682 Change Control Jobs - Page 25

Role Description Overview: Coder is accountable to manage day to day activities of coding the Patients chart & Diagnosis report. Responsibility Areas: Coding or auditing charts, based on requirements Updating/Clearing the production/pending reports To work closely with the team leader. To review emails for any updates Identify issues and escalate the same to the immediate supervisor Strict adherence to the company policies and procedures. Sound knowledge in Medical Coding concept. Should have 6 months to 3 Yrs of Coding Experience. Understand the client requirements and specifications of the project. Meet the productivity targets of clients within the stipulated time (Daily & Monthly) Applying the instructions/updates received from the client during production. Coding or auditing charts, based on requirements. Prepare and Maintain reports

Role Description Overview: Coder is accountable to manage day to day activities of coding the Patients chart & Diagnosis report. Responsibility Areas: Coding or auditing charts, based on requirements Updating/Clearing the production/pending reports To work closely with the team leader. To review emails for any updates Identify issues and escalate the same to the immediate supervisor Strict adherence to the company policies and procedures. Sound knowledge in Medical Coding concept. Should have 6 months to 3 Yrs of Coding Experience. Understand the client requirements and specifications of the project. Meet the productivity targets of clients within the stipulated time (Daily & Monthly) Applying the instructions/updates received from the client during production. Coding or auditing charts, based on requirements. Prepare and Maintain reports

Job Information Job Opening ID ZR_1962_JOB Date Opened 17/05/2023 Industry Technology Job Type Work Experience 6-10 years Job Title Duckcreek Billing Business Analyst City Hyderabad Province Telangana Country India Postal Code 500081 Number of Positions 5 6-10 years of Duck creek Billing Business Analyst. Excellent P&C Commercial Insurance Lines of business knowledge and work experience, Min 6 years of Duck Creek Billing platform work experience and should have worked on end-to-end on both Direct and Agency billing implementation projects for US insurance company. Sound knowledge in billing system workflow and in different integrations (internal and 3rd party) Good experience needed in requirements gathering, conducting client workshops and collaborating with multiple stakeholders, Ability to understand client requirements, perform business analysis Develop, analyze and document requirements, including business, functional and non-functional Excellent written and verbal communications Location: Pune, Mumbai, Chennai, Bangalore, Hyderabad 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

Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com

Job Title: Management Associate MPD – AMA Contract Resource Department: MPD-BB, AMA PHC Location: Andheri East Chakala, Mumbai Position Type: Full-Time, Contractual Vacancies: 1 Job Description: We are seeking a Management Associate to support the MPD – AMA team on a contractual basis. This role involves key responsibilities in pharmaceutical documentation, data management, and coordination to ensure efficient support to formulation and analytical development teams. Key Responsibilities: Setup of Enovia DSM for formulation parts and documentation. Compilation and tracking of stability study data for review and approval in Enovia. Raise and manage Change Controls in Veeva QA system for MPD department (CCPs in scope). Maintain status trackers for ongoing/pending CCPs and ensure timely closure and action item follow-ups. Support the MPD Process and Analytical teams with preparation of batch records and other regulatory documentation. Create Coupa Purchase Orders (POs) based on verified quotations. Perform QC Soft entries for reports on stability data, raw material samples, and protocol documentation. Coordinate with the MPD lab team for: Disposal of laboratory waste. Dispatching samples for external testing with accurate documentation. Updating records for destruction of leftover stability samples. Assist in TT document and supplier qualification reviews . Liaise with RM suppliers for collection and review of material qualification and safety documents . Perform additional tasks as assigned by the MPD team. Qualifications: B. Pharm / M. Pharm from a recognized institution. Experience: Minimum 2 years of relevant experience in Formulation Development (F&D) and Technology Transfer functions in a reputed pharmaceutical company. Key Skills: Familiarity with Veeva QA, Enovia DSM, QC Soft, and Coupa Strong knowledge of pharmaceutical documentation and stability study processes Experience in Change Control and Regulatory Compliance Good communication and coordination skills Proficient with MS Teams, SharePoint, and Email correspondence

Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; . Strong understanding of Good Manufacturing Practices (cGMP), Current Good Laboratory Practice (cGLP), and International Organization for Standardization (ISO). Proficiency in handling chemicals safely according to OSHA regulations.

What you will do Let's do this. Let's change the world. In this vital role you will be responsible for leading and charting the course for the Digital Quality Management System (DQMS) product team that builds and transforms technology capabilities that positively impacts business outcomes. Specifically, this individual will be responsible for planning, design, configuration, deployment, and support of Veeva Digital QMS solution. The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead a team responsible for the ongoing management, optimization, and innovation of Amgen's Digital QMS platform Lead technical teams to design system configurations, data mappings, and integrations between Veeva platforms and other quality systems Ensuring data integrity by defining data quality standards, monitoring data quality issues, and working with data stewards to address discrepancies Supporting the validation processes defined by Amgen for the Veeva QMS, ensuring compliance with regulatory standards (e.g., FDA, GxP) throughout the implementation and ongoing usage Responsible for leading, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage large, diverse teams within a matrixed organization Collaborate with geographically dispersed teams, including those in the US and other international locations Lead all aspects of the software development lifecycle Develop and implement strategic plans for technology and workforce Develop a culture of collaboration, innovation, and continuous improvement Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree and 2 years of experience in Business, Engineering, IT or related field OR Master's degree with 810 years of experience in Business, Engineering, IT or related field OR Bachelor's degree with 1014 years of experience in Business, Engineering, IT or related field OR Diploma with 1418 years of experience in Business, Engineering, IT or related field Solid understanding of QMS processes, including Deviation, Change Control, SQM & Audit & Inspections Expertise in Veeva QMS functionalities, including configuration, reporting, and workflow management Demonstrated experience in leading technology initiatives and teams with a track record of successful innovation Exceptional collaboration, communication and interpersonal skills to effectively manage partner relationships and build new partnerships Experience in applying technology best practice methodologies Scaled Agile (SAFe), ITIL, etc. Preferred Qualifications: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle with technology used in a GxP environment Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Scaled Agile Framework (SAFe) for Teams required Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams

What you will do Let's do this. Let's change the world. In this vital role you will be responsible for leading and charting the course for the Digital Quality Management System (DQMS) product team that builds and transforms technology capabilities that positively impacts business outcomes. Specifically, this individual will be responsible for planning, design, configuration, deployment, and support of Veeva Digital QMS solution. The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead a team responsible for the ongoing management, optimization, and innovation of Amgen's Digital QMS platform Lead technical teams to design system configurations, data mappings, and integrations between Veeva platforms and other quality systems Ensuring data integrity by defining data quality standards, monitoring data quality issues, and working with data stewards to address discrepancies Supporting the validation processes defined by Amgen for the Veeva QMS, ensuring compliance with regulatory standards (e.g., FDA, GxP) throughout the implementation and ongoing usage Responsible for leading, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage large, diverse teams within a matrixed organization Collaborate with geographically dispersed teams, including those in the US and other international locations Lead all aspects of the software development lifecycle Develop and implement strategic plans for technology and workforce Develop a culture of collaboration, innovation, and continuous improvement Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree and 2 years of experience in Business, Engineering, IT or related field OR Master's degree with 810 years of experience in Business, Engineering, IT or related field OR Bachelor's degree with 1014 years of experience in Business, Engineering, IT or related field OR Diploma with 1418 years of experience in Business, Engineering, IT or related field Solid understanding of QMS processes, including Deviation, Change Control, SQM & Audit & Inspections Expertise in Veeva QMS functionalities, including configuration, reporting, and workflow management Demonstrated experience in leading technology initiatives and teams with a track record of successful innovation Exceptional collaboration, communication and interpersonal skills to effectively manage partner relationships and build new partnerships Experience in applying technology best practice methodologies Scaled Agile (SAFe), ITIL, etc. Preferred Qualifications: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle with technology used in a GxP environment Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Scaled Agile Framework (SAFe) for Teams required Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams

Glowria Lifecare Pvt. Ltd. is looking for QA Officer to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control processes and procedures.Conduct audits of production processes and facilities to ensure compliance with regulations and quality standards.Develop and maintain documentation related to quality control activities.Investigate and resolve quality issues, working closely with production, engineering, and other departments.Develop and maintain product or service specifications, quality plans, and procedures.Monitor and analyze quality data to identify trends and opportunities for improvement.Train employees on quality control processes and procedures.Collaborate with suppliers and customers to ensure quality requirements are met.Manage and report on quality control metrics.Ensure compliance with all regulatory requirements and standards.Knowledge of quality control principles, practices, and procedures.Strong analytical and problem-solving skills.Excellent communication and interpersonal skills.

Welspun India Ltd is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey. Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

MetLife is looking for Software Dev Engineer Test II to join our dynamic team and embark on a rewarding career journey. Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Reviewing existing products or concepts to ensure compliance with industry standards, regulations, and company policies Preparing proposals for new projects, identifying potential problems, and proposing solutions Estimating costs and scheduling requirements for projects and evaluating results

Job description Should have sound knowledge of QMS System and Change Control, Deviation and CAPA Procedure. Review of Preventive maintenance & calibration of equipment and systems. Investigation and closure of all deviations, OOS and complaints

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Validation Engineer What you will do 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. In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarilysynthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will includetech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. 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.

Specialist Quality Assurance - Global Supply Quality What you will do Let’s do this. Let’s change the world. In this vital role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with suppliers of raw materials and devices. 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 external suppliers and contract manufacturers. Roles & Responsibilities: Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type. Documentation review and approval includingsupplier records, investigation reports, Amgen quality records, and validation records. Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles Oversight and completion of supplier assessments and documentation to support product complaints. Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Review and approval of change control records for supplier changes. Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence. 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. Develop solutions that are thorough, practical, and consistent with functional objectives This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree with 4+ of experience in quality management systems or a related field OR Bachelor’s degree with 6+ years of experience in quality management systems or a related field OR Diploma with 8+ years of experience in quality management systems or a related field. Preferred Qualifications: Must-Have Skills: Minimum of 2 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Good-to-Have Skills: Experience in creating digital solutions and working within computerized systems 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 and regulatory requirements (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, and combination products). Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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.

What you will do Let’s do this. Let’s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation. Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance 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 Quality experience OR Bachelor’s degree and 3 to 5 years of Quality experience OR Diploma and 7 to 9 years of Quality experience Preferred Qualifications: Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry Bachelor’s Degree in a Science Field Ability to successfully manage workload to timelines Familiarity with basic project management tools Ability to operate in a matrixed or team environment with site, functional, and senior management leadership Experience in driving decision making by using the DAI principles Understanding of quality and industry requirements/expectations of a QMS Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format 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.

Jubilant Foodworks Limited is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Jubilant Foodworks Limited is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Jubilant Foodworks Limited is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Jubilant Foodworks Limited is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

This role is responsible for leading a project team in delivering a solution to the client using the appropriate business measurements and terms and conditions for the project according to the project charter, project agreement or contract. They have overall performance responsibility for managing scope, cost, schedule, and contractual deliverables, which includes applying techniques for planning, tracking, change control, and risk management. They are responsible for managing all project resources, including subcontractors, and for establishing an effective communication plan with the project team and the client. They provide day to day direction to the project team and regular project status updates and requests for support to project stakeholders Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise SAP Implementation and ConfigurationA strong understanding of SAP modules and components, including SAP ERP, CRM, SCM, BW/BI, etc. Ability to lead and oversee SAP support projects. Project ManagementExperience in managing SAP projects, including planning, scheduling and resource management. Knowledge of project management methodologies such as Agile or Waterfall. Team Leadership and ManagementAbility to lead a team of SAP professionals, providing guidance, mentoring, and support. Experience in building and managing high-performing teams. Business Process KnowledgeIn-depth understanding of business processes of electronics industries and how SAP solutions can be tailored to meet business requirements. Integration Skills: Understanding of how SAP systems integrate with other third-party systems and applications. Experience with middleware solutions like SAP PI/PO Preferred technical and professional experience Client ManagementExperience in managing relationships with client and partners. Negotiation skills for contracts and service level agreements. SAP CertificationsCertifications such as SAP Certified Application Associate or Professional can demonstrate a deep understanding of specific SAP modules. Analytics and ReportingFamiliarity with various reporting tools for management of project and understanding of project financials

To Maintain the machine and work place clean in all respect. Carry out all activities in area with required status labelling procedure as per SOP. To maintain overall cGMP and GDP in department. To impart training and evaluation of company employees. Preparation of SOP, BPR and Validation Protocol. Handling of deviation, incident, change control and CAPA. Responsible for all activities carried out in shift. To ensure availability of secondary packing material for packing activities. Responsible to ensure dispensing, equipment cleaning, visual inspection, vial labelling, cartonator machine,online Responsible for in process Packing activities and Finished good activities as per SOP. Planning and participation in validation of equipment. Report to Department head regarding any process or operation related problem. Manpower planning and allocation of work according to their skill.

To review site responses to CAC audit foradequacy & supporting exhibits in ZyACTM. Tracking and review of regulatory/ Corporatecommitments. To organize compliance meeting, follow upmeetings / communication with site and CQ Leads to discuss unresolvedobservations or findings. To Present the progress in monthly reports forthe site (include ZyACTM Response of audit reports) and participation indepartmental meetings. To ensure SOP on Corporate Audit andCompliance is followed effectively. To participate in need based corporate auditsand compliance verification as per schedule. To support site for compliance duringpreparedness and follow up for updates compliance. assignedby management) for adequacy and appropriateness. To identify and escalate specific issue tomanagement for compliance & support. To maintain all portals updated (ZyACTM, CQACalendar, Regulatory commitment) Participation in development of new initiatives Preparation of monthly reports and participationin departmental meetings. Any other task assigned by reporting authoritytime to time for enhancement of compliance. System harmonization-Identification of need,escalation & Tracking for resolution. Travel to multiple sites as per requirement foraudit purpose. Candidate Requirements: Candidate Must have rich experience in API auditand compliances. Must have Excellent Communication, Drafting andInterpersonal skills. Must have experience of audit andcompliances of API. Must be ready to travel on multiple sites foraudit purpose.

Establish / maintain compliance with FDA QSRs (GMP) Working with Production teams to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing. Export compliance system, Compliance of labeling, quality control and a quality system for excipients Documentation Control Process and Documentation Change Control Process Good Documentation Good Communication

Handling of Laboratory Incidents, Change Control, Deviations OOS & OOT Handling of CAPA, Coordinate with technical team for timely closure of QMS documents. Writing SOP's. Support Internal & External Audit Finding Responses.