883 Lims Jobs - Page 31

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Education/Experience (BMQ): Masters degree in a science-related field (Biochemistry / Biotechnology / Microbiology) with 3-7 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements.Experience with analytical techniques such as qPCR, microbiological techniques, knowledge of USP/EP/JP compendia, and laboratory software applications such as PCR analysis software, bioinformatics tools, and LIMS is preferred Additional Information Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience Strong Math Skills Logical Thinking, Good Reasoning Ability Motivation to excel Coaching/mentoring of peers

Business/Functional Analyst Department: Information Technology Critical features of this job are described under the headings below. They may be subject to change at any time due to reasonable accommodation or other reasons. Job Summary As a Business/Functional Analyst at Eurofins Environment Testing US you will play a pivotal role in driving business success through effective analysis, strategic planning, and solution development. Working closely with cross-functional teams, you will be responsible for identifying business needs, defining requirements, and facilitating the implementation of innovative solutions. Your primary focus will be on user story creation for transformation of an existing laboratory information management system (LIMS) to a new web-based stack. Essential Duties and Responsibilities Collaborate with IT Project Managers, Development teams, and stakeholders to identify and prioritize business requirements. Conduct thorough analysis of current business processes, systems, and workflows to identify areas for improvement. Translate business requirements into functional specifications and technical requirements for implementation. Facilitate communication and collaboration between business stakeholders and technical teams throughout the project lifecycle in conjunction with the Project Manager. Lead Scrum ceremonies for the scrum team you are working in. Participate in solution design sessions and provide input on system architecture and functionality. Perform user acceptance testing (UAT) to ensure that implemented solutions meet business requirements and quality standards. Other Duties Provide ongoing support and assistance to end-users, including troubleshooting issues and providing training as needed. Stay abreast of industry trends, best practices, and emerging technologies to drive continuous improvement and innovation. Travel as needed. Qualifications: Bachelors degree or higher in Science (Environmental, Chemistry or similar), Information Systems, Computer Science, or related field. 3+ years proven experience as a Business Analyst, preferably in a technology-driven environment. Excellent communication skills, with the ability to effectively communicate technical concepts to non-technical stakeholders. Solid understanding of project management methodologies and tools. Experience with Laboratory Information Management Systems (LIMS) is highly desirable. Familiarity with Agile methodologies and software development lifecycle (SDLC) processes is preferred. Certification in Business Analysis (e.g., CBAP, CCBA) is a plus. Supervisory Responsibilities None Working Relationships Internal contacts: Project Managers Business Analysts Developers Subject Matter Experts Laboratory Personnel LIMS Implementation Team Knowledge Environmental, Analytical and/or General Science a plus Project management software such as Jira and Teams. Knowledge of LIM systems and general IT terms and environment. Attendance Regular attendance is necessary and is essential to meet the expectations of the job functions. NOTEThis job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Additional duties may be included on an attachment.

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. The Project Manager Assistant (PMA) position is an administrative role working directly with a group of Project Managers, focusing on a specific area of the business. This role requires the use of technical functions to navigate Eurofins Lancaster Labs (ELLI) information systems, construct and develop relationships with ELLIs internal scientific and support departments, and assist project managers with a variety of tasks to allow the PMs to focus on client communication. Please note that this position does require direct client interaction. This is a great role if you also aspire to move into a PM position in the future. Employee Responsibilities: Support Sample and Project Management in building and maintaining studies including entering and review of material items, study start and end dates, and generating project plans for the PM teams. Managing incoming and in house Reference Standards by reaching out to the client for updated CoAs when expirations are approaching. Working with Pricing and Analytical Definition to generate quotes and build templates for sample entry of incoming samples. Track financial aspects of projects including purchase order and invoice management. This may also include generating Change Orders, special invoice requests and potentially End of Month billing for clients that qualify. Support Project Managers in an administrative capacity with a variety of other assignments Qualifications M. Pharm / M.Sc, Analyitical Chemistry PMP certification would be an additional advantage Additional Information Experience Level : 5 - 7 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Possesses excellent communication skills both oral and written Has a strong organization and attention to detail Computer skills Experience utilizing MS Office and MS Project or other project organization tools. Experience navigating a LIMS or equivalent is a plus Ability to learn new techniques, perform and prioritize multiple tasks simultaneously, keep accurate records, follow instructions, and comply with agency and company policies (GMP knowledge is a plus) Ability to work both independently and as part of a team, be self-motivated, adaptable, and maintain a positive attitude, even with critical deadlines Initiative/ Self-Starter proactively seek out work and training opportunities, offer to assist others, strive for high productivity and output in a fast-paced environment

Business/Functional Analyst Department: Information Technology Critical features of this job are described under the headings below. They may be subject to change at any time due to reasonable accommodation or other reasons. Job Summary As a Business/Functional Analyst at Eurofins Environment Testing US you will play a pivotal role in driving business success through effective analysis, strategic planning, and solution development. Working closely with cross-functional teams, you will be responsible for identifying business needs, defining requirements, and facilitating the implementation of innovative solutions. Your primary focus will be on user story creation for transformation of an existing laboratory information management system (LIMS) to a new web-based stack. Essential Duties and Responsibilities Collaborate with IT Project Managers, Development teams, and stakeholders to identify and prioritize business requirements. Conduct thorough analysis of current business processes, systems, and workflows to identify areas for improvement. Translate business requirements into functional specifications and technical requirements for implementation. Facilitate communication and collaboration between business stakeholders and technical teams throughout the project lifecycle in conjunction with the Project Manager. Lead Scrum ceremonies for the scrum team you are working in. Participate in solution design sessions and provide input on system architecture and functionality. Perform user acceptance testing (UAT) to ensure that implemented solutions meet business requirements and quality standards. Other Duties Provide ongoing support and assistance to end-users, including troubleshooting issues and providing training as needed. Stay abreast of industry trends, best practices, and emerging technologies to drive continuous improvement and innovation. Travel as needed. Qualifications: Bachelors degree or higher in Science (Environmental, Chemistry or similar), Information Systems, Computer Science, or related field. 3+ years proven experience as a Business Analyst, preferably in a technology-driven environment. Excellent communication skills, with the ability to effectively communicate technical concepts to non-technical stakeholders. Solid understanding of project management methodologies and tools. Experience with Laboratory Information Management Systems (LIMS) is highly desirable. Familiarity with Agile methodologies and software development lifecycle (SDLC) processes is preferred. Certification in Business Analysis (e.g., CBAP, CCBA) is a plus. Supervisory Responsibilities None Working Relationships Internal contacts: Project Managers Business Analysts Developers Subject Matter Experts Laboratory Personnel LIMS Implementation Team Knowledge Environmental, Analytical and/or General Science a plus Project management software such as Jira and Teams. Knowledge of LIM systems and general IT terms and environment. Attendance Regular attendance is necessary and is essential to meet the expectations of the job functions. NOTEThis job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Additional duties may be included on an attachment.

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Support processing of incoming samples by accurate and timely entry and review of sample information in LIMS. Employee Responsibilities: Audit sample information, including the formal review of all protocols, specifications, methods, and other documents submitted by the client or used by the project within a LIMS system. Manage technical information within a LIMS system relating to Sample Management. Send entry instructions to the sample administration regarding incoming samples. Direct client interaction via email Communicate with Project Management, Inside/Outside Business Development, and Technical groups as necessary to complete assignments Communicate regular status updates to supervisor Qualifications M.Pharm/M.Sc Additional Information Experience level : 3 - 5 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

What's the role The FPP Scheduling Advisor aids sites to deliver maximum value from margin optimization activities implementing planning and scheduling work processes, increasing staff competencies, assuring accurate representations in optimization and scheduling models (including gasoline blending). They provide deep expertise in the understanding and use of the site Scheduling Models for Refinery and Chemical site planning through the deployment of cutting-edge technology. The Advisor works in close collaboration with site E&S teams, TAS E&S team, P&T Basic Data, Scheduling, Crude and FPP Excellence Advisors. The FPP Scheduling Advisor Role is seen as critical to ensuring that the E&S community is well supported and to help maximize value generation from our sites. This role is expected to be fully accountable for the activities below. What you'll be doing MODELING Acts as primary technical expert for E&S Scheduling tool (currently Aspen’s APS/Orion), supporting site Scheduling teams. (Scheduling and Blending) Supports practitioners with urgent problem solving to ensure business continuity and escalates to central TBI Optimization Advisors or 3rd Party vendor as appropriate. Implements new advanced simulation and optimization capabilities and better representation (including visualization) of process plants in Scheduling tools. Supports in the assurance that scheduling models are lean, up to date and changes are communicated amongst Scheduling and Planning Advisors and EMC’s to ensure alignment between PIMS, Orion and MBO models. Provides support to configure all existing and new reports from the tools. Supports programming, testing, enhancements, configuration, maintenance of non-IT supported data input and Solution reports. Maintain best practice recommendations in a structured fashion and help propagate these within the E&S practitioner community for Scheduling and Blending. Support in effective backcasting activity and practices that ensures the health and fidelity of the relevant submodels, databases, data tables, model logic, stream routings, blend rules and properties, with the intent of constantly driving optimal solutions and decision making by the practitioners. TRAINING / DEVELOPMENT Supports with the onboarding of new employees with scheduling tools and all relevant FPP work processes. MARGIN OPTIMIZATION STUDIES Support with structured margin improvement interventions and ensures / assists with implementation of recommendations as relevant with Scheduling and Blending capability of sites. DATA INTERFACES Ensures validation of data flows of daily baseline data interface configurations (PI and LIMS), all movement interface configurations and all hourly plant data (PI and LIMS) into the ‘model accuracy’ graphs (configuration, troubleshooting, and display) Coordinate data interface bug fixes or enhancements with IT. INSTALLATIONS AND TROUBLESHOOTING Provides business advice to DS IT regarding Scheduling/Blending PC software installations and helps troubleshooting where needed Configure and support maintenance of Add-ons (with data tables/files) for standard and site relevant work-processes. Coordinate Add-on bug fixes or enhancements, Beta Testing and User Acceptance testing with IT. DATABASE MANAGEMENT Coordinates database table purge requirements (retention days/dates) to stay consistent with site work processes and to prevent the database size from causing failures in MDB backup creation. Corroborates with IT to ensure all SQL and MDB backup creations are complete and routine (which involves oversite/monitoring). Provides site database user account management, including user group model/event permissions configuration setup and changes. Provides maintenance, programming, and updating of the site MDB Pass-through database (including up-to-date AspenTech data queries). GENERAL E&S SUPPORT Ensures compliance with the requirements and consistent application of the FPP planning work processes in AMS and assists with the closure of recommendations. Scheduling Advisor will lead regional Scheduling networks with support from a sponsoring E&S Manager. CHALLENGES Networks will play a key role in the new organizational setup to ensure peer-to-peer collaboration and support between the various sites, as well help in ensuring best practices in the relevant areas are being pursued at all sites. The Advisor will network with their colleagues in the Europe and Americas regions to ensure inter-regional connectivity. What you bring Preferably with a University Degree in Chemical Engineering or Petroleum Engineering, with relevant refinery oil and gas experience. Preferably with at least 6 years of experience in refinery planning and scheduling space working with planning tools or Software Industry associated with developing product and tools for Refinery Planning and Scheduling space Preferably with mastery level experience in Aspen Petroleum Scheduler (APS) / Aspen Unified Scheduling (AUS) Has deep knowledge around the utilization of hydrocarbon and refinery economic value drivers Able to demonstrate commercial mindset to identify and drive margin opportunities to delivery Excellent analytical, oral and written communication skills Team player and self-motivated. What we offer You bring your skills and experience to Shell and in return you work with talented, committed people on one of the most important challenges facing our planet. You’ll have the opportunity to develop the skills you need to grow in an environment where we value honesty, integrity and respect for one another. You’ll be able to balance your priorities as you become the best version of yourself. Progress as a person as we work on the energy transition together. Continuously grow the transferable skills you need to get ahead. Work at the forefront of technology, trends and practices. Collaborate with experienced colleagues with unique expertise. Achieve your balance in a values-led culture that encourages you to be the best version of yourself. Join an organization working to become one of the most diverse and inclusive in the world. We strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation and life experiences to apply. Grow as you progress through diverse career opportunities in national and international teams. Gain access to a wide range of training and development programs. Shell in India Shell is a diversified energy company in India with 13,000 employees, and presence in Integrated Gas, Downstream, Power, Renewable and Upstream. Additionally, we have deep capabilities in R&D, digitalisation, and business operations. Our global strategy, Powering Progress, is designed to generate value for our shareholders, customers, and the wider society, and focuses on creating more value with less emissions. The strategy supports our purpose of providing more and cleaner energy solutions, with the aim of profitably transforming Shell into a net-zero emissions energy business by 2050. As India moves towards its target of net-zero emissions by 2070, Shell India aims to play a leading role in securing vital energy for today, while investing in, and helping to build, the energy system of the future through strategic investments in the country. Our Lubricants business serves over 50,000 consumers through a strong network of over 200 distributors, and operates an end-to-end value chain that spans conceptualization, development, and production at a world-class blending plant at Taloja. Through our 350-plus retail stations, we offer an integrated mobility experience including fuels, cafes, and convenience stores, with a prominent network of EV recharging facilities. Shell owns and operates a LNG re-gasification terminal at Hazira, Surat, with a capacity of 5 MTPA and a LNG truck-loading unit that plays a crucial role in helping meet India’s growing demand for gas across sectors. In 2022, Shell acquired Sprng Energy in a $1.55 billion deal to build an integrated energy transition business in the country. Sprng is a leading renewable energy company in India which develops and manages solar, wind, and hybrid power generation facilities and infrastructure. Our three capability centres across Bangalore and Chennai serve as a technology and innovation powerhouse for Shell globally, working as a delivery engine for core technical, digital, and finance processes: pioneering digital innovation and cutting-edge technologies across the energy sector. We also have strong academic partnerships and collaborations with leading universities and technology institutes to accelerate decarbonization efforts within the energy sector. We are committed to positively contributing to the communities in which we operate through programmes on STEM Education, Skilling, and Livelihood across India. We nurture and invest in startups developing initiatives focused on accelerating energy innovation through programs such as Shell E4 and Shell Eco-marathon. We also have strategic investments in new energy companies such as Husk Power, d.light, Orb Energy, and Cleantech Solar.

Keywords: Software Testing Experience: 3 - 10 years Designation / Role: Quality Engineer Location: Chennai Job Description: Job Summary: We are looking for an experienced Software Test Engineer with 3+ years of experience in software testing. Candidates with a background in chemical engineering (BSc/MSc) and prior experience in software development are highly encouraged to apply. The ideal candidate will bring both technical skills and domain understanding to validate software solutions used in scientific, laboratory, or industrial environments. Key Responsibilities: Design, develop, and execute test cases (manual and automated) based on product requirements. Identify, document, and track defects using appropriate defect tracking tools. Collaborate closely with development, product management, and domain experts to understand the product and ensure testing aligns with user expectations. Perform regression, functional, integration, and performance testing. Participate in agile ceremonies and contribute to sprint planning and reviews. Write clear and concise test plans and test documentation. Maintain test environments and datasets for various testing scenarios. Preferred Skills & Qualifications: Bachelor’s or Master’s degree in Chemical Engineering, Chemistry, or related scientific/engineering field. 3+ years of experience in Software Testing (manual or automated). Hands-on experience with any of the test automation tools/frameworks such as Selenium, Playwright, Cypress, etc. Solid understanding of SDLC, STLC, and testing methodologies (Agile/Scrum). Strong analytical and troubleshooting skills. Exposure to test management tools like JIRA, TestRail, Zephyr, etc. Experience working in domains such as scientific software, lab systems (e.g., LIMS), or process control systems is a plus. Prior experience in software development is a strong advantage – especially understanding of code, debugging, and collaboration with developers. Excellent communication and documentation skills. Nice to Have: Experience testing APIs using tools like Postman or REST-assured. Knowledge of scripting languages (Python, JavaScript) for automation. Understanding of chemical/laboratory workflows or industrial automation systems. ISTQB or similar certification is a plus.

Job Title: Quality Manager – NABL / ISO 17025 and ISO 9001 Compliance · Location: Bhopal, Madhay Pradesh · Job Type:- Full-Time/Contract · Department: Quality Assurance / Laboratory Operations · Reports To: Director / HOD and Technical Manager · Salary- 25k-35k ( No salary Bar for Deserving candidates) 1. Job Summary: 2. We are seeking an experienced and detail-oriented Quality Manager to oversee and maintain our laboratory’s compliance with ISO/IEC 17025:2017, ISO9001 and NABL accreditation requirements. The Quality Manager will be responsible for implementing, maintaining, and continually improving the Quality Management System (QMS) to ensure accuracy, reliability, and integrity of test/calibration results in line with national and international standards. 3. Key Responsibilities: I. Develop, implement, and monitor the laboratory’s Quality Management System (QMS) as per ISO/IEC 17025:2017, ISO 9001 and NABL accreditation requirements. II. Ensure continued **NABL accreditation**, manage document control, internal audits, corrective/preventive actions (CAPA), and management reviews. III. Maintain and update quality manuals, procedures, work instructions, and forms. IV. Plan and conduct internal audits and assist in external assessments by NABL or other accreditation bodies. V. Handle non-conformance reports, root cause analysis, and corrective/preventive action implementation. VI. Provide regular training and competency assessments for laboratory personnel on quality practices. VII. Coordinate with technical and administrative staff to ensure implementation of quality policies and continual improvement. VIII. Monitor and analyze key quality metrics and prepare periodic reports for top management. IX. Serve as the point of contact for all NABL / ISO 17025 / ISO 9001 matters and communications. X. Ensure customer complaints and feedback are properly addressed and documented. XI. Ensure traceability and calibration of all laboratory equipment and reference materials. 3. Requirements: I. Bachelor’s or Master’s degree in Science, Engineering, or a related discipline. II. Minimum 3–5 years of experience working in a laboratory accredited to ISO/IEC 17025, ISO 9001 and NABL. III. In-depth knowledge of ISO/IEC 17025:2017, ISO 9001 standard and NABL requirements. IV. Experience in internal & external (physical) auditing, Visual Audit, NABL audit and management of QMS. V. Experience in department official’s physical audit. VI. Strong communication, analytical, and problem-solving skills. VII. Proficiency with quality documentation and reporting tools. VIII. Certification in **ISO 17025 Internal Auditor** or **Lead Auditor** (preferred). 4. Preferred Qualifications: I. Certification in ISO 17025, Internal Auditor or Lead Auditor (preferred). II. Prior experience in testing, calibration, or a regulated laboratory environment. III. Familiarity with statistical quality control tools and laboratory information management systems (LIMS). IV. Exposure to other quality standards such as ISO 9001 or Good Laboratory Practices (GLP). 5. Remuneration: Commensurate with experience and industry standards. Show more Show less

Role & responsibilities QMS, CAPA, OOS, OOT, CHANGECONTROL, Preferred candidate profile B.Sc / M.Sc Chemistry With relevant experience Perks and benefits

Role Description Job Description We are looking for an experienced Business Analyst with strong domain expertise in SampleManager LIMS and cross-industry exposure (Pharma, Oil & Gas). The ideal candidate should possess excellent analytical and documentation skills, a deep understanding of business processes, and experience in end-to-end LIMS implementations. The role demands effective client interaction, solution design, and strong collaboration with development teams. Key Responsibilities Gather, analyze, and document business requirements from stakeholders. Design solutions aligned with business needs and regulatory requirements. Act as a liaison between clients and technical teams to ensure successful solution delivery. Lead or participate in end-to-end SampleManager LIMS implementations. Handle project management tasks using tools like JIRA, and ensure timely delivery. Work independently with clients, manage expectations, and provide consultative guidance. Contribute to RFPs, bidding processes, and effort estimations. Ensure compliance with GxP regulations, validation practices, and documentation standards. Support both Agile and PMP-based project methodologies. Essential Skills & Qualifications Strong hands-on knowledge of SampleManager LIMS. Proven experience as a Business Analyst on at least one major LIMS project. Prior knowledge of Pharma and Oil & Gas domain processes. Experience with instrument interfacing techniques and lab workflows. Proficiency in using project management tools such as JIRA, MS Project, or similar. Strong understanding of Agile and PMP methodologies. Excellent analytical, communication, and stakeholder management skills. Strong documentation abilities that cater to both technical teams and business users. Preferred Skills Involvement in RFP, proposal creation, and estimation processes. Knowledge of compliance standards such as 21 CFR Part 11 and ALCOA+ principles. Experience working in regulated environments with exposure to audit processes. Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less

Role Description We are seeking a LIMS Associate Engineer with 4 to 7 years of experience, specializing in SampleManager LIMS . The ideal candidate will possess strong technical skills, a good understanding of laboratory practices in the pharmaceutical domain, and hands-on experience in LIMS development and configuration. Key Responsibilities Design, develop, and configure SampleManager LIMS modules including: Sample workflows Stock module Instrument module Instrument Interfacing using Integration Manager Report Designer, Forms Designer, Label Designer Sample Scheduler Batch Management, Lot Management, Plate Handling Stability, SQC, SM-IDI, PIMS, and Dashboards Participate in and contribute to at least 1–2 LIMS implementation or development projects. Handle instrument interfacing, calibration, and maintenance tasks within LIMS. Write and optimize database queries; support report generation and form design. Ensure robust testing, documentation, and adherence to validation practices. Follow ITIL guidelines and support processes for incident and change management. Collaborate with cross-functional teams and be proactive in taking on technical challenges. Required Skills & Qualifications Strong hands-on experience with SampleManager LIMS development and configuration. Prior experience in pharmaceutical laboratory practices and GxP environment. Good understanding of instrument interfacing, calibration, and maintenance integration. Experience in SQL/DB management, report development, and LIMS form design. Familiarity with ITIL processes, change control, and support ticket resolution. Strong analytical, documentation, and validation skills. Ability to work independently and manage multiple tasks effectively. Preferred Skills Experience with dashboards and KPI reporting within LIMS. Exposure to SampleManager IDI (SM-IDI), PIMS, and SQC modules. Knowledge of regulatory compliance (e.g., 21 CFR Part 11, ALCOA+ principles). Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less

Job Title: QC Data Analyst Shift Timing: 7AM-4PM IST or 8AM-5PM IST (flexible) Role Overview: We are seeking a QC Data Analyst to analyze and interpret food sample data, ensuring compliance with quality standards. This role involves verifying data accuracy, investigating non-compliant results, and collaborating with production teams to resolve issues. The analyst will also prepare reports and perform statistical analysis to assess product quality. Key Responsibilities: Review test results, generate COAs, and verify data Perform calculations and investigate discrepancies Initiate investigations and recommend corrective actions Record data in LIMS Identify trends, assess data quality, and communicate findings Required Skills: Strong analytical and problem-solving abilities Attention to detail and accuracy Excellent communication and documentation skills Knowledge of quality standards Education: Bachelor / Master / Ph.D degree in food science, microbiology, chemistry, or related field Show more Show less

Job Purpose Candidate should be full-timeDiploma in Metallurgy/ Mechanical or BSC/ MSC in Chemistry & having experience in extrusion, SRS & FRP with 0-3 years of experience in Fundamentals of the metals industry laboratory. Candidate should have technical knowledge and understanding of Lab Methods, Instrument Calibration, Sample preparation, Sample cataloging, Test records & Reporting, LIMS, Microscopy, metallography, Spectroscopy, ILC testing, Mechanical Testing, PodFA, Grain Size MeasurementMust have good Interpersonal skills and ability to communicate with all levels of the workforce. The candidate should have a working knowledge of manufacturing quality systems. Should be very good in teamwork, Service Orientation & customer focus to implement and effectively develop within predefined parameters like timeline, production targets, etc. Show more Show less

About ICBio Clinical Research Pvt. Ltd.: Headquartered in Bengaluru, India, ICBio is a full-service Contract Research Organization (CRO) with over 16 years of experience in conducting Bioavailability/Bioequivalence (BA/BE) studies and Phase I–IV clinical trials. We have successfully completed over 1,000 BA/BE studies and approximately 500 clinical trials. Our services are approved by several global regulatory bodies, including ANVISA Brazil, DCGI, CDSCO, MHRA, UAE MOH, GCC, MOH Kazakhstan, and Zambia . Our NABL-accredited central laboratory is fully integrated with LIMS, ensuring high-quality data and compliance. Our Services Include: Bioavailability/Bioequivalence Studies Phase I–IV Clinical Trials Bioanalytical Services Regulatory Affairs and Dossier Preparation Pharmacovigilance Clinical Data Management and Biostatistics Medical Writing job responsibilities Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements. Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines. Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOP’s are available in work place. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Ensure computerized systems used in the studies has been validated as per the regulatory requirement. Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure. Approve the individual sample repeats, ISR and investigation of batch failures. In case of any deviation from the protocol, assess and document the impact on the quality and integrity of the study and take appropriate corrective action when necessary. Ensure regular instruments backup and study related documents are archived properly. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

Reference ID R177736 Updated 05/28/2025 Production and Manufacturing Downstream India Chennai N/A What's The Role The FPP Scheduling Advisor aids sites to deliver maximum value from margin optimization activities implementing planning and scheduling work processes, increasing staff competencies, assuring accurate representations in optimization and scheduling models (including gasoline blending). They provide deep expertise in the understanding and use of the site Scheduling Models for Refinery and Chemical site planning through the deployment of cutting-edge technology. The Advisor works in close collaboration with site E&S teams, TAS E&S team, P&T Basic Data, Scheduling, Crude and FPP Excellence Advisors. The FPP Scheduling Advisor Role is seen as critical to ensuring that the E&S community is well supported and to help maximize value generation from our sites. This role is expected to be fully accountable for the activities below. What You'll Be Doing MODELING Acts as primary technical expert for E&S Scheduling tool (currently Aspen’s APS/Orion), supporting site Scheduling teams. (Scheduling and Blending) Supports practitioners with urgent problem solving to ensure business continuity and escalates to central TBI Optimization Advisors or 3rd Party vendor as appropriate. Implements new advanced simulation and optimization capabilities and better representation (including visualization) of process plants in Scheduling tools. Supports in the assurance that scheduling models are lean, up to date and changes are communicated amongst Scheduling and Planning Advisors and EMC’s to ensure alignment between PIMS, Orion and MBO models. Provides support to configure all existing and new reports from the tools. Supports programming, testing, enhancements, configuration, maintenance of non-IT supported data input and Solution reports. Maintain best practice recommendations in a structured fashion and help propagate these within the E&S practitioner community for Scheduling and Blending. Support in effective backcasting activity and practices that ensures the health and fidelity of the relevant submodels, databases, data tables, model logic, stream routings, blend rules and properties, with the intent of constantly driving optimal solutions and decision making by the practitioners. TRAINING / DEVELOPMENT Supports with the onboarding of new employees with scheduling tools and all relevant FPP work processes. MARGIN OPTIMIZATION STUDIES Support with structured margin improvement interventions and ensures / assists with implementation of recommendations as relevant with Scheduling and Blending capability of sites. DATA INTERFACES Ensures validation of data flows of daily baseline data interface configurations (PI and LIMS), all movement interface configurations and all hourly plant data (PI and LIMS) into the ‘model accuracy’ graphs (configuration, troubleshooting, and display) Coordinate data interface bug fixes or enhancements with IT. INSTALLATIONS AND TROUBLESHOOTING Provides business advice to DS IT regarding Scheduling/Blending PC software installations and helps troubleshooting where needed Configure and support maintenance of Add-ons (with data tables/files) for standard and site relevant work-processes. Coordinate Add-on bug fixes or enhancements, Beta Testing and User Acceptance testing with IT. DATABASE MANAGEMENT Coordinates database table purge requirements (retention days/dates) to stay consistent with site work processes and to prevent the database size from causing failures in MDB backup creation. Corroborates with IT to ensure all SQL and MDB backup creations are complete and routine (which involves oversite/monitoring). Provides site database user account management, including user group model/event permissions configuration setup and changes. Provides maintenance, programming, and updating of the site MDB Pass-through database (including up-to-date AspenTech data queries). GENERAL E&S SUPPORT Ensures compliance with the requirements and consistent application of the FPP planning work processes in AMS and assists with the closure of recommendations. Scheduling Advisor will lead regional Scheduling networks with support from a sponsoring E&S Manager. CHALLENGES Networks will play a key role in the new organizational setup to ensure peer-to-peer collaboration and support between the various sites, as well help in ensuring best practices in the relevant areas are being pursued at all sites. The Advisor will network with their colleagues in the Europe and Americas regions to ensure inter-regional connectivity. What You Bring Preferably with a University Degree in Chemical Engineering or Petroleum Engineering, with relevant refinery oil and gas experience. Preferably with at least 6 years of experience in refinery planning and scheduling space working with planning tools or Software Industry associated with developing product and tools for Refinery Planning and Scheduling space Preferably with mastery level experience in Aspen Petroleum Scheduler (APS) / Aspen Unified Scheduling (AUS) Has deep knowledge around the utilization of hydrocarbon and refinery economic value drivers Able to demonstrate commercial mindset to identify and drive margin opportunities to delivery Excellent analytical, oral and written communication skills Team player and self-motivated. What We Offer You bring your skills and experience to Shell and in return you work with talented, committed people on one of the most important challenges facing our planet. You’ll have the opportunity to develop the skills you need to grow in an environment where we value honesty, integrity and respect for one another. You’ll be able to balance your priorities as you become the best version of yourself. Progress as a person as we work on the energy transition together. Continuously grow the transferable skills you need to get ahead. Work at the forefront of technology, trends and practices. Collaborate with experienced colleagues with unique expertise. Achieve your balance in a values-led culture that encourages you to be the best version of yourself. Join an organization working to become one of the most diverse and inclusive in the world. We strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation and life experiences to apply. Grow as you progress through diverse career opportunities in national and international teams. Gain access to a wide range of training and development programs. Shell in India Shell is a diversified energy company in India with 13,000 employees, and presence in Integrated Gas, Downstream, Power, Renewable and Upstream. Additionally, we have deep capabilities in R&D, digitalisation, and business operations. Our global strategy, Powering Progress, is designed to generate value for our shareholders, customers, and the wider society, and focuses on creating more value with less emissions. The strategy supports our purpose of providing more and cleaner energy solutions, with the aim of profitably transforming Shell into a net-zero emissions energy business by 2050. As India moves towards its target of net-zero emissions by 2070, Shell India aims to play a leading role in securing vital energy for today, while investing in, and helping to build, the energy system of the future through strategic investments in the country. Our Lubricants business serves over 50,000 consumers through a strong network of over 200 distributors, and operates an end-to-end value chain that spans conceptualization, development, and production at a world-class blending plant at Taloja. Through our 350-plus retail stations, we offer an integrated mobility experience including fuels, cafes, and convenience stores, with a prominent network of EV recharging facilities. Shell owns and operates a LNG re-gasification terminal at Hazira, Surat, with a capacity of 5 MTPA and a LNG truck-loading unit that plays a crucial role in helping meet India’s growing demand for gas across sectors. In 2022, Shell acquired Sprng Energy in a $1.55 billion deal to build an integrated energy transition business in the country. Sprng is a leading renewable energy company in India which develops and manages solar, wind, and hybrid power generation facilities and infrastructure. Our three capability centres across Bangalore and Chennai serve as a technology and innovation powerhouse for Shell globally, working as a delivery engine for core technical, digital, and finance processes: pioneering digital innovation and cutting-edge technologies across the energy sector. We also have strong academic partnerships and collaborations with leading universities and technology institutes to accelerate decarbonization efforts within the energy sector. We are committed to positively contributing to the communities in which we operate through programmes on STEM Education, Skilling, and Livelihood across India. We nurture and invest in startups developing initiatives focused on accelerating energy innovation through programs such as Shell E4 and Shell Eco-marathon. We also have strategic investments in new energy companies such as Husk Power, d.light, Orb Energy, and Cleantech Solar. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Control Executive & Sr. Executive injectables &OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. Quality Control 1.Finished Products 2.Raw Materials 3.Packing Materials 4.Caliber The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in Thanks and Regards Prasanthi - Dashboards Team HR

Overview Position summary statement: The Specialist, Document Control in Information Technology at Herbalife International is an outstanding opportunity to be part of a proven, world-class team. This role is integral to ensuring the flawless execution of our document control processes, collaborating with various departments to maintain high standards of accuracy and efficiency. Your ability to strictly manage data, determine priorities, and successfully implement projects will be key to our success! Detailed Responsibilities/duties Begin and complete gathering and analyzing documents using the Ingredient Document Checklist (IDCI/IDCO) in Agile. Design, manage, and complete document management projects for Inner and Outer Nutrition raw materials. Lead design and execution of projects efficiently; achieve timelines and desired results by effectively prioritizing tasks and projects. Maintain sourcing databases, including vendor lists, to ensure accurate reporting; review and analyze reports. Collaborate with Global Strategic Sourcing (GSS) and Document Control Scientists to resolve identified issues. Contact raw material suppliers or contract manufacturers to gather raw material documents. Manage LIMS for assigned tasks and responsibilities. Resolve customer needs expeditiously and support supplier relationships. Influence other departments to reach mutual agreements. Manage raw material samples for analysis. Maintain raw material project lists to ensure accurate reporting. Support process improvement initiatives. Perform other responsibilities as assigned. Qualifications Skills: Outstanding written and verbal communication skills with an organized thought process. Strong analytical skills with the ability to draw conclusions and solve challenging problems. Experience dealing with raw material vendors and contract manufacturers. Advanced computer skills (Microsoft Excel, Word, PowerPoint, Outlook). Ability to build relationships and promote a positive working environment. Sense of urgency and ability to balance multiple projects, achieving timely and desired results. Strong organizational skills and attention to detail. Openness to change and new methods. Great teammate capable of collaborating with associates from other regions. Awareness of business strategies and tactics in the marketplace. Good listening skills one-on-one and in groups. Ability to express personal viewpoints constructively and directly. Experience Minimum of 5 years in Quality Assurance, Regulatory Affairs, R&D, or Sourcing. Education Bachelor’s Degree in a Scientific field or equivalent experience required. Terms of Use Privacy Policy Compliance Documents CSR Policy Show more Show less

Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About The Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e.g., LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth). Minimum Requirements Technician or Bachelors/Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. Fluent in English (oral and written).Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Chemical Testing: Perform chemical test like FTIR, NMR, GC-MS, and titration to analyze the chemical composition of polymer Data Analysis, Sample Preparation Knowledge of statistical analysis technique quality management system, such as ISO 9001 Required Candidate profile Bachelor’s degree in chemistry, Polymer Science, Chemical Engineering Strong understanding of polymer chemistry and materials science We have 2 vacancies – 1 Male & 1 Female candidate.