Bengaluru
INR 5.0 - 8.0 Lacs P.A.
Work from Office
Full Time
This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site lead, the Quality Control Analyst is responsible for managing the day today activities quality control function at Cepheid India Private Ltd. Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements. In this role, you will have the opportunity to: Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs). Competent technical staff for supervision the Testing/ analysis of diagnostic reagents kits. Perform inspections of incoming, in-process and finished products. Performs and calibration and maintenance of lab equipment as per requirements. May perform special projects on analytical and instrument problem solving. Ensure that lab cleanliness and safety standards are maintained. Qualify test methods as part of new product development activities. Serve as a technical liaison between quality control and other departments Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses Write or revise standard quality control operating procedures. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines. Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Review records and documents for completeness and compliance with company policies and procedures. Support for internal audit schedule, NC, CAPA for site. Review production batch records, QC test results and release product. Education and Experience: masters degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years experience with in Vitro Diagnostics (IVD) is mandate Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable Quality competent technical person approved as per DC act if any Knowledge and skills: Hands on Experience on IVD product testing. Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS. Must be flexible to work off-shifts and weekends as per production Schedule. Schedule orientated (able to consistently maintains schedules and meet timelines) Strong interpersonal skills, Effective organization and Communication skills are essential. Good skills in English language Knowledge of Microsoft Word and Excel Strong multi-tasking and attention to details skills. It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Able to interpret quality problem and establish practical solutions within a dynamic business environment. Experience in leading continuous improvement efforts, in both quality systems and products. Knowledge of the process of establishing facility QMS certifications. Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable.
Gurugram
INR 4.0 - 7.0 Lacs P.A.
Work from Office
Full Time
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. The Customer Technical Support & Service Coordination Specialist is responsible for providing remote product support to customers requiring assistance with instrumentation, LIS, software, hardware components and Assays sold and distributed by Cepheid. As a member of the Technical Support Team, you provide product support to internal and external customers and provide a solution to the issues faced by Customer. This is done majorly remotely via phone, email and web serving as the technical expert in Cepheid s Customer Care experience and log and maintain all customer queries/complaints in CRM. This role will also be responsible for supporting the coordination activities to facilitate on-site intervention by Field Service Engineer. This position is part of the APAC Customer Care Team and will be located in Gurugram, India . In this role, you will have the opportunity to: Engage customers to collect and compile detailed information about customer complaints. Conduct data analysis and basic troubleshooting for instrument, hardware, assays, software, and operating system. Investigate and resolve first level customer complaints remotely through phone and email. Document complaints and resulting investigations in the Complaint Management System (SFDC). Adhere to Quality Management System procedures. Complete all assigned and required training satisfactorily and on time and keep the records data for any future audit(s). Complete all compliance and internal training within the stipulated timeline. Train internal associates and new hires on the technical support modules and CRM. Represent Technical Support on projects and operational teams, communicating findings back to Technical Support. Performs additional tasks as assigned by the Technical Support Manager or Supervisor. Coordinating with customers for all service-related activities (Contracts renewal, Engineer visit, Spare parts transfer, Defective parts return). Dispatch Field Service Engineers for service calls as appropriate and actively communicate with the FSE to confirm all logistics to ensure proper recording and communications. Process purchase orders for billable service activities, which relate to service calls and preventative maintenance events. Bachelor s degree in engineering / electronics or experience working in Biological / Clinical Laboratory Science / Life Science / Medical Device Industry with minimum 5+ years of relevant experience (or equivalent), preferably in a fast-paced Customer Support & Service, Order Management role. Master s Degree with minimum 3+ Years of related work experience.). Fluent English (written and oral). Laboratory or Remote Technical Support Experience in one or more of the following is a plus: PCR and Microbiology, Molecular Biology Oncology or Virology, Patient sample collection practices and workflow, Sample preparation practices and methodologies, Laboratory analytical diagnostic equipment, medical devices, and software. Customer oriented - understands customer expectations and empathizes with customer & patient needs. Knowledge and use of commercial computer application packages (MS Excel), Familiarity with SalesForce.com (or similar CRM System) and SAP a plus. Able to follow complex procedures and processes. Works independently in a structured manner with the ability to prioritize critical tasks. Builds collaborative work relationships with different teams, including Field Service, Field Application, Sales, Marketing and Quality. Thrives in a dynamic and fast-paced environment. May include extended computer and telephone work involving repetitive arm/wrist motions. Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com . When you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we ll empower you to push the boundaries of what s possible. If you ve ever wondered what s within you, there s no better time to find out. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Bengaluru
INR 7.0 - 11.0 Lacs P.A.
Work from Office
Full Time
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. We are looking for a Plant Finance Analyst to serve as the primary FP&A Resource to the Factory Finance team and will be accountable for the financial results of the manufacturing operations of this business. This role entails Financial reporting of costs, variance analysis, budgeting, Monthly forecasting and ensuring that all cross-functional are incorporated. Role - Ensure Standard Cost is set up correctly and actively involved in the stand cost roll. Estimating the Standard cost for business cases Review of Open orders Analysis WIP closure. Perform Variance Analysis. Identifying and communicating actionable steps to address variance of PPV & MUV. Analysis of Over/under absorption indicating the root cause. Estimating the Labor Hour Rate and Overhead absorption rate based on Budget v/s Actual. Review of Scrap Process and ensure correct accounting of scrap monthly. Prepare and ensure the Budget is submitted in timely manner. Monthly review and management reporting. very good understanding and hands on SAP Inventory Analysis - FIFO Compliance, Expiry & obsolesce of Inventory. Fixed Assets & CIP Review Develop and provide ad-hoc reports as required by the management. Ensure compliance with policies and procedures of the Company. Improve processes and enhance controls. Ensuring month-end close as per timelines . Cross functional co-ordination. . Support during Audits Maintaining / Supporting US GAAP and IGAAP books of accounts. Support in Statutory Audit Independently handling Cost Audit Filing of ASI returns with NSSO. Qualifications : ICWA or similar field required 3 + years of experience in Manufacturing Set up. Experience in SAP is must. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Gurugram
INR 40.0 - 45.0 Lacs P.A.
Work from Office
Full Time
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. Business Support: Be the lead business/finance partner to the General Manager- South Asia. Own the South Asia Commercial and HBDC forecast by month and by product line working with business owners to formulate the forecast for both revenue and margin. - Emphasis placed on monthly and quarterly forecast accuracy - Emphasis placed on core sales growth on a YoY basis - Emphasis is placed on the profitability of the business in line with the overall Cepheid average Provide high integrity advice and expertise for complex commercial transactions ensuring growth and profitability while maintaining compliance to laws and regulations. Partner with country Finance and business leaders to drive improved results in Working capital (Accounts Receivables, Inventory and Accounts Payable). Use the Danaher Balance Sheet wisely for the Growth of the businesses where it makes sense Own responsible Accounts Receivable and Inventory levels for the business that balance delivery vs carrying cost particularly given shelf-life issues in the business. Other ad-hoc duties as assigned by the Cepheid CFO. Support the manufacturing operations including capital projection, expansion, costing and production commencement Compliance and Control Duties: Maintain and enhance our system of Internal Controls by working directly with country Finance and business leadership keeping up to date with current trends and liaising with both Group and Danaher Corporate personnel to follow the new guidance. Maintain a high-integrity team in pursuit of excellent internal controls. Be the key contact to Legal and Compliance functions to ensure that all required compliance actions and steps are enacted into practice/process as would specifically relate to the APAC finance and accounting teams. Work directly with Regional OPCO Finance leaders to ensure that teams and processes ensure the timely and accurate closing and preparation of financial information in accordance with US GAAP and Danaher reporting requirements. Working with these teams, ensure that all local statutory reporting requirements are met timely and accurately. These local requirements might include local sales and use tax activity, VAT activity and filing of locally audited financial statements as appropriate. Drive organization improvements to develop the best team possible and work with staff to ensure that adequate development plans are in place so that we create and grow a bench of high-integrity talented accountants and business partners. Working with the Director of Technical and Revenue Accounting, make sure that all unique transactions have full transparency for revenue recognition and/or proper accounting/recording. Oversight of tax compliance in India tax jurisdiction where Cepheid has PE; interface with DHR tax dept.; ensure transfer pricing policy and agreements are in place and compliant Oversight of inter-company commerce between Cepheid operational sites and the resulting impact on taxable income Key Business Relationships: South Asia leadership team and APAC regional finance and business leaders & Danaher Internal Audit Danaher Corporate Finance External Auditors Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Bengaluru
INR 14.0 - 19.0 Lacs P.A.
Work from Office
Full Time
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. Cepheid is looking for a Lead Product Security Engineer responsible for the end-to-end security of Cepheid product(s) and working closely with software engineering and product security council in achieving product and security objectives. We are looking for passionate security professional with experience of working with software/application development, in a regulated industry supporting the implementation of secure development practices, threat modeling, architecture, design, vulnerability assessment and security verification/validation. This position is for Cepheid team located at Danaher India Development Center (IDC), Bangalore IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 500+ associates, for multiple Danaher operating companies. The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, and Oncology, IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly skilled software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists. The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility, measuring 120 K Sqft. In this role, you will have the opportunity to: Serve as a technical leader and mentor other product security engineers Develop/contribute success criteria for security product/solution testing Lead/contribute to vulnerability/incident assessment as per our defined process Address vulnerabilities and maintain product security posture The essential requirements of the job include: Engineering degree in Computer Science or equivalent 8+ Years of Relevant Experience Execute and Manage penetration testing, SAST, vulnerabilities assessment, threat modeling, security risk assessment across Cepheids products. Build cybersecurity controls, assess existing security controls, review security architecture and build security requirements and roadmaps for Cepheid systems. Knowledgeable in key aspects of the hardware; software, protocols, cloud and related infrastructure technology stack. Build product security capabilities, tools, and help automate where possible driving improvements to Cepheid product security processes and practices It would be a plus if you also possess previous experience in: Specialization in Cybersecurity preferred Industry experience in a regulatory environment. Working knowledge in Cybersecurity with software/application or product development. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. Were innovative, fast-paced, results-oriented, and we win. We need skilled people to keep winning. Here youll learn how DBS is used to shape strategy, focus execution, align our people, and bring value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. Equal Opportunity Employer Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Bengaluru
INR 5.0 - 8.0 Lacs P.A.
Work from Office
Full Time
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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