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20.0 years

0 Lacs

Gurugram, Haryana, India

On-site

Requisition Id : 1629420 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that it’s your career and ‘It’s yours to build’ which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity : Consultant-CHS-Business Consulting Risk-CNS - Risk - Digital Risk - Gurgaon CHS : CHS consists of Consumer Products and Healthcare sectors. Consumer products largely entail, Retail and Agri business. Companies in this sector meet the demands of consumers all around the world, every day; providing everything from agricultural crops to food, clothes, durables and retail experiences. We help clients to capture new sources of profitable growth, rethinking how and where they bring value to consumers, today and into the future. Incumbents need to shift their focus from defending what they have to creating what they need to become. The Health Sciences & Wellness architecture brings together a worldwide network of professionals to build data-centric approaches to customer engagement and improved outcomes. To retain relevancy in today’s digitally focused, data-infused ecosystem, all participants in the sector must rethink their business practices, including capital strategy, partnering and the creation of patient-centric operating models. CNS - Risk - Digital Risk : EY Consulting is building a better working world by transforming businesses through the power of people, technology and innovation. Our client-centric approach focuses on driving long-term value for our clients by solving their most strategic problems. EY Consulting is made up of three sub-service lines: Business Consulting (including Performance Improvement and Risk Consulting), Technology Consulting and People Advisory Services. We help our clients in identifying and managing the interplay between upside and downside risk in order to make the long-term decisions to prevent risk and impact on their organization's ability to meet its future business strategy and objectives. The 3 key fields of play are : Enterprise Risk - helps clients identify and address key risk areas, while building the agility to respond quickly. The areas of focus include Enterprise risk and resilience, Internal audit, Compliance and Internal controls Technology Risk - helps clients to achieve sustainable growth by supporting their efforts to protect their business performance and by providing trusted communications on internal control and regulatory compliance to investors, management, regulators, customers and other stakeholders. EY teams accomplish this by assessing the technology risks that are introduced to businesses. Financial Services Risk - helps clients in the financial sector to identify, manage and monitor the risks in their business. It is done through a transformative and agile approach including process and procedures, risk, data modeling and analytics, reporting to stakeholders and third parties, business requirements (for software selection and IT implementation), analysis of assets and liabilities, and capital and liquidity management. Your key responsibilities Technical Excellence Expert in setting IT integration landscape setup from ground ZERO with partners. Developed more than 1000+ interfaces which includes End to end integration with CMO’s , 3PL’s , Serialization tools using SAP ATTP , SAP PI/PO , LIMS , Trackwise Ivalua , SAP ICH , Tracelink etc , Packaging line applications , Optel Vision , ACG etc. Experienced in EDI capability setup for Sales and Operation Planning , PTP, OTC, 3PL etc. Integration with iOT applications over Azure/AWS for measuring the efficiencies on real time basis for critical decision-making. Experience in setting up SAAS applications like Salesforce ,iValua, BIZOM , WareIQ , SAP ICH , Oracle HRMS , SAP Concur , Happay , Planning applications like GAINS etc Experience in Artwork application like Goose , Mass mailer applications, SharePoint etc Implemented GST/e-Way Bill and e-Invoicing solution Integration with various banks for payment processes and with Oracle FCCS i.e Hyperion for consolidation Sales automation via implementing solutions like Field force automation , CRM implementation and integration with ERP , BIZOM , Ware IQ etc. Automation of multiple operational processes via UiPath .Saving of 8-10 man hours every day . SAP Carve out, Rollout , SAP Upgrade projects etc. Skills and attributes To qualify for the role you must have Qualification M.C.A Trained and Certified in SAP PI/PO , SAP application. Certified in TOGAF , ITIL V3 , Solace Experience Santosh is a seasoned Integration expert with nearly 20 years of experience in the Life Sciences sector. He has developed various complex integration in pharmaceuticals domain for applications like – Serialization(SAP ATTP/SAP ICH/ Optel),LIMS(Labvantage), QMS/WMS(SAP , 3rd party) external databases, APIs, and analytics tools. His expertise in leveraging Web Services enables seamless data flow and compliance across systems, supporting efficient operations and informed decision-making in highly regulated environments What we look for People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful and able to sustain postivie energy, while being adaptable and creative in their approach. What we offer With more than 200,000 clients, 300,000 people globally and 33,000 people in India, EY has become the strongest brand and the most attractive employer in our field, with market-leading growth over compete. Our people work side-by-side with market-leading entrepreneurs, game- changers, disruptors and visionaries. As an organisation, we are investing more time, technology and money, than ever before in skills and learning for our people. At EY, you will have a personalized Career Journey and also the chance to tap into the resources of our career frameworks to better know about your roles, skills and opportunities. EY is equally committed to being an inclusive employer and we strive to achieve the right balance for our people - enabling us to deliver excellent client service whilst allowing our people to build their career as well as focus on their wellbeing. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now.

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10.0 - 15.0 years

8 - 12 Lacs

Aurangabad

Work from Office

Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong understanding of instrument calibration procedures under cGMP regulations. Proficiency in maintaining IQ, OQ, PQ documentation for laboratory equipment.

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70.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. YOUR ROLE The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Research Associate II, Stability Subject Matter Expert, applies sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics. The effective integration of chemistry and stability enables establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements. What You Will Be Doing Represent R&D–Stability on project teams as a member of the project teams’ goals and success. Support development and implementation of stability strategies for new product development and sustaining project activities. Support development of GMP stability studies used to establish expiration dating and support labeling for product development. Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners. Provide valuable input to stability assessments and requirements for new products and/or current product changes. Ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life. Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale. Interact with manufacturing facilities to acquire information related to test methods and specifications. Author, review and verify technical data, protocols, and reports through use of Quality Documentation System. Act as study director for stability projects under guidance of senior Stability team members. Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry. Support development of new and/or optimization of existing processes and procedures to enhance stability related practices. Participate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members. Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles. Contribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, summarize data for reporting. What You Will Bring Under guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail. Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members. Experience working with sophisticated databases. Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools. Good technical writing skills. Proficient in analytical chemistry including theoretical knowledge and practical experience. Willingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met. Basic functional understanding of FDA, ISO, and Quality systems. Works well in a team environment across multiple time zones and demonstrates an inclusive attitude. Education And/or Experience Bachelor’s Degree with 8-12 years or Master’s degree with 6-10 Years in a relevant scientific subject area. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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170.0 years

0 Lacs

Mulshi, Maharashtra, India

On-site

About Birlasoft Birlasoft, a global leader at the forefront of Cloud, AI, and Digital technologies, seamlessly blends domain expertise with enterprise solutions. The company’s consultative and design-thinking approach empowers societies worldwide, enhancing the efficiency and productivity of businesses. As part of the multibillion-dollar diversified CKA Birla Group, Birlasoft with its 12,000+ professionals, is committed to continuing the Group’s 170-year heritage of building sustainable communities. About the Job – We are looking for SAP PP & QM Technical Architect. Educational Background – Any Graduate. Experience- 10+ years. Location- Pune/Bangalore/Chennai/Mumbai Key Responsibilities Key Responsibilities Should have overall 10+ years of experience. Should have at least 3 to 5 end-to-end ECC and S/4HANA implementations with experience in leading any of Logistics tracks (OTC or PTP or SCM) in projects. Deep knowledge of PP and QM module functionalities and best practices. Demand Management, Serial number, Digital signature and ABAP debug is essential to work on this project. Deep Knowledge of Master data, processes and functionalities offered in S/4HANA in any of the logistics areas. Proven experience of handling integrations with other modules (MM, CS, FICO, PP, PM) and Industry cloud Applications. Act as the functional expert, ensuring quick turnaround in identifying application issues and providing timely solutions. Hands on experience in Service now. Expert in handling support, development and rollout projects. Expert in writing documents like Functional specifications, Business process documents and Functional documents. Experience with different integration systems like LIMS, BizTalk etc. Knowledge in PLM system with ECS DB is an added advantage. Knowledge in Label printing software’s like BarTender, TLAshford/BPCS is added advantage. Knowledge of SAP MII is an added advantage. Provide consulting services on new and existing initiatives.

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1.0 - 3.0 years

2 - 2 Lacs

Navi Mumbai

Work from Office

Responsible for sample management procedure. Review test request from. Fill sample check list. Maintain sample Id register/sample list/Client communication. Temperature monitoring. Hold sample list update to QA, QC and Pharma Head monthly basis. Required Candidate profile LIMS handling with respect to Data entry, sample login and code generation. Maintain MSDS of different Product. Client follows up with respect to Hold sample. Prepared COA & ROA. Invoice.

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2.0 - 4.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for monitoring, auditing and assuring the quality of operational aspects of the Facility according to established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements with support of auditors & other senior members. Job Responsibilities Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable. Performs audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations. Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable. Prepares QA audit reports for all the above audits/surveillances performed. Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings. Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility. Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures. Revise, implements, and maintains records of standards Operating procedures and additional relevant documents for the facility. Assists in Internal Audits whenever required. Reports to QA Management with respect to the operational status and disposition of all matters relating to the operations in the QA unit. Performs all work in accordance with all established regulatory and compliance and safety requirements. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Minimum Bachelor Degree holder in Science or Pharmacy. Knowledge, Skills and Abilities Knowledgle on current Guidelines like ICH Guidlines ,GCP and GLP for BA/BE studies Technical skills on LIMS, EP and Analyst software. Ability to perform audits in accordance to GDP, GLP and GCP and other requlatory requirements. Experience Minimum 2-4 years Experience in Regulated Industry. At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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4.0 - 8.0 years

4 - 8 Lacs

Thiruvananthapuram

On-site

About the Role We are building a next-generation SaaS platform for dental clinics across India, the Middle East, and Southeast Asia. Our platform will simplify clinic operations, patient engagement, appointment scheduling, billing, and compliance. We are looking for a passionate and execution-driven Product Manager to lead product development from ideation to launch and growth. Key Responsibilities Own the product roadmap and define feature priorities based on customer needs and business goals Conduct market research, competitor analysis, and user interviews to validate and refine product features Write detailed PRDs, user stories, and acceptance criteria Collaborate with designers, developers, and QA to ensure smooth and timely delivery of features Drive sprint planning, standups, and backlog grooming in Agile environments Define and monitor product success metrics (e.g., adoption, engagement, retention) Work closely with marketing and sales to align product positioning and go-to-market (GTM) strategies Coordinate with support teams to resolve issues and gather user feedback for continuous improvement Must-Have Skills 4–8 years of experience in product management (preferably B2B SaaS or health tech) Strong understanding of product lifecycle, SaaS metrics, and Agile methodology Ability to define and track KPIs (activation rate, churn, CAC, LTV) Experience working with cross-functional tech teams (design, dev, QA, sales, support) Good understanding of cloud-based architecture, APIs, and mobile-web products Excellent communication, documentation, and analytical skills Preferred Qualifications Prior experience in healthcare, dental, or ERP-related platforms Familiarity with tools like Figma, Jira, Notion, Trello, Redmine, Google Analytics, or Mixpanel Understanding of compliance requirements (HIPAA, GDPR) Experience with SaaS GTM strategies including freemium or referral models Bonus Points Built or scaled a SaaS product from scratch Exposure to global markets (India, GCC, Singapore) Technical background (Engineering or CS) and/or MBA Job Types: Full-time, Permanent Pay: ₹35,000.00 - ₹70,000.00 per month Experience: Product Manager: 5 years (Preferred) Health care SAAS software: 5 years (Preferred) Work Location: In person Application Deadline: 30/08/2025 Expected Start Date: 25/08/2025

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3.0 years

4 - 10 Lacs

Hyderābād

Remote

Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. Job Description 3 years’ experience managing software development teams in a distributed and global setup, including leadership of both internal and outsourced/offshore development teams 3+ Experience with multi-modal collaboration (in-office, hybrid and remote), and collaboration across time zones 5+ years of experience planning and delivering software projects within and across teams, including resource allocation and managing cross-functional dependencies. Ability to build clear and realistic project delivery plans 10+ years of software development 8+ years of programming experience in Java 5+ years of experience with HTML/CSS/JavaScript 5+ years of experience developing or using facing RESTful APIs Expertise in data modeling and developing schemas (relational databases, XML/JSON) Experience in developing LIMS Applications, such as LabVantage Experience with Amazon Web Services or similar cloud architectures Experience working in a fast-paced environment leveraging an agile development framework Qualifications B.S. or higher degree in computer science, engineering, or related areas Additional Information To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants . Please visit our career page at: http://www.guardanthealth.com/jobs/

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12.0 years

4 - 7 Lacs

Hyderābād

On-site

About the Job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process Deliver innovative "state of the art" tools enabling performance for manufacturing processes Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently Role Overview: The MES DevOps Manager is responsible for leading the delivery, design/ build/ implementation and continuous enhancement of global end-to-end Manufacturing Execution System (MES) solutions at Sanofi. This role focuses on team mgt/leadership, technical mgt/expertise, and delivery excellence to ensure MES configurations meet the needs of Sanofi's manufacturing operations while adhering to quality, regulatory, and cybersecurity requirements. The manager will manage a team (functionally, technically and administratively) of MES DevOps Engineers and MBR developers, take the ownership/leadership of technical delivery of the team to answer to the requirements of manufacturing sites and align with the expectations of the product owner (Siemens OPCenter) and capability manager. Main Responsibilities Systems & Processes in Scope Main MES Systems: Siemens MES Opcenter Execution Pharma Product Siemens Equipment logbook Pharma Main platform : Mendix Business Processes Covered: Master data management (items, user rights, equipment, locations, work orders) Master batch record design & approval (including workflows) Master batch record review & approval (by Exception) Templates for elogbook Instructions on Operating Text Production execution Weighing & Dispensing Communication to equipment or SCADA systems Equipment management Material flow management Traceability / Genealogy Labelling Reporting Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE) Key Responsibilities: 1. Team Leadership and Management: Lead and manage a team of MES DevOps Engineers and MBR developers Facilitate onboarding and integration of team members as they join the organization Drive knowledge building and skill development within the team. Foster a culture of continuous learning and best practice sharing among team members Ensure team members are prepared and able to travel to Sanofi industrial sites globally (Europe, NA, Asia) where MES is in use. And ensure team members are developing a closed partnerships with sites users & business system owners to guarantee a full understanding of business requirements, stakes, challenges, constraints & ultimately build efficient solutions Managing the priorities of the team, Facilitating resource allocation and management for various MES projects across Digital Manufacturing & Supply Taking the ownership/leadership of technical delivery of the team, ensuring knowledge transfer, and contributing to operational excellence to answer to the requirements of manufacturing sites and align with the expectations of the product owner (Siemens OPCenter) and capability manager. 2. Technical Expertise and Team Development: Assess and enhance the technical capabilities of the team Identify skill gaps and implement targeted training and development programs Establish mentoring relationships to accelerate team members' growth and expertise Create a collaborative environment that encourages innovation and problem-solving Ensure the team stays current with evolving MES technologies and industry best practices Develop leadership & accountability at each individual level 3. Technical Configuration and Solution Design: Oversee the design and build of MES configurations, ensuring alignment with standard market solutions and Sanofi best practices Coordinate / align with expectations of Product Owner for Siemens OPCenter to support configuration, implementation, and deployment projects Guide the team in developing MBRs, Process Instructions, blocks, and templates according to functional specifications Establish configuration strategies that leverage market solutions and align with industry best practices and Ensure configurations align with the Core model and operational excellence standards 4. Delivery and Quality of Services: Drive timely and high-quality delivery of configuration projects while maintaining robust, cost-effective solutions Establish and maintain delivery frameworks that ensure consistent, predictable outcomes Implement delivery metrics and KPIs to track performance, quality of service, and team productivity Lead risk mitigation strategies to address potential delivery challenges proactively Coordinate cross-functional implementation activities to ensure smooth deployment/ configurations across different industrial sites Ensure compliance with legal and regulatory requirements (GxP, Data Privacy, SOX, etc.) Establish delivery governance to maintain transparency and accountability throughout the delivery lifecycle Oversee the implementation of various MES projects, including product builds and data foundations, maintaining accountability for the results delivered by MES DevOps Engineers and MBR developers Work closely with product owners and across MES teams to develop and implement strategies supporting product build and configuration, delivery, implementation projects Ensuring optimal resource allocation and project outcomes 5. Operational Excellence and Continuous Improvement: Drive the implementation of best practices in MES configuration and development Identify opportunities for process optimization and efficiency improvements Lead initiatives to streamline workflows and enhance productivity Collaborate with cross-functional teams to align MES configuration with broader organizational goals Promote a culture of quality and continuous improvement within the team and across projects Develop culture of empowerment, ownership, Thoughtful risk taking 6. Stakeholder Management: Collaborate with MES Product Owner, Service manager, capability manager and lifecycle manager and users/ manufacturing sites Work with Enterprise Architects, solution architects, Quality and the Cybersecurity team to review & qualify configuration designs Communicate effectively with Digital management teams, staff, and business stakeholders Oversee trainings & knowledge transfer and best practice sharing between the team and sites Ensure the team provides effective functional & technical support throughout the solution lifecycle 7. Business Alignment and Innovation: Analyze business requirements for various processes, providing direction to challenge, consolidate, and develop solutions expandable to multi-business unit use cases Develop strategies to maximize customer satisfaction while minimizing build and maintenance costs and risks Guide the strategic evaluation of configuration options and assess/manage associated risks Remain current on technology trends and benchmark with other companies to bring innovative inputs to solutions Lead initiatives to evolve GxP Validation approaches to simplify and adapt to next-generation technologies Required Skills and Qualifications: Experience & Knowledge: 12+ years of work experience in Digital Manufacturing domain, with 8+ years of experience in MES, specifically Siemens OPCenter Execution Pharma and Siemens Equipment Logbook Strong team management experience with demonstrated success in leading and developing technical and functional teams Proven track record of successful delivery of complex technical solutions in regulated environments Demonstrated experience in managing delivery timelines, resources, and quality simultaneously Experience in multicultural, multilanguage environments and matrixed organizations Broad knowledge of manufacturing processes in pharmaceutical industrial plants Strong MES experience: market standards knowledge (solutions, technologies, integration, architecture) Experience & understanding of core product/model concept Technical Skills: Expertise in MES solutions: Siemens OPCenter Execution Pharma Strong knowledge of Manufacturing Execution Systems, including Master Batch Record and Review by Exception business processes Solid understanding of manufacturing processes in pharmaceutical plants Strong knowledge of pharma industry regulatory context (GxP) Knowledge of solution architecture, integration, and infrastructure technologies Knowledge of Automation layer (SCADA, DCS, PLCs, industrial protocols) Experience & knowledge of Mendix/ low-code platforms Knowledge of scripting (VB etc.) is a plus but not required Soft Skills: Strong leadership capabilities with proven ability to inspire and develop teams High degree of accountability and proactive problem-solving mindset Results-oriented approach with strong focus on delivery excellence Excellent interpersonal and communication skills Ability to build and maintain strong relationships across all organizational levels Customer-centric approach with focus on delivering value Collaborative team leader & player with experience in matrix organizations Change management expertise and ability to adapt to dynamic environments Strategic thinking with strong decision-making abilities Agile methodology practitioner Ability to manage competing priorities and resilience to deliver under pressure Education: Engineering degree or Master's in Computer Science or related field (or equivalent experience) MBA or equivalent business management qualification is a plus Language: Fluency in English, other languages are a plus Working Environment: Occasional travel requirement to manufacturing sites in Europe / North America/ Asia Global, matrix organization environment Must be able to work effectively across different time zones and cultures Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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12.0 years

0 Lacs

Hyderābād

On-site

About the Job Context: As part of Sanofi's initiative to standardize processes and drive digital transformation across Manufacturing & Supply, this role is crucial in orchestrating the lifecycle management of MES systems, including the MARS (MES Accelerated Roadmap @ Sanofi) implementations across multiple production sites globally. Job Summary: The MES Lifecycle Manager drives the strategic planning and execution of MES installations, updates and migrations across Sanofi's industrial network and the lifecycle planning in alignment with the Product Owner Vision & product Roadmap. This role provides technical and strategic leadership in developing and implementing long-term strategies to optimize MES performance, reduce obsolescence, and align MES capabilities with Sanofi's digital transformation goals. Main Responsibilities: Strategic MES Lifecycle Management: Develop and execute a comprehensive MES lifecycle planning/ strategy aligned with Sanofi's digital transformation objectives, Product Owner Vision & product Roadmap Orchestrate high-level planning of MES installations, updates, and migrations across global industrial sites Create and implement strategies to reduce system obsolescence and optimize MES performance across the network Lead and coordinate multiple concurrent MES lifecycle initiatives through effective coordination Implementation Strategy & Site Engagement: Establish strong collaboration and coordination with manufacturing sites for planning of updates, installations, and migrations Partner with site leadership to ensure MES lifecycle activities align with production schedules and business priorities Facilitate communication between digital teams and manufacturing sites to ensure mutual understanding of requirements and constraints Develop site-specific implementation strategies that minimize disruption to manufacturing operations Leadership & Projects/ initiatives oversight: Drive & coordinate multiple MES lifecycle initiatives, ensuring alignment with stakeholders, PO and objectives Establish effective governance practices to support MES lifecycle management Drive decision-making processes, balancing technical, business, and compliance considerations Apply project management approaches to ensure successful execution of MES lifecycle initiatives Develop roadmaps and timelines for MES lifecycle activities across sites Act as direct lead of external coordinators globally/ across the world Digital Transformation & Innovation: Spearhead the evolution of MES capabilities by leveraging emerging technologies such as AI, Cloud services, and DevOps Collaborate with leadership to define the future state of manufacturing systems and drive digital innovation Drive strategic initiatives to enhance integration between MES and other critical systems (ERP, SCADA, LIMS, etc.) Change Management: Guide change management efforts to ensure successful adoption of new MES technologies and processes Align diverse stakeholders across IT, Manufacturing, Quality, and Business units to support MES lifecycle initiatives Risk Management & Compliance: Develop risk management strategies for MES lifecycle planning, ensuring GxP compliance and data integrity Collaborate with Quality and Regulatory Affairs to ensure MES strategies meet evolving compliance requirements Foster relationships with key industry groups to stay abreast of emerging trends and regulations Monitor and report on initiative risks, issues, and mitigation strategies Required Qualifications: Master's degree in engineering, Computer Science, or related field 12+ years of experience in pharmaceutical manufacturing systems, with 8+ years' experience on MES, specifically Siemens Opcenter and Werum PAS-X Demonstrated experience in project & initiative management of complex technology initiatives in regulated environments Track record of successful coordination with manufacturing sites on technology implementations Deep understanding of pharmaceutical manufacturing processes and GxP regulations Strong knowledge of MES technologies and their integration with broader manufacturing and business systems Project Management Certification (eg PMP) and Scrum certification are desired Leadership & Soft Skills: Strategic thinking and ability to translate vision into actionable plans Strong interpersonal skills with ability to build and maintain relationships across all organizational levels Excellent project/ initiative coordination and stakeholder engagement capabilities Ability to influence without direct authority and align diverse groups across the organization Change management expertise with proven ability to drive organizational transformation Cultural awareness and sensitivity in global interactions Active listening and empathetic communication style Exceptional communication skills, including ability to articulate complex technical concepts to diverse audiences Strong facilitation skills for cross-functional meetings and workshops Diplomatic approach to stakeholder management Excellent negotiation and conflict resolution capabilities Adaptability and resilience in managing complex, evolving situations Calm and composed under pressure Proactive problem-solving mindset Technical Knowledge: Good understanding of MES solutions (e.g., Siemens Opcenter, Koerber PAS-X) Expertise in managing technology obsolescence, including lifecycle management & risk mitigation Strong knowledge of MES installation, migration, and update methodologies Familiarity with emerging technologies in manufacturing (AI, Cloud) Knowledge of integration approaches for complex manufacturing IT landscapes Knowledge and Experience of JIRA, Confluence Experience of project management methodology and tools – Microsoft Project Experience with system validation and qualification in GxP environments Knowledge of technology refresh strategies and implementation approaches Working Environment: Flexibility to contribute occasionally on operations out of working hours Occasional travel to manufacturing sites in Europe, NA and Asia Global, matrix organization environment Must be able to work effectively across different time zones and cultures Languages: Fluent in English; additional languages are a plus Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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8.0 years

0 Lacs

Hyderābād

On-site

About the job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process Deliver innovative "state of the art" tools enabling performance for manufacturing processes Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently Role Overview The Manufacturing Execution System (MES) DevOps Engineer drive the design, build, and lifecycle of global end-to-end MES solutions. You will ensure local configurations align with the Core model and operational excellence standards while guaranteeing and promoting the right usage of Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments. You will leverage the Digital Portfolio's Detail Design documents, catalogue of services, and existing Core building blocks while supporting sites in troubleshooting and remediation action plans. Working in close collaboration with MES Product Owners, MES DevOps Manager, MBR Developer, MES Full Stack Engineers, MES installers/developers, Product lines, local digital teams, Business Process Owners, Archetype leads, Site modelers, and Shopfloor experts, you will remain current on company standards, Digital industry practices, and emerging standards while contributing to Digital standards maintenance. Systems & Processes in Scope Main MES Systems: Siemens MES Opcenter Execution Pharma Product Siemens Equipment logbook Pharma Main platform : Mendix Business Processes Covered: Master data management (items, user rights, equipment, locations, work orders) Master batch record design & approval (including workflows) Master batch record review & approval (by Exception) Templates for elogbook Instructions for Operating Text Production execution Weighing & Dispensing Communication to equipment or SCADA systems Equipment management Material flow management Traceability / Genealogy Labelling Reporting Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE) Main Responsibilities: Key Responsibilities Understand business requirements (including analytics) for various processes, challenge, consolidate, and extrapolate them to design & build solutions expandable to multi-business unit use cases and plant configurations Maximize customer satisfaction while minimizing build and maintenance costs and risks associated with fulfillment of business needs Implement appropriate services to ensure optimal allocation of all available capabilities Evaluate impact analysis of solution options and assess/manage associated risks Conduct end-to-end business process analysis including integration with partner systems (ERP, shopfloor systems, automation layers), labelling technologies, and mobile technologies Stakeholder Management & Training Coordinate, inform, and ensure functional expertise in a matrix context Transfer know-how, experience, and best practices to sites Contribute to Digital skills development within your domain Provide functional & technical support during the full solution lifecycle and to the sites Ensure adoption and adequate use of solutions Deliver on-site training to manufacturing sites Delivery & Quality of Services Design and build MBRs, Process Instructions, blocks, and templates including Functional specifications Configure & implement core solutions as close to standard market solutions as possible, based on state-of-the-art best practices Aim to align processes and enable industrial efficiency across different Sanofi industrial sites Define appropriate design & build of solutions by adopting GxP validations Participate in regular design reviews with site modelers to ensure best practices are followed Perform or participate in regular MBR reviews for sites Ensure technical solutions comply with recommendations for Quality, Security, and Accessibility Lead the on-time delivery of projects while ensuring robust, cost-effective solutions Safeguard proper deployment of core solutions on different industrial sites Participate in defining indicators for performance and quality of service, monitor and communicate them Manage preventive/corrective maintenance for components Ensure standards and rules for Platform Management (Release management, Solution Documentation, Testing) are correctly understood and applied Manage incidents & corrective/preventive actions Strategy Development & Implementation Remain current on technology trends and benchmark with other companies and partners to bring innovative inputs to solutions, operating models, and strategy Collaborate with peers (Enterprise Architects, solution/ technical architects, Quality, Cybersecurity) to review and qualify solution design and/or introduction of new technology Explain/present architecture and technical matters in an understandable way to Digital management team, staff, and business stakeholders Break current GxP Validation established postulates to simplify and adapt to current and next-generation technologies & methodologies (Cloud, Service Management, Agile) About You Experience & Knowledge 8+ years of work experience in Digital for Manufacturing domain, with 5+ years of experience in MES, specifically Siemens OPCenter Execution Pharma and Siemens Equipment logbook Demonstrated experience in multicultural/multilanguage environments and matrixed organizations Broad knowledge of manufacturing processes in industrial plants Strong MES experience: market standards knowledge (solutions, technologies, integration, architecture), process industry within life science/pharmaceutical industries Experience & understanding of core product/model concept Successful and significant Project Management experience is a plus Technical Skills Expertise in MES solutions: Siemens OPCenter Execution Pharma and Siemens Equipment logbook Strong knowledge of Manufacturing Execution Systems, including Master Batch Record and Review by Exception business processes Solid understanding of manufacturing processes in pharmaceutical plants Strong knowledge of pharma industry regulatory context (GxP) Strong knowledge of Digital technologies & concepts Knowledge of Automation layer (SCADA, DCS, PLCs, industrial protocols) Good experience & knowledge of Mendix Knowledge of Scripting (VB/.Net) development & validation JSON development is a plus Knowledge of reporting tools (Power BI) is a plus Soft Skills Accountability and reliability Customer-driven mindset Fast learner, proactive, willing to apply change management Ability to deal with ambiguous situations Strong focus on value delivery, with ability to work autonomously on solution design Ownership and leadership within assigned scope Agile methodology practitioner Communication and interaction skills Ability to challenge, open-minded and active listening Ability to explain complex matters in a simple and understandable way Education Engineering degree or Master's in Computer Science or related field (or equivalent experience) Language Fluent in English, other languages are a plus Working Environment Travel requirement: 30% of time to manufacturing sites in Europe, North America & Asia Global, matrix organization environment Must be able to work effectively across different time zones and cultures Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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3.0 - 5.0 years

0 Lacs

Hyderābād

On-site

About the Job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process Deliver innovative "state of the art" tools enabling performance for manufacturing processes Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently Role Overview The MBR Developer is responsible for building, testing, and implementing Master Batch Records (MBRs) and related components within the Manufacturing Execution System (MES). You will ensure that MBR configurations align with the Core model and operational excellence standards while adhering to Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments. Working in close collaboration with MES Digital Product Configuration Manager, MES Digital Product Configuration Experts, MES Product Owner, MES installers/developers, Product lines, local digital teams, Business Process Owners, and Site modelers, you will contribute to the successful implementation of MES solutions across Sanofi manufacturing sites. Systems & Processes in Scope Main MES Systems: Siemens MES Opcenter Execution Pharma Product Siemens Equipment logbook Pharma Main platform : Mendix Business Processes Covered: Master data management (items, user rights, equipment, locations, work orders) Master batch record design & approval (including workflows) Master batch record review & approval (by Exception) Production execution Instructions for Operating Text Weighing & Dispensing Communication to equipment or SCADA systems Equipment management Material flow management Traceability / Genealogy Labelling Reporting Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE) Main Responsibilities Business Alignment Understand business requirements and contribute to building & testing solutions Support the implementation of appropriate services to ensure optimal allocation of available capabilities Contribute to end-to-end business process analysis including integration with partner systems Collaboration & Skills Development Contribute to Digital skills development within your domain Collaborate effectively in a matrix environment Delivery & Quality of Services Build and test MBRs, Process Instructions, blocks, and templates according to specifications provided by Digital Product Configuration Experts/ following established guidelines Develop and maintain test scripts for MBR validation Follow established build and test methodologies by adopting GxP validations Perform or participate in regular MBR reviews for sites Configure & implement core solutions as close to standard market solutions as possible Ensure solution builds are aligned with user requirements & core model Ensure technical solutions comply with recommendations for Quality, Security, and Accessibility Support the proper deployment of core solutions Ensure standards of Platform Management (Release, solution documentation, testing) are followed Contribute to the on-time delivery of projects Support impact analysis of configuration changes Troubleshoot and resolve technical issues during MBR implementation Document technical aspects of MBR configurations Support system testing and validation activities Support the Implementation of configuration changes following change control procedures Manage incidents & corrective/preventive actions Quality and Compliance Track and report on established KPIs for quality of service Ensure all configurations meet GMP requirements and data integrity standards Maintain configuration documentation in alignment with validation requirements About You Experience & Knowledge 3-5 years work experience in Digital Manufacturing/MES specifically on Siemens OPCenter Execution Pharma and Siemens Equipment logbook MES experience with relevant solutions/ modules/functionalities Experience working in multicultural/matrixed environments Experience & understanding of core product/model concept Experience working in industrial plants is preferred but not mandatory Technical Skills Knowledge of MES solutions: Siemens OPCenter Execution Pharma and Siemens Equipment logbook Knowledge of pharma industry regulatory context (GxP) Knowledge of Digital technologies & concepts Beginner knowledge/ experience on Mendix Knowledge of Automation layer (SCADA, DCS, PLCs) is a plus Knowledge of scripting (VB/.Net) and JSON is a plus Soft Skills Accountability and reliability Good mindset - quick learner, proactive, willing to apply change management Collaboration and good team player Ability to deal with ambiguous situations Focus on value delivery, with the ability to work on solution build and testing and proactiveness within the assigned scope Knowledge of Agile methodologies Education Engineering degree in Computer Science or related field Language Fluent in English, other languages are a plus Working Environment Travel requirement: Occasional travel to manufacturing sites Global, matrix organization environment Must be able to work effectively across different time zones and cultures Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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8.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

We are seeking an experienced Computer System Validation (CSV) Specialist to lead and support the validation of GxP-compliant systems used in manufacturing, laboratories, and quality assurance functions. The ideal candidate will possess strong domain knowledge in pharma operations, validation methodologies, and regulatory compliance, along with hands-on experience in validating systems like TrackWise, SAP, SCADA , and MES . Key Responsibilities: Develop and execute CSV lifecycle documentation : URS, Risk Assessment, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports. Ensure compliance with 21 CFR Part 11 , Annex 11 , GAMP 5 , and GxP guidelines. Manage validation of GxP-critical systems including LIMS, QMS, ERP, PLC/SCADA , and electronic batch record (EBR) platforms. Collaborate with cross-functional teams (QA, IT, Manufacturing, Lab) for smooth implementation and validation of computerized systems. Review and approve vendor-supplied documentation and software qualification deliverables. Participate in audits and inspections; ensure readiness of CSV documentation and responses to regulatory bodies. Maintain Change Control and Periodic Review activities for validated systems. Provide training to stakeholders on system validation procedures and compliance expectations. Required Qualifications: B.Pharm from a recognized university (M.Pharm or additional certifications in CSV is a plus). 5–8 years of relevant experience in Computer System Validation in a regulated pharmaceutical or life sciences environment. Strong working knowledge of LIMS , TrackWise , SAP , MES , or other pharma-grade software systems. Familiarity with data integrity principles , GAMP 5 guidelines, and risk-based validation approaches (CSA exposure is a plus). Good documentation practices and ability to work across cross-functional teams. Key Skills & Competencies: Expertise in CSV lifecycle and compliance frameworks Strong understanding of pharma shop floor and laboratory processes Risk assessment & validation planning Cross-functional communication and stakeholder management Audit preparedness and regulatory interaction experience

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4.0 - 6.0 years

2 - 6 Lacs

Ahmedabad

On-site

Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC ,Polarimeter , KF, Autotitratior e.t.c. Responsible for sampling, testing and release of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Skills and Proficiency: Analytical Instrumentation Handling – Expert Particulate Matter Testing – Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner Data Integrity & Documentation – Practitioner Regulatory Compliance – Practitioner SOP Preparation & Revision – Practitioner Analytical testing expertise and evaluation skills – Expert Handling of Analytical Instruments and Interpretation of Resulting Data – Practitioner Laboratory Instrument qualification, Calibration & Maintenance – Practitioner Quality Control & Compliance – Practitioner LIMS Operation & Data Management – Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) – Beginner CAPA, Deviation, and Change Control Management – Beginner Qualification : Bachelor or Master's degree in science Experience: Minimum 4 to 6 years of relevant experience in QCC Department Note: Candidate who want to apply for internal job posting must have completed atleast 2 years in his current job role.

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1.0 - 4.0 years

3 - 4 Lacs

Ahmedabad

On-site

Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC, Polarimeter , KF, Auto titrator e.t.c. Responsible for QCC-QMS Section regarding the test procedure, OOS, OOAL, Deviation, Change Control Note, Incident, Investigation Report Preparation e.t.c. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Responsible for QCC-QMS Section regarding the test procedure, OOS, OOAL, Deviation, Change Control Note, Incident , Investigation Report Preparation e.t.c. Skills and Proficiency: Analytical Instrumentation Handling – Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner Data Integrity & Documentation – Practitioner Regulatory Compliance – Practitioner SOP Preparation & Revision – Practitioner Handling of Analytical Instruments and Interpretation of Resulting Data – Practitioner Quality Control & Compliance – Practitioner LIMS Operation & Data Management – Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) – Beginner CAPA, Deviation, and Change Control Management – Beginner Experience: Minimum 1 to 4 years of relevant experience in QCC Department Note: Candidate who want to apply for internal job posting must have completed atleast 2 years in his current jobrole.

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12.0 years

4 - 7 Lacs

Jaipur

On-site

Role Definition: The Laboratory Director, heading the Center of Excellence (COE) in Laboratory Medicine, is responsible for the strategic and operational leadership of all laboratory medicine services, including Clinical Pathology, Hematology, and Biochemistry. The role ensures business enablement, diagnostic accuracy, quality assurance, operational efficiency, clinician engagement, and technical team development. It involves high-level expert consultation, end-to-end laboratory operations management, adherence to regulatory and NABL/ISO standards, and strategic collaboration with clinicians and healthcare providers to strengthen market leadership. Role Deliverables: Business Enablement – Drive scientific and commercial growth of laboratory medicine services. Diagnostic Accuracy & TAT Adherence – Ensure 100% accurate and clinically correlated reporting within committed turnaround times. Laboratory Operations Management – Oversee Central and Regional Labs for optimal efficiency, cost control, and resource management. Helpdesk Management – Ensure seamless resolution of clinician and branch queries with technical authority. Clinician Engagement & Scientific Consultation – Build scientific credibility and strengthen clinician partnerships. Quality Management & Compliance – Achieve and maintain NABL/ISO compliance with robust internal and external quality programs. People Leadership – Build, mentor, and lead high-performing technical teams with a strong performance and learning culture. Task and Activities: Business Enablement: Drive revenue growth through strategic business development initiatives. Collaborate with business teams to enhance partnerships with hospitals, clinics, and healthcare providers. Act as a medical advisor to key clinicians and healthcare institutions. Engage in scientific marketing, RTMs, CMEs, industry events, and expert consultation to expand diagnostic services. Provide high-level consultation to referring physicians and healthcare professionals to enhance patient management. Respond to technical queries, critical value discussions, and interpretation requests from doctors. Collaborate with business development to address technical queries from partner hospitals and doctors. Collaborate with Marketing for CME content, diagnostic bulletins, and clinician awareness programs. Assess the relevance and volume of current test panels; recommend test menu enhancements based on market and medical needs. Diagnostic Accuracy & TAT Adherence Monitor end-to-end sample workflows for Biochemistry, Hematology, Immunology, and Clinical Pathology. Personally validate critical reports and ensure proper clinical correlation before release. Conduct daily delta checks, histogram reviews, and trend analysis for critical parameters. Identify bottlenecks and ensure 99%+ TAT adherence, coordinating with logistics and operations teams Laboratory Operations Management: Implement the laboratory policies, procedures, and quality control protocols as aligned with the Medical Directorate. Oversee daily operations of Central and Regional Laboratories, ensuring efficiency, cost-effectiveness, and compliance. Ensure the accuracy of diagnostic tests and reports. Manage the laboratory resources, including equipment, reagents and other supplies. Manage the laboratory’s financials, including budgeting and cost control. Monitor financial performance indicators and implement corrective actions as needed Quality Management and Compliance: Conduct daily quality management practices across Central and Regional Laboratories to meet regulatory requirements. Ensure daily internal QC, EQAS, and LIMS-based control validations are completed and signed off. Manage the Internal audits and participate in external quality assurance programs to ensure compliance. Monitor delta checks, critical value communication, and compliance with QC protocols Implement corrective and preventive actions (CAPA) based on audit findings and quality assessments. Ensure SOPs, checklists, and dashboards are updated on real time basis. Coordinate with the QC Team to monitor and enhance quality control measures. Report quality indicators trends in monthly meetings and track improvements Helpdesk Management: Lead the Laboratory Helpdesk team and serve as the primary point of contact for resolving technical queries from branches and clinicians. Ensure seamless communication and issue resolution within defined SLAs. Manage escalations related to test results, patient concerns, and clinician inquiries. Develop and implement protocols to handle service-related complaints effectively. People Leadership: Recruit, train, and supervise technical teams. Set an individual role clarity, roster with each team member aligned with the laboratory objectives. Conduct daily huddles with the team to discuss ongoing activities and address any issues. Hold weekly meetings with the team to discuss operational performance indicators and lead measures. Conduct monthly 1:1 meetings with direct repartees to review progress on KPIs and plan the way ahead. Document and share feedback with each team member. Assess individual ASK (Attitude, Skills, Knowledge) on a quarterly basis and manage the learning of the team in collaboration with the HR team to enhance skills and drive career paths. Monthly recognize and reward high performance and initiate improvement plans where necessary. Achieve the People Score of 90. Success Metrics: 100% achievement of strategic goals (Revenue & Profitability) 100% accuracy rate in diagnostic tests and reports. 100% timely delivery of diagnostic results within established turnaround times 90% achievement of Quality indicators Adhere to a budget with no more than 2% variance. Customer feedback score of 4.8 or higher. Monthly RTM/ CME/ Clinician engagement activity as per calendar 100% compliance in NABL audits, IQC, EQAS Requirements :: D/DNB in Pathology, with additional training/fellowship in Hematopathology or Laboratory Medicine preferred. 12–15 years of post-MD experience, including 5+ years in leadership of multi-specialty diagnostic labs with NABL/ISO audit exposure. Proficiency in Clinical Pathology, Hematology, Biochemistry, LIMS, quality protocols (IQC/EQAS), and advanced diagnostic technologies. Strong clinician engagement, team mentoring, strategic decision-making, and business-aligned diagnostic leadership.

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3.0 years

0 Lacs

Hyderabad, Telangana, India

Remote

Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. Job Description 3 years’ experience managing software development teams in a distributed and global setup, including leadership of both internal and outsourced/offshore development teams 3+ Experience with multi-modal collaboration (in-office, hybrid and remote), and collaboration across time zones 5+ years of experience planning and delivering software projects within and across teams, including resource allocation and managing cross-functional dependencies. Ability to build clear and realistic project delivery plans 10+ years of software development 8+ years of programming experience in Java 5+ years of experience with HTML/CSS/JavaScript 5+ years of experience developing or using facing RESTful APIs Expertise in data modeling and developing schemas (relational databases, XML/JSON) Experience in developing LIMS Applications, such as LabVantage Experience with Amazon Web Services or similar cloud architectures Experience working in a fast-paced environment leveraging an agile development framework Qualifications B.S. or higher degree in computer science, engineering, or related areas Additional Information To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants . Please visit our career page at: http://www.guardanthealth.com/jobs/

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0.0 years

0 Lacs

Chennai, Tamil Nadu

Remote

Company Overview: ElizaLIMS is a cutting-edge healthtech company building next-generation Laboratory Information Management Systems (LIMS) to streamline operations, ensure compliance, and enable smart automation in analytical, clinical, and research laboratories. We are looking for a seasoned Device Interfacing Developer with deep expertise in integrating medical and laboratory instruments with LIMS platforms. Job Summary: We are looking for a Junior .NET Developer with basic experience in C# and interfacing laboratory instruments using Serial Port (RS232) , TCP/IP , and message formats like ASTM and HL7 . You’ll help develop and support communication modules that connect lab machines with our LIMS/LIS system. Responsibilities: Develop and maintain .NET apps for lab device communication. Interface with lab equipment over serial/TCP/IP. Parse/send ASTM and HL7 messages. Troubleshoot communication and log issues. Work closely with QA and support teams. Requirements: Proficiency in C# and .NET. Basic knowledge of RS232, TCP/IP communication. Understanding of HL7/ASTM message formats. Strong problem-solving and debugging skills. Degree in CS, IT, or related field. Nice to Have: Experience with HL7 libraries (e.g., NHapi). Familiarity with LIMS/LIS systems or lab workflows. If you are passionate about LIMS Device Interfacing development and eager to contribute to innovative projects, we encourage you to apply. Join us in creating exceptional digital experiences! Job Types: Full-time, Permanent, Fresher Benefits: Work from home Schedule: Day shift Evening shift Monday to Friday Morning shift Night shift Rotational shift Weekend availability Application Question(s): Do you have a personal laptop with a broadband connection? Location: Tamizhagam, Tamil Nadu (Required) Work Location: Remote

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0.0 years

0 Lacs

Salem, Tamil Nadu

On-site

Company Overview: ElizaLIMS is a cutting-edge healthtech company building next-generation Laboratory Information Management Systems (LIMS) to streamline operations, ensure compliance, and enable smart automation in analytical, clinical, and research laboratories. We are looking for a seasoned Device Interfacing Developer with deep expertise in integrating medical and laboratory instruments with LIMS platforms. Job Summary: We are looking for a Junior .NET Developer with basic experience in C# and interfacing laboratory instruments using Serial Port (RS232) , TCP/IP , and message formats like ASTM and HL7 . You’ll help develop and support communication modules that connect lab machines with our LIMS/LIS system. Responsibilities: Develop and maintain .NET apps for lab device communication. Interface with lab equipment over serial/TCP/IP. Parse/send ASTM and HL7 messages. Troubleshoot communication and log issues. Work closely with QA and support teams. Requirements: Proficiency in C# and .NET. Basic knowledge of RS232, TCP/IP communication. Understanding of HL7/ASTM message formats. Strong problem-solving and debugging skills. Degree in CS, IT, or related field. Nice to Have: Experience with HL7 libraries (e.g., NHapi). Familiarity with LIMS/LIS systems or lab workflows. If you are passionate about LIMS Device Interfacing development and eager to contribute to innovative projects, we encourage you to apply. Join us in creating exceptional digital experiences! Job Types: Full-time, Permanent, Fresher Schedule: Day shift Evening shift Monday to Friday Morning shift Night shift Rotational shift Weekend availability Application Question(s): Do you have a personal laptop with an internet connection? Are you ready to relocate to Salem, Tamil Nadu? Work Location: In person

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0.0 - 4.0 years

2 - 6 Lacs

Hyderabad

Work from Office

newmark is looking for Analyst 1 - Gerald Eve to join our dynamic team and embark on a rewarding career journeyCollect, analyze, and interpret data from various sources to support business decisions and strategy development.Prepare detailed reports, dashboards, and visualizations that highlight trends, patterns, and actionable insights.Collaborate with cross-functional teams to understand data requirements and deliver accurate analytical solutions.Use statistical methods and data modeling techniques to solve business problems and improve processes.Validate data integrity and ensure accuracy in all analyses and reports.Monitor key performance indicators (KPIs) and provide regular updates to management with recommendations.

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8.0 years

0 Lacs

Delhi, India

On-site

Senior QA Executive – MARS Cosmetics Location: Delhi (Head Office; ~25% travel to 3P plants across India) Employment Type: Full-time Function: Quality Assurance / Regulatory Seniority Level: Mid-Senior (5–8 yrs) About MARS Cosmetics MARS is a fast-growing , design-led Indian color cosmetics & personal care brand scaling toward global markets. All products are manufactured through qualified third-party (3P) partners; world-class quality is mission-critical. Role Mission Own end-to-end product quality across our 3P manufacturing network. Build and enforce gold-standard QA systems so every MARS batch is safe, compliant, high-performing, and consumer-delighting. Key Outcomes (First 12 Months) • Implement standardized QA agreements & GMP audit scorecards across 100% of 3P sites. • Reduce batch release cycle time to <24 hrs from complete documentation receipt. • Close 90% CAPA actions within agreed timelines; trend & report monthly. • Achieve >95% on-spec batch acceptance rate (rolling 6 months). Core Responsibilities • 3P Quality Governance – Draft, negotiate, and enforce quality & technical agreements; maintain approved vendor list. • GMP Audits & Compliance – Plan and conduct risk-based onsite audits (≥2/site/year); issue NC reports; drive CAPA closure. • Batch Release Control – Review COAs, in-process data, micro results, stability & packaging compatibility; authorize release/hold. • Specifications & Change Control – Maintain master product & packaging specs; manage deviations, reworks, relabeling approvals. • Regulatory Readiness – Ensure BIS registration, CDSCO compliance, labeling/claims checks; align with ISO 22716 & relevant global cosmetic regs. • Complaint & Deviation Management – Lead root-cause analysis (5-Why, Fishbone); trend recurring issues; feed prevention actions to R&D & Procurement. • Supplier / Material Qualification – Support onboarding of new formulas, actives, pigments, and packaging; conduct first-article & incoming QA checks. • Stability & Shelf-Life – Coordinate accelerated/real-time studies; track results against claims and storage conditions. • Documentation & QMS – Own SOPs, forms, logs, electronic records (ERP/LIMS); ensure data integrity & audit trails. • Cross-Functional Support – Partner with R&D, Packaging Dev, Ops, and Logistics on scale-ups, artwork, line trials, and recall readiness. Must-Have Qualifications • B.Pharm / B.Tech (Cosmetic Tech, Chemical Engg, Pharmacy, or related). • 5–8 years QA/QC experience in cosmetics, personal care, or FMCG with multi-site 3P / contract manufacturing exposure. • Working knowledge of ISO 22716 (Cosmetic GMP), BIS standards, stability & microbiological testing. • Strong documentation discipline; proficient with MS Office / Google Sheets; exposure to ERP / LIMS / eQMS tools. • Hands-on auditor comfortable in plants, labs, and with suppliers; willing to travel ~25%. Soft Skills That Matter • High ownership & follow-through in a fast, entrepreneurial environment. • Clear written documentation; confident cross-functional communicator. • Ability to negotiate quality expectations with external partners without damaging relationships. • Analytical mindset; comfortable with numbers, risk scoring, and prioritization.

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3.0 - 5.0 years

0 Lacs

Kolkata, West Bengal, India

Remote

Role Summary The Integration Engineer is responsible for designing, deploying, and supporting the integration software, integration routes and configuration required to integrate the Clinisys applications with the customer systems. The Integration Engineer role is part of the Professional Services Department. The Integration Engineer will use there HL7, Integration engine, and development knowledge to work in partnership with the customer to design, document, build and deploy the required workflows. The Integration Engineer role is customer facing, the Integration Engineer will be responsible for organising and managing customer meetings in person or remotely to agree the design, demonstrate function and train the customer. They will also be a point of contact for the customer. The Integration Engineer will maintain documentation to support the project, feedback to the project manager, raising risks and issues in a timely manner. The Integration Engineer will provide support for the Clinisys Service Desk, interacting with the Service Desk team members, owning incidents and resolving issues. The Integration Engineer will identify improvements and be actively involved in enhancing the solution and processes. To implement the Clinisys LIMS Solution by work discipline into Hospitals and Trusts within the UK as directed by the Domain Lead and the Project Manager to satisfy the customer and business requirements To act in a consultative role, with the customer, in configuring the Clinisys Software to enhance the workflow of the laboratory with Domain knowledge To be an instrumental element in the functional development of the Clinisys Products. Key Duties Project Delivery To understand our customers’ workflow, advise and assist with Clinisys products and configuration to facilitate these needs. Assist Project manager with the implementation, including calls with Trust or Customer IT representatives. Comprehend the Customers’ requirements as specified in the PID (Project Initiation Document) and the design document presented at the Sales stage Integration system Design, Build, Test, Validation in advance of Service Transition to Service Desk Support Project delivery through Sales handover to Go Live Support Deliver relevant courses for key users of pathology, as required. Assist with demonstrations and presentations for the Sales and Marketing team. Service Support – Including Integration Support, P1 escalation calls, 4th Line Review. Available for On-call support 24*7 as and when required. Development Contribute to the development of the Software product To develop interfaces to third party systems as part of Clinisys integration deployment To make recommendations based on customer feedback with regard to software changes and enhancements To progress personal development To be fully conversant with the functionality of the products of your discipline General To work with and follow the guidance of the Domain Lead for Integration To contribute to the team spirit within the company and to actively promote a customer-oriented approach. Perform other duties as required or assigned by the Domain Lead for Integration To actively advocate, initiate, and implement quality improvement measures/projects in conjunction with the Delivery leadership To keep abreast of ongoing and future Integration related regulations, working practices, products and technologies. To comply with the Clinisys codes of conduct and guidelines. To understand, comply and develop with customer and Clinisys procedures, working practices and directives in a timely manner. To be conversant with the core functionality of Clinisys products To attend team meetings and agreed training courses. To be responsive to reasonable requests from your line manager or project managers. Contribute to and support Clinisys team members and build knowledge base. Any other duties commensurate with grade. Form part of a collaborative review process for core WinPath or Clinisys product changes. Including, but not limited to: Raising and assessment of integration domain enhancements for current Products. Raising and assessment of integration domain defects for current Products. Review of appropriate specifications for current Products. Assessment and maintenance of Quality Assurance during Projects and Early Life Support. Attendance of integration domain-related Meetings to ensure: External market awareness. Continual Professional Development. Dissemination of new ideas and approaches. Presentations. Key Skills, Abilities And Experience Bachelor’s degree in computer science or related degree. Experience will be considered in lieu of degree. Rhapsody Associate Certification would be advantageous but not explicitly required to apply for this role. Expected to complete Rhapsody Associate certification upon successful onboarding with Clinisys Pvt. Ltd. Minimum of 3-5 years of integration experience Experience within an IT or software providers organisation or implementation. History of successful deployment and support of interfaces within the NHS is advantageous. Strong motivational skills with excellent verbal and written communication skills Excellent analytical, problem-solving skills: the ability to analyse and interpret data quickly and efficiently to resolve issues and/or design solutions. Experience of hosting technical meetings with clients, making decisions and problem-solving in real-time - Face-to-Face and remotely. Previous client support/service experience Experience of the following technologies preferable: JavaScript Java .Net Any equivalent combination of education and/or experience providing the knowledge/skills/abilities listed above may be substituted. HL7 knowledge – working with HL7 v2.3 – v.2.5, specifically ADT, ORU and ORM messages Integration with following interfaces: ADT/PAS, Order Comms, Results Networking skills – TCP/IP, Firewall knowledge and experience Experience in a healthcare related industry preferably in NHS (UK). FHIR Knowledge and interface implementation using APIs Shift Timings This is a permanent role comprising a five-day week with shifts to cover our core UK hours from Monday to Friday. For India these are UK shifts from 1:30 PM to 9:30 PM IST.

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8.0 years

4 - 8 Lacs

Hyderābād

On-site

About the job: We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi has recently embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions that will accelerate Manufacturing & Supply performance and help bring drugs and vaccines to patients faster, to improve health and save lives. As part of the Digital M&S Foundations organization, the data modeler designs, implements, and documents data architecture and data modeling solutions, which include the use of relational and dimensional databases. These solutions support Manufacturing and Supply Data and Analytical products and other business interests. What you will be doing: Be responsible for the development of the conceptual, logical, and physical data models in line with the architecture and platforms strategy Oversee and govern the expansion of existing data architecture and the optimization of data query performance via best practices. The candidate must be able to work independently and collaboratively with the M&S teams Demonstrate a strong expertise in one of the following functional business areas of M&S: Manufacturing, Quality or Supply Chain Main Responsibilities Design and implement business data models in line with data foundations strategy and standards Work with business and application/solution teams to understand requirements, build data flows, and develop conceptual/logical/physical data models Define and govern data modeling and design standards, tools, best practices, and related development for enterprise data models. Identify the architecture, infrastructure, and interfaces to data sources, tools supporting automated data loads, security concerns, and analytic models. Hands-on data modeling, design, configuration, and performance tuning Work proactively and independently to address project requirements and articulate issues/challenges to reduce project delivery risks. Skills Bachelor’s or master’s degree in computer/data engineer technical or related experience. 8+ years of hands-on relational, dimensional, and/or analytic experience, including 5+ years of hands-on experience with data from core manufacturing and supply chain systems such as SAP, Quality Management, LIMS, MES, Planning Experience hands-on programing in SQL Experience with data warehouse (Snowflake), data lake (AWS based), and enterprise big data platforms in a pharmaceutical company. Good knowledge of metadata management, data modeling, and related tools: Snowflake, Informatica, DBT Experience with Agile Good communication, and presentation skills Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. Pursue Progress . Discover Extraordinary . Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue Progress. And let’s discover Extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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1.0 years

1 - 1 Lacs

India

Remote

· Receipt of sample Data entry of sample receipt information, Sample review and its record preparation.-1 · Sample repacking wherever possible, coding and issue of sample through the software and or manually.-1 · Collection and data entry of various sample analysis information,-1 · Report preparation, making analysis report to be sent to customer through LIMS. Preparation of weekly, monthly progress report of samples receipt, analysis & out of specification.-1 Work Remotely No Job Types: Full-time, Permanent Pay: ₹10,000.00 - ₹15,000.00 per month Benefits: Health insurance Experience: Data entry: 1 year (Preferred) Work Location: In person

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0 years

1 - 3 Lacs

India

On-site

Job Title: LIMS Specialist (Short-Term Assignment – 2 Weeks) Location: Ambattur, Chennai Department: Laboratory IT / Quality Systems Duration: 2 Weeks Reporting to: Lab Manager / Quality Systems Head / IT Lead Job Summary: We are seeking a knowledgeable and proactive LIMS (Laboratory Information Management System) Specialist for a 2-week short-term assignment to support the setup, configuration, validation, training, and maintenance of our LIMS infrastructure. The candidate will work closely with the laboratory and global IT teams to ensure the system is fully functional, optimized, and compliant with operational and accreditation standards. Key Responsibilities:System Setup & Configuration Configure modules and LIMS functions such as procedures, templates, reports, worksheets, instrument mapping, user rights, currency, pricing, invoicing, and sample tracking. Configure buyer profiles, client projects, pricing lists, folder templates, and account setups for new users. Provide advanced configuration support to technical teams and global staff. Validation & Testing Conduct validation of LIMS modules and features to ensure compliance with operational, regulatory, and client-specific requirements. Perform scheme validation and participate in go-live readiness assessments. Ongoing Support & Maintenance Provide technical support to end users before, during, and after go-live. Troubleshoot issues and escalate complex problems to global application support or business teams. Perform test cycles after updates or patches and maintain security settings. Training & Documentation Conduct hands-on training sessions for end-users as needed. Document all system activities and configurations to meet quality and accreditation standards. Assessment & Continuous Improvement Evaluate the utilization level of the LIMS against set expectations. Raise corrective/preventive actions and follow up on resolution. Recommend system improvements and optimization opportunities. Qualifications & Experience: Bachelor's degree in Science, IT, or related field (preferred). Experience with laboratory operations, SOPs, and equipment. Familiarity with ISO 9001, ISO/IEC 17025, GLP, and quality systems. Prior exposure to LIMS systems (configuration, implementation, or support). Strong knowledge of Microsoft Office (Word, Excel, PowerPoint) and basic IT troubleshooting. Excellent communication skills in English (oral and written). Ability to work collaboratively with cross-functional and global teams. Job Type: Contractual / Temporary Contract length: 2 weeks Pay: ₹15,000.00 - ₹30,000.00 per month Application Question(s): Do you have prior hands-on experience with Laboratory Information Management Systems (LIMS)? Are you familiar with ISO/IEC 17025, ISO 9001, or GLP standards? Are you available to work full-time for a 2-week short-term engagement ? Work Location: In person

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