven approach to decision-making. • Ability to work independently and collaboratively in a fast-paced, dynamic environment. Preferred Qualifications: • Familiarity with other ServiceNow modules and integrations, particularly in IT Service Management (ITSM), Third Party Risk and Governance, Risk, and Compliance (GRC). • Experience in enterprise risk assessment, risk mitigation strategies, and compliance frameworks (e.g., ISO 31000, COSO). • Knowledge of industry regulations and standards relevant to risk management (e.g., GDPR, SOX, GxP). Please share the updated resume on puneet@mounttalent.com or else call & Whatsapp at 9910092142.

Work profile: Plant IT Operations (Pharma and Biotech) Job Location: Bangalore Qualification: Diploma or Degree in Engineering Experience: 7-10 years (L2) Duration : 1 year contract Role & responsibilities: Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for enterprise-level applications, addressing technical issues and maintaining operational continuity. Configuration of software, peripheral devices, and upgradation and troubleshooting for enterprise applications hosted on Windows servers. Capable to handle GxP and non-GxP incidents and tickets related to backups, file management, user management, and security within SLA, and hardware and software maintenance to improve network performance and reduced downtime. Coordination with cross functional team for requirement gathering, review and finalizing technical specifications for IT infrastructure systems. Basic understanding business requirements from users. System administration for GxP application users and project Creation/Disable/modification records. Maintain the disaster recovery plan and backup. Should have good knowledge of QMS process include handling investigations, Change controls and deviations. Backup and Restoration for GxP Systems for Laboratory and Mfg. systems. Should be capable to Coordinate with external engineers/vendors of QC and ensure the services of equipment and applications. Provide technical and functional support to the teams, maintaining the team and giving support to end users for day-to-day activities along with reviewing team Daily reports weekly reports, and Monthly reports and preparing necessary documents. Configuring and troubleshooting of the Network and printers, Configuring and troubleshooting of LAN on Windows platforms. Installation and troubleshooting of Desktops and Workstations.

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines 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 execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved 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 data engineering teams to drive validation activities and meet project deadlines. ? Track 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. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience 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: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

MDM Business Performance Manager What you will do Let’s do this. Let’s change the world. In this vital role you will lead the optimization of master data processes across Amgen’s global operations, ensuring data quality, consistency, and governance. They are responsible for driving continuous improvement initiatives, and strategic projects, focusing on improving data accuracy, reducing process inefficiencies, and aligning data management practices with business objectives. This role will collaborate with IT, Supply Chain, and other key stakeholders to ensure that MDM processes support operational needs and regulatory compliance. Roles & Responsibilities: Lead the development and implementation of MDM governance frameworks and associated metrics/KPIs, ensuring alignment with regulatory and business requirements. Drive process automation and improvements to enhance data accuracy and reduce manual input errors. Lead all aspects of the integration of master data across systems and ensure consistency across Amgen’s global operations. Collaborate with IT, Supply Chain, and Commercial Operations to align data management practices with business needs. Handle key MDM projects, including system upgrades, process improvements, and data cleansing initiatives. Ensure compliance with industry regulations and internal policies. Provide leadership on MDM standard methodologies and serve as a subject matter expert for cross-functional teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Bachelor’s degree and 5-7 years of data management experience, with expertise in healthcare or biotech industries, and extensive knowledge of data governance frameworks (GDPR, HIPAA, GxP). Proven leadership in implementing and leading large-scale MDM processes and driving operational excellence initiatives to improve data quality, accuracy, and efficiency as evidenced by KPIs. Expert-level proficiency in SAP and enterprise data management tools (e.g., SAP MDG, Informatica) with experience leading complex system integrations and process optimizations. Strong communication and leadership skills, able to handle cross-functional teams and present data strategies and insights effectively to senior leadership. Advanced data analytics and visualization expertise (e.g., Power BI, Tableau) to drive actionable insights and decision-making across the organization. Preferred Qualifications: Must-Have Skills: Expertise in designing and handling MDM frameworks and KPIs, improving data quality, and streamlining processes across large-scale operations. Advanced knowledge of SAP, Informatica, and other enterprise data tools, with experience leading systems integration and automation initiatives. Strong leadership and communication skills, with the ability to lead diverse teams and collaborate with stakeholders across business units. Good-to-Have Skills: SAP S/4, SAP MDG, SAP TM Experience in Data Governance Project management experience 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. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Mgr Information Systems What you will do Let’s do this. Let’s change the world. In this vital role you will responsible for leading the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a lead tester and validation expert with functional and system knowledge for Clinical Data Management, Interactive Response Technology (IRT) solutions. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions related to the RBM / RBQM system(s) within Clinical Data Management and Interactive Response Technology (CDMIRT) product team, in order to create test scripts. Build test scripts per implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues Perform regression testing to verify the changes do not negatively impact existing system functionality Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Identify and resolve technical challenges/bugs effectively Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Support the creating and implementation of automated testing frameworks to improve efficiency and consistency 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 OR Master’s degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field Preferred Qualifications: Must-Have Skills: Knowledge of clinical trial processes specifically software validation processes Experience with testing methodologies and automation practices Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management Experience in conducting testing activities in GxP systems Good Problem-solving skills - Identifying and fixing bugs, adapting to changes Good communication skills - Explaining design decisions, collaborating with teams Experienced in Agile methodology Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems Solid understanding of SQL scripting Experience in RBM/RBQM systems Experience with cloud-based technologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) 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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Sr Associate IS Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a Quality assurance tester and validation analyst for the Clinical Data Management and Interactive Response Technology (CDMIRT) product team. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Build test scripts per implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues Perform regression testing to verify the changes do not negatively impact existing system functionality Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Identify and resolve technical challenges/bugs effectively Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Support the creating and implementation of automated testing frameworks to improve efficiency and consistency 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 Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor’s degree with 5-8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Must-Have Skills: Knowledge of clinical trial processes specifically software validation processes Experience with testing methodologies and automation practices Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management Experience in conducting testing activities in GxP systems Good Problem-solving skills - Identifying and fixing bugs, adapting to changes Excellent communication skills - Explaining design decisions, collaborating with teams Experienced in Agile methodology Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems Working knowledge of SQL scripting Experience in RBM/RBQM systems Experience with cloud-based technologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) 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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Validation Engineer I What you will do Let’s do this. Let’s change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Quality Associate Director What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for the development and execution of core technology-based competencies focusing on Artificial Intelligence to enable the Quality strategy aligned with our long-term aspiration and follows the expectations of international regulatory agencies. Support the Quality vision and mission for the Center aligned with Amgen’s mission to serve patients. Support Amgen Site Quality Head in the development and implementation of a multi-year Quality technology roadmap aligned with Amgen’s standards and overall strategic imperatives. Ensure applicable activities align with GxP regulatory requirements, promoting execution excellence and a strong Quality culture. Collaborate with local and global partners to ensure Amgen India future regulatory inspection readiness. Deliver Quality service level agreements with other Amgen sites and key collaborators. Partner with cross-functional digital and technology teams and serve as a Quality point of contact to develop and establish core Amgen India technological capabilities focusing on Artificial Intelligence. Leverage emerging technologies, such as artificial intelligence, to enhance Quality systems, regulatory compliance and drive operational efficiencies Attract and recruit top talent aligned with the overall Quality organization hiring plan. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of Amgen’s Leadership Attributes. Responsible for managing, growing, and developing a core digital technologies team in India, ensuring global ways of working are imbedded in the local organization. Develop and deliver team goals aligned with Amgen Quality & Corporate goals. Oversee unit expenditures and manage budget to ensure adherence to financial targets. 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 and 3 years of leading teams focused on the application of emerging technologies to Quality systems OR Master’s degree and 10 to 14 years of leading teams focused on the application of emerging technologies to Quality systems OR Bachelor’s degree and 14 to 16 years of leading teams focused on the application of emerging technologies to Quality systems OR Diploma and 18 to 20 years of leading teams focused on the application of emerging technologies to Quality systems Preferred Qualifications: A consistent record of prior experience leading teams focused on the application of emerging technologies to Quality systems. 10+ experience in leadership roles in the pharmaceutical industry. PhD, MS or BS in life sciences or Engineering degree preferably in Computer Science/Artificial Intelligence. Demonstrated ability to drive and contribute to large digital transformation programs and collaborate seamlessly with cross-functional matrixed teams Demonstrated expertise in the application of digital technologies (including AI) to Quality operations. Experience in digital application lifecycle management, and Agile development methodologies. Experience in people management and passion for mentorship, culture and fostering the development of talent. Strong experience in Quality Management Systems oversight and implementation. Ability to lead change management and transformation of a Quality function. In depth knowledge on the application of emerging technologies to global GxP regulations impacting quality activities in the pharmaceutical industry. Excellent verbal and written communication skills/writing skills; active listening skills; attention to detail. Strong process/business writing skills. Ability to translate business and key collaborator feedback into accurate and efficient processes using unambiguous language and format. Strong analytical/critical-thinking and decision-making abilities. Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Fluency in English (written and spoken). Ability to embody the Amgen leadership attributes which are: InspireCreate a connected, inclusive, and inspiring work environment that empowers talent to thrive AccelerateEnable speed that matches the urgency of patient needs by encouraging progress over perfection IntegrateConnect the dots to amplify the collective power of Amgen to get results for patients, staff, and shareholders AdaptLead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Title - Lead- SAP Quality Management (SAP QM) Experienced Required- 8-12 Years Role Description: This role shall support global supply chain business team n various areas such a Supply Chain, Logistics, Shipping, inventory Management, Production Supply and related processes The applicant should also have broad knowledge of SAP The applicant should have the ability to support advanced business functions, translate complex business requirements into solution designs, and build and implement systems and technical solutions for operations. Job Requirements: Around 8+ years of experience in the SAP supply chain focused on SAP ERP design, implementation (at least 3 end to end implementation project) and support Business Process Knowledge of topics viz. Quality Planning, Quality inspection, Quality Control, Quality certificates Quality Notifications Stability Studies, Batch Management etc. Experience of integrating SAP QM with External system 3PLs like MES, Trackwise, LIMS, Labware, Lab Vantage etc, and with other SAP modules, GXP and SOX requirements Experience as Solution Architect in the multiple programs of global scae Experience in Business Blue Printing, Design, Prototyping, Functional Analysis, Configuration, Gap Analysis, Conversion Migration Testing Training Cutover, Go-Live and Post Go-live Support activities, driving Business process workshops and Fit/GAP analysis Deep Knowledge and expertise in Quality Management BPML Good experience in Data migration process and ETL Tools Domain experience in Quality Management with S/4HANA certification (preferred). Experience in Deal Pricing Transformation Deal Estimations Should have experience of Change Management, Task Planning, Project Reporting, Resource Management, Process improvement, Supervising. Strong relationship building skills Job Responsibilities : Establish relationships with Supply Chain (primarily Logistics, Warehouse, Shipping but also other Operations functions and Quality) and super users globally. Lead the engagement efforts at different stages from Problem definition to diagnosis to solution design, development deployment, contribute to unit level Organizational initiatives Design, Build Optimize End to End SAP Quality Management Processes for customers enterprise. Collaborate with business users in Supply Chain Dept. and other departments when needed, to gain a deep understanding of their business processes and requirements. Design, develop and test system solutions to address business requirements, in alignment with the global solution template. Collaborate with business teams globally to gain a deep understanding of business processes, requirements and develop test the processes to address business requirements. Develop functional specifications for custom developments and collaborate with the development team to get those built and tested.

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contractual framework. As a visionary leader, you will inspire and guide our team of experts to deliver high-quality and reliable information technology services. Working closely with the latest systems, software products, and networked devices, you will align our solutions perfectly with our customers' evolving business needs. Your deep knowledge of the services we provide paired with your understanding of customer businesses, will enable you to propose and implement tailored solutions that exceed their expectations. You will be an integrated part of our customer account structure, fostering strong relationships with our customers and collaborating closely with our Delivery Partner & Customer Partner. Together, you will create an environment that promotes innovation, collaboration, and customer success. By owning the technical and managerial support for our plant IT team, field engineers, technicians, system administrators, subject matter experts, and product support personnel, you will empower them to deliver, manage, maintain, and deploy IT services effectively. When troubleshooting incidents, problems, changes, and escalations, you will be at the forefront, providing swift support to fix any issues that may arise in malfunctioning services, operations, software, or equipment. Your expertise will ensure that our systems run smoothly, offering our customers a seamless experience. As a plant operations Lead, you will have the unique opportunity to collaborate with an exceptional team of Delivery Partners, Architects, and SREs (Site Reliability Engineers). You will co-create, design, deploy, and maintain reliable, available, and future-proof systems and services. Your innovative ideas and leadership skills will play a vital role in shaping the technological landscape of our organization and the industry as a whole. If you are ready to make an impact, drive customer success, and be at the forefront of technological advancements, this is the role for you. Join our team and be part of an exhilarating journey as we reshape the IT services landscape with creativity, passion, and excellence. Your Future at Kyndryl Kyndryl has a global footprint, which means that as a Delivery Management Lead at Kyndryl you will have opportunities to work on projects and collaborate with colleagues from around the world. This role is dynamic and influential – offering a wide range of professional and personal growth opportunities that you won’t find anywhere else. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Skills and Experience Over 12 years of experience leading delivery teams and providing quality services to customers. Pervious experience in working with Pharma will be advantageous Strong understanding of Kyndryl competencies, managed platforms, IT services, and technology vendors. Strong understanding and knowledge of Pharam Plant IT Operations Oversee the day-to-day operations of IT infrastructure, network, applications, and support services. Ensure high availability and performance of critical systems including MES, LIMS, ERP, and SCADA. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5, GxP). Collaborate with QA/Compliance teams to support audits and inspections. Maintain cybersecurity posture in line with corporate standards and industry best practices. Lead and mentor a team of IT professionals and support staff. Manage IT budgets, contracts, and vendor relationships. Work closely with cross-functional teams including manufacturing, QA/QC, engineering, and supply chain. Experienced in leading teams through incident, problem, and change management, as well as root cause analysis. Capable of partnering with Delivery Partners and collaborating with SREs to achieve positive customer outcomes. Hands-on knowledge of AIOps with an automation and innovation-focused mindset. Proficient in maintaining direct and ongoing interaction with customers. • Compassionate and empowering delivery resource manager, promoting growth Knowledge of IT/OT systems, industrial networking, and cybersecurity in manufacturing. Preferred Skills and Experience •Bachelor's degree •Six Sigma, PMP, and/or ITIL certifications Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402 • Strong knowledge of Qualification and Validation project development/implementation processes. • Excellent FDA GxP understanding. • Knowledge of SoX, cGMPs, FDA and EMA guidelines. • Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000 • Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance • Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must. • Good Program/Project management skills along analytics & reporting skills with strong communication & presentation. • Ability to work with all level of clients & internal resources • Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred. JD • Point of contact for client stakeholders as well as HCL Operations team for guidance & support regarding compliance control requirements and implementation into service operations • Create & Document the control compliance plans for all services in scope • Lead Compliance processes for large Pharmaceutical Client for specific geography • Manages the infrastructure Qualification of hardware/Servers. • Maintains categorization of Off-the-shelf validation categories. • Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services • Develop & Plan internal audit calendar aligned to clients internal as well as external audit schedule • Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances • Provide agreed upon and ad-hoc reports for audits & compliance operations. • Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits • Conduct process audits for ITSM as per agreed upon process controls • Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines We are looking for functional consultants have extensive experience in GxP related policies & process definitions and enforcements.