What you will do In this vital role you will be responsible for supporting and maintaining the Veeva Vault Quality system and its hosted applications like Quality-Docs, QMS, Veeva Vault Manager and etc. The role entails fostering platform reliability and efficiency through streamlined release management and establishing a consistent DevOps and CI/CD framework. The role will be working closely with collaborators to understand support requirements and ensure that solutions are scalable, secure, and aligned with business goals. The role will be involved in defining and ensuring the validated state of the Veeva Vault Quality. Roles & Responsibilities: Develop and maintain the enterprise architecture vision and strategy, ensuring alignment with business objectives, in Veeva Vault Quality system Responsible for fostering platform reliability and efficiency through streamlined release management & execution and establishing consistent DevOps & CI/CD framework Accountable for designing and building customizations & configurations on the Platform as per the business needs including, creating custom objects, fields, workflows and SDKs Responsible for strategizing Platform Integrations while adhering to consistent integration standards and patterns, designing integration workflows, building connectors, centralizing build & run and implementing consistent DevOps model for integrations Identify and mitigate architectural risks, ensuring that the platform is scalable, secure, and resilient Maintain comprehensive documentation of the platform architecture, including principles, standards, user guides, and models Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency Work with collaborators to gather and analyze requirements, ensuring that solutions meet both business and technical needs Perform impact assessments, clearly define AS-IS and TO-BE states, and recommend platform upgrades in accordance with the new features and functionalities released by Veeva Design platform architecture that can scale to meet growing business needs and performance demands Develop and maintain logical, physical, and conceptual data models to support business needs Establish and implement data standards, governance policies, and best practices Basic Qualifications: Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelors 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 Must-Have Skills: Solid understanding of Veeva Vault Quality system and its hosted applications like Quality-Docs, QMS, Veeva Vault Manager and etc 6-8 year Global Pharmaceutical experience Solid understanding of pharmaceutical manufacturing business process and regulations Experienced in pharmaceutical regulations and specifications TeamPeople management experience Experienced in GxP process Experience with system integration and IT infrastructure Experience working in agile methodology, including Product Teams and Product Development models Proficiency in designing scalable, secure, and cost-effective solutions Good-to-Have Skills: Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Experience in developing differentiated and result solutions Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications: Veeva Vault Platform Administrator (mandatory) SAFe DevOps Practitioner (mandatory) SAFe for teams (preferred) Soft Skills: Should be able convert business requirements into technical requirements Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills

Experienced in Process Auditing and Quality Management Systems with a strong foundation in SMT and box build assembly processes, ensuring compliance with standards and continuous improvement. You Have: Diploma or graduate with 3 years of experience in SMT and box build assembly processes. Experience with process audits and QMS standards. Effective problem-solving and root cause analysis. Strong coordination and communication within teams. It would be nice if you also had: Knowledge of Six Sigma or Lean Manufacturing principles. Contribute to enhancing quality and reliability through effective process audits and adherence to QMS standards. Identify and implement process improvements to reduce defects and improve efficiency in SMT and box build operations. Support problem-solving initiatives using root cause analysis and data-driven decision-making. Maintain documentation and standard operating procedures to ensure consistency and compliance. Learn advanced methodologies in process engineering and quality control to increase technical proficiency. Gain deeper understanding of end-to-end manufacturing workflows, including integration of new technologies. Develop leadership skills by supporting junior staff and engaging in cross-team knowledge sharing.

Dear Candidate, Greetings from Grupo Antolin India Pvt. Ltd. We are one of the largest players in the car interiors market internationally and number 1 worldwide supplier of headliner substrates. We offer products with high added value to outfit automobile interiors: Overhead Systems, Doors, Cockpits, Lighting, Electronic Systems & Integrated Products. We dominate the complete component cycle from component conception and design, through development and validation to parts industrialization and sequenced delivery. We have an opening with us for the position of Quality Manager in for our Grupo Antolin India Pvt. Ltd. (Chakan Plant) Responsibilities: To boost the Quality Culture and continuous improvement focusing the company operations in the Customer Satisfaction. Define the quality assurance and improvement plan of the company managing all activities described in the process P10. Principal Duties and Responsibilities Should define the Objective parameters against each of the KPI indicator to monitor the Performance of the Reporting team against the defined targets linked to the Management objectives QMS systems. Should have the Customer Requirements and the Quality targets defined by the customer and ensure that there is an action plan for higher/ equal or lesser than customer quality targets.. Mechanism for sharing these defects and Objectives throughout the Plant. Should be conversant with IATF requirements ,GA QMS process. IATF CSR requirements VW- Formal Q Audits , GMI -BIQS , FCA -PCPA Renault -Supplier Health Check and M&M- MSES Audit Co ordination and NC closure along with Yearly Audits- TLD ( VW in case of Concerns ) , PCPA ( Incase of TML, FCA and GMI and adhere to the Quality Routine Plan Product & Process Changes-Responsible to Track the Changes in the Process and Product as per the GA Application guide Procedure GA P 06 Knowledge of NC monitoring system for NC with Open/ Close status and action plan for delayed / Pending NC. -Customer Audits Knowledge of Quality Routines and Evaluation of P10 Process and Staff meetings , GAPS Audits. Customer claims -Should have strong Knowledge and skill on Problem solving tools and Management tools for giving guidance to the team in Problem section and mentor the weak areas --QMS -Customer Specific Action Plan review and Closure in the Portal Progress Monitor for Effectiveness and Phenomena Recurrence. Should Ensure that Customer Satisfaction with Customer Visit and Satisfaction survey sign off . Should be a Part of Phase 3 and Phase 4 Customer Documentation closure - PPCR-IPA-CPA-IPH-CPH along with the Customer PPAPA document submission in coordination with the Quality Engineering. NQC for Customer Rejections and GAPS Audit Compliance Capture Lessons Learnt and the Process Know How and its Horizontal deployment for the NQC Issues. To implemented the CSR requirements related to the EMS & OHSMS. To implemented the TQM & TPM system with the great approach. To implemented the CSR requirements related to the EMS & OHSMS. Responsible for the developing child part and the P10.3 Responsible for the DVP & NDP activity To implement lab at NABL level. Qualifications: Experience in Automotive sector at least 15 years Experience Communication skills, analytical thinking, attention to detail, problem-solving capabilities, leadership qualities, ability to influence others, a strategic approach, and a focus on continuous improvement. What can we offer you: You will be part of a highly engaged multinational with international career opportunities. We offer you a learning journey adapted to your professional experience. You will work on international projects for world- renowned companies in Automotive sector. You can find an open Environment to learn new technologies. We can offer you a competitive salary & benefits. If you are interested for the said position, kindly revert back with your updated profile on below email Id - reshma.renukar@antolin.com

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 seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Validation Lead Role Name Validation Lead Department Name Enterprise Engineering and Analytics (EEA) Role GCF 4 Job Family Software Development Engineer-Test I I Hiring Manager Name Asha Rani 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 seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s /Masters degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Role Description: The Associate, Expense Audit is responsible for reviewing expense reports to identify exceptions and validate compliance with Amgen’s policies. This role is critical to Amgen’s efforts to maintain its internal controls and to ensure accuracy of employee-submitted expense reports. Roles & Responsibilities: Perform timely and accurate audits of expense reports. Flag and escalate policy violations and compliance risks. Document findings and contribute to audit insights reporting. Support the implementation of new audit rules and exception handling procedures. Collaborate with the Customer Success team to respond to user inquiries via ServiceNow. Basic Qualifications and Experience: Bachelor’s degree with 1-3 years of financial operations (including Travel & Expense administration, Financial Planning & Analysis, Procurement, etc.) experience. Familiarity with audit or compliance functions in industries practicing GxP or other highly regulated industries. Functional Skills: Must-Have Skills: Familiarity with T&E policies and T&E management systems. Detail oriented with an aptitude for identifying non-compliance. Proficiency in recordkeeping and documentation practices. Good-to-Have Skills: Knowledge of SAP, ServiceNow, SAP Concur, or other systems. Soft Skills: Clear and concise communication skills. Time management and ability to prioritize tasks. Customer service mindset.

Role Description: The Associate, Expense Audit is responsible for reviewing expense reports to identify exceptions and validate compliance with Amgen’s policies. This role is critical to Amgen’s efforts to maintain its internal controls and to ensure accuracy of employee-submitted expense reports. Roles & Responsibilities: Perform timely and accurate audits of expense reports. Flag and escalate policy violations and compliance risks. Document findings and contribute to audit insights reporting. Support the implementation of new audit rules and exception handling procedures. Collaborate with the Customer Success team to respond to user inquiries via ServiceNow. Basic Qualifications and Experience: Bachelor’s degree with 1-3 years of financial operations (including Travel & Expense administration, Financial Planning & Analysis, Procurement, etc.) experience. Familiarity with audit or compliance functions in industries practicing GxP or other highly regulated industries. Functional Skills: Must-Have Skills: Familiarity with T&E policies and T&E management systems. Detail oriented with an aptitude for identifying non-compliance. Proficiency in recordkeeping and documentation practices. Good-to-Have Skills: Knowledge of SAP, ServiceNow, SAP Concur, or other systems. Soft Skills: Clear and concise communication skills. Time management and ability to prioritize tasks. Customer service mindset.

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issues and addressing any business-critical escalations Research vendor information to determine appropriate contact for validation Conduct vendor outreach for vendor data validation Provide accurate, compliant and timely updates for validation outreach effort Manage outreach email box and respond/resolve issues in a timely manner Coordinate with Global team to ensure validations are performed in a timely manner Support Vendor Master escalation requests for master data maintenance related to blocking/unblocking vendor records and maintain overall master data integrity Understand the link between SAP, Ariba Cloud platform and the Ariba Network Support the monitoring and maintenance of vendor master data on a regular basis, to ensure data integrity and quality Provide regular reporting on Vendor Master data Continuously improve processes and procedures to enhance efficiency and effectiveness of the vendor master process. Supplier Enablement & Purchasing Catalogs Support connectivity of Suppliers to Amgen’s procurement systems Play a central role in managing supplier engagement for new catalog setup including preparing and testing new hosted catalogs and punch-out catalogs Support any ongoing monitoring and maintenance activities of catalogs, including monitoring catalog prices to ensure high accuracy of costs Communicate with local purchasing and technical teams and the supplier to resolve operational issues with catalogs. Provide related support to various stakeholders (e.g. answer questions, give requested support/advice, conduct trainings). Basic Qualifications Master’s degree OR Bachelor’s degree and 5 years of Finance experience OR Associate’s degree and 7 years of Finance experience OR High school diploma / GED and 10 years of Finance experience Preferred Qualifications 3+ years’ experience in Procure to Pay space, particularly working with master data and customer service SAP experience Ariba experience MS office proficiency especially Microsoft Outlook and Excel/CSV Ability to manage time to respond to incoming requests and prioritize appropriately to meet SLAs Motivated and responsive to changing priorities and deadlines Highly organized and reliable with strong attention to detail, verbal communication, and interpersonal skills Strong customer service focus while having a problem-solving attitude Ability to multi-task and work within tight timelines Work independently and take ownership of assigned activities Be a team player 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 imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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.

QA Specialist What you will do In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organisations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Perform tactical batch disposition activities in support of lot release Enter and approve analytical data in LIMS Manage and drive Quality records to closure including deviation records, investigation reports Initiate Quality records for supplier related changes. Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed Provide data to the networks to support Quality Management Processes) Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Take part in operational and quality improvement initiatives, programs, and projects. Communicate effectively with partners, ensuring alignment on quality objectives and compliance needs. 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 to 6 years of experience in quality management systems or a related field OR Bachelor’s degree with 6 to 8 years of experience in quality management systems or a related field OR Diploma with 10 to 12 years of experience in quality management systems or a related field. Must-Have Skills: Working foundation in quality assurance roles. Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external collaborators across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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.

What you will do In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain aligned with industry standards and align with all regulatory requirements. Roles & Responsibilities: Advising clients on how to meet compliance requirements using a risk-based approach. Develop validation documentation and standard operating procedures for various GxP applications. Develop test protocols that thoroughly test business requirements. Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements. Work with client business functions and domain experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required Development of test / validation scripts based on software design and configurations. Develop IQ/OQ scripts as required. Doctorate degree OR Masters degree and 4 to 6 years of Life Science/Biotechnology/ Pharmacology/Information Systems experience OR Bachelors degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/ Biotechnology/Pharmacology/ Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP Experience with regulatory agencies FDA, EMEA, CFDA, and other regulatory agencies Proven leadership skills with the ability to multitask and lead multiple validation projects Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology. Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. Expertise with ALM testing and ALM software (HP) Expertise in use Veeva (all modules CDocs, QMS, RIM, DocuSign, etc) Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance. Good-to-Have Skills: Ability to work independently, excellent problem solving and professional written communications skills. Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus FDA Audit experience a plus & working with regulatory agencies Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Ability to work effectively with global, virtual teams. Excellent analytical and solving skills. Ability to prioritise successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation.

Job description Bangalore, India Job category Reg Affairs & Safety Pharmacovigilance Department Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities Act as Ownerof the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates. Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator s Brochure (IB), integrated safety summaries, abstracts and planned publications. You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required. Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications Masters in Medicine/MD post MBBS graduate is Preferred. Relevant Experience in Signal Management, Aggregate Management, ICSR. Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint). Fluent in written and spoken English. Analytical mind-set. Professional authority. Quality mind-set, well-organised and strive for excellence. Pro-active planner to meet agreed deliverables. Strong communicator (verbally and in writing). Curious and constantly looking for improvement opportunities. Team player with high degree of flexibility and service mindedness. Cross-cultural awareness. Ability and willingness to quickly adjust to changes in a continuously developing environment.

The Platform Engineering team is responsible for developing platforms and tools to enable DevOps and Quality Engineering at MSCI. As part of the Quality Center of Excellence, we develop productivity related tools, services and platforms such as the MSCI software catalog and Internal Developer Platform, in addition to managing and maintaining third-party developer workflow tools. The Platform Engineering team also leads the development of the Quality Management System, which gathers and synthesizes metrics from internal and external systems to comprehensively measure and enhance Quality at MSCI. As a backend software engineer, your responsibility will be to design, develop, test, maintain, and support resilient, production-grade enterprise services, platforms, and tools. Your Key Responsibilities Manage all aspects of the Developer Workflow (SDLC) from requirements through design, development, testing, deployment, and production support. Design and integrate REST and GraphQL APIs for seamless data flow. Develop and maintain codebases using Java Spring. Utilize Git for source code management. Implement DevOps best practices and CI/CD processes. Actively participate in Agile/Scrum teams and contribute to bi-weekly sprints.

Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR s, BPR s, master SOP s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements.

Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role Definition: Manage product regulatory compliance risks (non-emission) and ensure compliance for all Caterpillar and allied products / business and enable market access in India region*. (*) India regionIndia, Sri Lanka, Nepal, Bhutan and Bangladesh Responsibilities Actively engage / proactively work with pertinent Standards Development Organizations ( SDO) such as Bureau of Indian Standards(BIS), Indian Road Congress(IRC), Regulators, and Trade Associations (TA) to drive advocacy / draft requirements for Construction Earthmoving , Material Handling and Mining (CEMM) Industry. Identify / Stay abreast on current and upcoming India region product regulatory requirements. Assess implications of upcoming regulations on Caterpillar products, solutions, and services. Collaborate with Government affairs team, TA s and Ministry to mitigate potential compliance challenges Work with all related teams to ensure that all Caterpillar products, solutions, and services are compliant after effective date. Be part of NPI teams to proactively guide / ensure all products placed in India region market meets regulatory requirements Develop guidance documents to guide all internal teams on regulatory requirements. Periodically update all stakeholders on regulatory developments. Identify continuous improvement opportunities for processes and tools used to manage product regulatory compliance risks. Degree Requirement B.E/ B.Tech from an accredited institution is mandatory with 12+ years of relevant experience in Engineering, Marketing or other areas in the organization is preferred. Skill & Competency Descriptors Technical knowledge Deep Product and process knowledge: Level Extensive experience Working knowledge of CAT Products, Product application / usage, services & solutions provided in India region Good working experience of CAT processes (NPI, Trade, Certification) Strong communication skills - Verbal and written Experience of working with several product groups a plus Collaborating skillsAbility to work with all stakeholders in a constructive and collaborative manner. Level Working Knowledge: Demonstrates experience participating in productive collaborative processes. Initiates collaborative meetings with all pertinent stakeholders. Communicates plan / actions to manage compliance risks Supports to promote collaboration across functions, businesses, and levels. Helps solve business problems and meet business goals through collaborative processes. Risk ManagementKnowledge of processes, tools and techniques for assessing and controlling an organization's exposure to risks of various kinds; Ability to apply knowledge of risk management appropriately to diverse situations. Level Working Knowledge Proactively identifies compliance risks (non-emissions) for all Caterpillar businesses in India Leverages risk assessment models and techniques to assess compliance risks. Leverages Produces and interprets common risk assessment and management reports. Implements or manages risk management for own area. Documents the key steps of risk management and associated procedures. Product Development Knowledge of product development process and leverages knowledge to ensure compliance aspects are embedded as part of product development. Level Working Knowledge Reviews and assesses proposed solutions to mitigate compliance risks. Creates, disseminates, and maintains best practice documentation. Monitors the use and feasibility of best practices within a product development department on compliance matters Highlight any issues related to major resources and logistics for applying best practices. Willing to travel Approx. 30% Relocation is available for this position. Posting Dates: May 29, 2025 - June 5, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community .

Career Area: Human Resources : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Your Impact Shapes the World at Caterpillar Inc When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Job Summary We are seeking a skilled Total Rewards Partner _ to join our Financial Systems- Total Rewards Team This role will be based out of Bangalore-Whitefield office Caterpillar is seeking to enhance our Global Compensation team by introducing a new Total Rewards Partner to support our worldwide workforce. This role, based in Bangalore, India, presents a unique opportunity to positively influence the lives of Caterpillar employees, leaders, and the communities we serve. If you are interested in a career that emphasizes collaboration, fosters meaningful partnerships across all business levels, and has a global impact while promoting a strong team culture, we invite you to apply! What you will do Performs qualitative and quantitative research on compensation related programs to support business and talent challenges with a focus on non-bargained production facility wage analysis and salary planning for our Global workforce. Leads global compensation programs, with a focus on standardization and administration in Workday Completes external market research and analyses to understand compensation trends, provide insights and recommendations to enhance current compensation programs or potential new programs\ Administers Total Rewards programs, communicating with internal customers and partnering with external vendors Leads global compensation related projects, interacting with consultants and internal partners Ensures compliance of compensation programs and policies and manages employee data in line with company policies Compensation Management Knowledge of compensation structure, and regulations and policies related to compensation; ability to design, implement and evaluate compensation programs, policies and processes within an organization. Level Working Knowledge: Implements compensation packages for an organization's employees. Coordinates compensation activities with HR and business staff. Adheres to government and industry compensation regulations. Conducts job analysis and salary survey activities within the department. Assists in developing various compensation programs within an organization. What you will have Experience3-5+ years for compensation related experience Bachelor s degree is must. Project Management Skills along with good communication skill is must Analytical ThinkingKnowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems. InfluencingKnowledge of effective influencing tactics and strategies; ability to impact decisions within and outside own organization. Interpersonal Relationships and Effective CommunicationsUnderstanding of effective communication concepts, tools and techniques; ability to effectively transmit, receive, and accurately interpret ideas, information, and needs through the application of appropriate communication behaviors. Knowledge of the techniques and the ability to work with a variety of individuals and groups in a constructive and collaborative manner. Compensation ManagementKnowledge of compensation structure, and regulations and policies related to compensation; ability to design, implement and evaluate compensation programs, policies and processes within an organization. Additional Details: Preferred locationBangalore, India. Remote work is not acceptable. Work across time zones. Working knowledge of Workday Travel5% 5 days Work from office Mandatory Skills desired Analytical Thinking Knowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems. Level Working Knowledge: Approaches a situation or problem by defining the problem or issue and determining its significance. Makes a systematic comparison of two or more alternative solutions. Uses flow charts, Pareto charts, fish diagrams, etc. to disclose meaningful data patterns. Identifies the major forces, events and people impacting and impacted by the situation at hand. Uses logic and intuition to make inferences about the meaning of the data and arrive at conclusions. Effective Communications Understanding of effective communication concepts, tools and techniques; ability to effectively transmit, receive, and accurately interpret ideas, information, and needs through the application of appropriate communication behaviors. Level Working Knowledge: Delivers helpful feedback that focuses on behaviors without offending the recipient. Listens to feedback without defensiveness and uses it for own communication effectiveness. Makes oral presentations and writes reports needed for own work. Avoids technical jargon when inappropriate. Looks for and considers non-verbal cues from individuals and groups. Interpersonal Relationships Knowledge of the techniques and the ability to work with a variety of individuals and groups in a constructive and collaborative manner. Level Working Knowledge: Explains impact of interactions with individuals and groups. Identifies roles and responsibilities for self and others. Demonstrates an understanding of alternative points of view. Collaborates with departmental associates and management. Adapts interaction style to situations and people. Benefits Programs Knowledge of employee benefits programs, processes, issues and considerations; ability to design and implement benefits programs. Level Working Knowledge: Counsels and assists employees in benefits issues. Transfers employees information and benefits data to benefits vendors. Performs benefits administration including enrollment, claims and the termination process. Analyzes corporate benefits plans and market trends. Implements a specific type of benefits program within the organization. Compensation Management Knowledge of compensation structure, and regulations and policies related to compensation; ability to design, implement and evaluate compensation programs, policies and processes within an organization. Level Working Knowledge: Implements compensation packages for an organization's employees. Coordinates compensation activities with HR and business staff. Adheres to government and industry compensation regulations. Conducts job analysis and salary survey activities within the department. Assists in developing various compensation programs within an organization. Retirement Programs Knowledge of features, policies and processes of retirement programs; ability to implement and manage employee retirement programs and plans. Level Working Knowledge: Assists employees and retirees with enrollments or changes to plan selections. Diagnoses routine problems regarding an account or options. Resolves transactional issues with retirement benefits providers. Analyzes documentation and administration requirements. Administrates organizational retirement benefits programs. What you will get: Work Life Harmony Earned and medical leave. Relocation assistance if appropriate Holistic Development Personal and professional development through Caterpillar s employee resource groups across the globe Career developments opportunities with global prospects Health and Wellness Medical coverage -Medical, life and personal accident coverage Employee mental wellness assistance program Financial Wellness Employee investment plan Pay for performance -Annual incentive Bonus plan. Additional Information: Caterpillar is not currently hiring individuals for this position who now or in the future require sponsorship for employment visa status; however, as a global company, Caterpillar offers many job opportunities outside of the U.S. which can be found through our employment website at www.caterpillar.com/careers Caterpillar is an Equal Opportunity Employer (EEO) EEO/AA Employer. All qualified individuals, including minorities, females, veterans and individuals with disabilities - are encouraged to apply. Posting Dates: April 18, 2025 - May 1, 2025 Caterpillar is an Equal Opportunity Employer (EEO). Not ready to applyJoin our Talent Community .

Job Title Manager Department Delivery Quality Job Summary As a Manager or Senior Manager - Delivery Quality , you will lead a team focused on ensuring the highest standards of quality across all deliverables and processes related to the product or service delivery. You will collaborate with cross-functional teams, monitor project health, implement continuous improvement initiatives, and ensure that all customer requirements and expectations are met or exceeded in every delivery. Key Responsibilities Quality Management Ensure that all delivery processes are aligned with organizational standards and customer expectations. Monitor and assess the quality of products and services at every stage of delivery. Process Optimization Identify, recommend, and implement process improvements to enhance delivery performance, reduce defects, and increase overall efficiency. Team Leadership Manage and mentor a team of quality assurance professionals, fostering a culture of accountability, performance, and continuous learning. Cross-Functional Collaboration Work closely with project managers, delivery teams, and other stakeholders to ensure the integration of quality measures throughout the project lifecycle. Risk Management Identify and mitigate risks that could impact the quality of deliverables, ensuring that issues are resolved proactively. Reporting & Analytics Develop and maintain key performance indicators (KPIs) to track and report on quality-related metrics. Prepare reports for leadership to highlight progress and areas for improvement. Customer Satisfaction Ensure that the delivery meets customer expectations and aligns with agreed-upon quality criteria. Handle customer feedback and ensure appropriate corrective actions are taken. Training & Development Provide coaching and training to team members and other relevant stakeholders to build quality awareness across the organization. Audit & Compliance Conduct regular audits of deliverables and ensure compliance with industry standards, certifications, and regulatory requirements. Qualifications Education Bachelor s degree or Master s degree. Certifications like Six Sigma, Lean, etc are a plus. Experience 10 to 15 years of experience in quality management, project delivery, or a similar role, with at least 5 to 8 years in a managerial position. Experience in US healthcare RCM is a must Skills Strong knowledge of delivery management and quality assurance methodologies. Proficient in process improvement tools and techniques (e.g., Six Sigma, Lean). Experience working with cross-functional teams and managing multiple stakeholders. Excellent communication and interpersonal skills. Data-driven approach to decision-making and problem-solving. Ability to analyze and interpret complex data sets to drive improvements. Certifications Six Sigma, Lean, PMP, or other relevant quality or project management certifications are highly desirable. Multi-specialty Domain Desirable Attributes Strong leadership capabilities, with the ability to inspire, mentor, and develop teams. A proactive approach to problem-solving, with a keen eye for detail. Strong customer focus with a commitment to delivering high-quality results on time and within scope. Ability to manage change and navigate complex situations with a positive and adaptable mindset.

Meet all Client Service Level Agreements (deliverables) Ensure the team understands client specific training requirements / needs etc. Analyse performance results of the team and implement process improvements. Determine appropriate staff levels and implement strategies to ensure efficient operations. Work with support departments to ensure staffing strategies are effectively executed. Hold team meetings on a regular basis with direct reports. Communicate all process and client updates to direct reports within specific timelines and keep record for such updates. Act as single point contact for the Team Leaders for all their client and team members related needs and create a harmonious work environment. Responsible for day-to-day functional supervision of each team, including productivity of the team, quality %, track absenteeism of the team and encourage team manager s to complete performance appraisal of work group(s) in accordance with the organization s policies and applicable legal requirements. Job Specification Minimum of 8 Years of Professional and Relevant Experience in Medical Coding with specialty Surgery and EM. Must have experience in Client and Stakeholder and Quality Management. Excellent experience in Team and People Management as well. Must have Coding Certification like CPC/ CCS/ COC/ AHIMA + Quality Any graduate will do. Shift Details General Shift / Day Shift Work Mode WFO

Job Title Manager Corporate Quality Job Summary The Corporate Quality Manager will work closely with the relevant stakeholders to drive Process Excellence Initiatives. This role will drive continuous improvement, risk management, and customer satisfaction. Key Responsibilities Continuous Improvement Drive continuous improvement initiatives, including Lean, Six Sigma, or other methodologies to achieve efficiency improvements, customer value creation and delivery excellence Customer SatisfactionMonitor and analyze customer feedback, ensuring effective resolution of quality-related issues. Quality Metrics and ReportingDevelop and track quality metrics, providing regular reports to senior management. Collaborate with internal stakeholders and clients to drive and influence improvement objectives. Provide support and guidance to develop and design documents including training manuals, process outlines, flowcharts, checklists, templates, and implementation procedures. Mentor and support candidates pursuing Six Sigma Yellow Belt certifications. Hands on work on project implementation, including project plan creation, governance, stakeholder management, toll gate reviews and benefit quantification Quality Management SystemsAdhere to quality management systems, including ISO 9001, ISO 27001, or other relevant standards. EducationAny Bachelor's or Master s degree ExperienceMinimum 12 to 15 years of experience in the field of Process Excellence, with at least 5 years in a managerial role CertificationsSix Sigma Green Belt, Certified Lean Practioner or other relevant certifications. Data Analysis Skills: Proficiency in data analysis tools (e.g., Excel, Tableau). Nice to Have Industry ExperienceExperience in US healthcare will be an added advantage (preferred Healthcare (RCM) experience, insurance collection business, F&A Order to Cash)

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

The Platform Engineering team is responsible for developing platforms and tools to enable DevOps and Quality Engineering at MSCI. As part of the Quality Center of Excellence, we'develop productivity related tools, services and platforms such as the MSCI software catalog and Internal Developer Platform, in addition to managing and maintaining third-party developer workflow tools. The Platform Engineering team also leads the development of the Quality Management System, which gathers and synthesizes metrics from internal and external systems to comprehensively measure and enhance Quality at MSCI. As a backend software engineer, your responsibility will be to design, develop, test, maintain, and support resilient, production-grade enterprise services, platforms, and tools. Your Key Responsibilities Manage all aspects of the Developer Workflow (SDLC) from requirements through design, development, testing, deployment, and production support. Design and integrate REST and GraphQL APIs for seamless data flow. Develop and maintain codebases using Java Spring. Utilize Git for source code management. Implement DevOps best practices and CI/CD processes. Actively participate in Agile/Scrum teams and contribute to bi-weekly sprints.

Job Information Job Opening ID ZR_2224_JOB Date Opened 20/04/2024 Industry Technology Job Type Work Experience 10-12 years Job Title Quality Manager City Coimbatore Province Tamil Nadu Country India Postal Code 638103 Number of Positions 4 RoleQuality Check Manager (QCM & HSE) Minimum of 10 years experience. Knowledge of Testing of Sand, concrete, Slabs, Steel, Cements etc. for all relevant parameters. Good interpersonal skills in Project management. Proficiency in Tamil and English Language check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#2B39C2;border-color:#2B39C2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered=""> I'm interested

Aspire Systems is currently seeking Process Assurance specialist with expertise in handling ISO audits for QMS and ISMS. Work Location : Chennai What we expect: Minimum 6 years of experience in Process Assurance role within the IT Services Industry. Hands on experience in QMS ISO 9001, ISO27001 standards, SOC 2 audit and CMMI framework Knowledge in Data privacy and related standards. Working experience in handling ISO audit internally and with external audit partners. Roles & Responsibiities: Responsible for Process definition, Implementation and maintenance of : QMS , ISMS and Privacy standards Audit Development of Metrics Periodical Reviews Responsible for process implementation within the Service Line for the accounts / projects assigned Conduct audits / facilitation and report Risks and issues at account/project level Facilitate Project status reviews Identify and report Engagement specific risks, facilitate engagement team to mitigate the risks, within the BU. Responsible for Consolidation of defects and conduct defect analysis. Perform root cause analysis on repeated Issues, NCs, etc. also responsible for best practice harvesting and adoption based on the reports sent by the QA team/Delivery team . Perform SOW reviews and provide suggestion regarding the appropriate life cyle to be selected, Metrics to be defined and follow the client demands. Provide RFP support pertaining to the information security, Privacy and QMS process. To manage the QA team and provide necessary guidance and support . Coordinate with various stakeholders and to enhance the process and tools. Define engagement specific process for relevant accounts. To communicate effectively in every situation with different stake holders like vendors, team members, manager etc. Develop Training materials and conduct / arrange for the BU level process / tools training for delivery Responsible for managing and mentoring the QA team Support the QA activities o Handle high end facilitations o Mentor the QA team Interface with external agencies / trainers, etc. Amend the process based on the organization change as and when required Prepare KT plan for new joinees in QA team and induct them in the job. Ensure complete security of company confidential information.

1. Operations Undertake co-ordination with field people from CCR for smooth operation of the plant Measure various process parameters along with Shift In-charge. Record process parameters and plant log for the respective section, inspect specific parameters on regular basis, and perform any extra duties assigned by the Shift In-Charge Monitor the quality of the products- Raw meal, Clinker and Cement- and maintain the quality within the range as defined in the QMS procedures Keep good co-ordination with the laboratory for the feedback of quality follow the non-conformity procedure in case the product is not conforming to the standards Executes, according to the safety procedures, the necessary precautions and lock-outs. Take readings of plant parameters (tour log), energy and gas, and perform basic chemical water analysis; perform periodic functional tests on plant systems Perform administrative work related to data reporting and operating procedures Check the plant regularly, reports malfunctions to the shift supervisor and makes work request Perform shift turnovers and assures the transfer of the necessary information Make suggestions for plant and operating procedure improvements Supervise the loading and unloading of chemicals to and from the trucks Responsible for the cleanliness and tidiness of the control room and other rooms used by operations Follow up the availability of operational consumables and reports deviation as needed Take initiatives to drive growth for DCBL and ensure sustained growth in line with long-term and short-term objectives of the organization Ensure initiation and sensitization of the employees towards digitization and automation of the processes Focus on utilization of advanced business analytics tools to derive key insights critical for the success of the organization 2 Environmental and Health Safety Considerations Responsible for performing the operational activities to meet standards of public safety, employee safety and environmental citizenship that meet or exceed regulatory requirements Responsible for the implementation of the work permit system and suggests improvements to the Safety Head Report dangerous hazards on plant systems, work place, working environment and general public Ensure that the plant does not violate any of the environmental rules and report problems 3. Self/ Team Development Review and monitor performance of team members and provide requisite developmental support/ inputs Complete the IDP Execution for self and team members as part of self and subordinate development Recommend training as required for teams development Develop the team and update their knowledge base to cater the organization need Strategize avenues for enhancing employee satisfaction in the function, resulting in high engagement levels of employees

Job Responsibilities: 1. To ensure continuous improvement in achievement of productivity, manufacturing yields & quality norms; Launch of new products 100% in time. 2. Quality: Demonstrate compliance to established Manufacturing Operations and Quality Standards. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. 3. Strive for reduction in Out of Specification, Deviations, reduce Market complaints. 4. Document Integrity: To support compliance of practices to established procedures and Good Manufacturing Practice standards. 5. To approve the SOPs & format, batch records relating to production operations and to ensure their strict implementation. 6. Cost: Overhead recovery, and manufacturing efficiency to be maintained. 7. Cascading Sun Values and culture to the root level. 8. People Development: Develop Talent pipelines for level II, III & IV key jobs. 9. Monitoring and control of the manufacturing environment; Process validation and calibration of analytical apparatus; Designation and monitoring of storage conditions for materials and products; compliance with GMP requirements. 10. To ensure the qualification and maintenance of department, premises and equipment. To ensure that the appropriate validations are done. 12. Retention of records; Performance and evaluation of in-process controls; 13. Training, including the application and principles of QA; 14. To design and implement the policies, systems and procedures as required for the efficient management of the shop floor.

The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements. Responsibilities: Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities. Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs. Train and educate key functional partners and management on combination product requirements, standards and regulations Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories. Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging. Provide independent design review for other programs Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection NOTE: This role may require working in shifts or extended hours within the same shift What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 4 to 6 years of Quality experience OR Bachelors degree and 6 to 8 years of Quality experience OR Diploma and 10 to 12 years of Quality experience Preferred Qualifications: 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus) Bachelors Degree in a Science Field Ability to oversee multiple medium complexity projects simultaneously Working knowledge of quality engineering and/or mechanical engineering Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211) Prior experience working as part of a combination product launch team Able to successfully manage workload to meet timelines Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving decision making by using Decision, Advice and Inform (DAI) principles Understanding of industry requirements/expectations of a Quality Management System (QMS) Understanding of the applicable manufacturing/testing processes (i.e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations Comfortable with both drug and device terminology Ability to travel +/- 15-20% of time to domestic and international Amgen sites.