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5 - 10 years

2 - 6 Lacs

Hyderabad

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Scientific Business Analyst (Specialist) – ELN What you will do This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role maximises scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree with 6 - 8years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms. Good-to-Have Skills: Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business stakeholders Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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5 - 10 years

2 - 5 Lacs

Hyderabad

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Scientific Business Analyst (Specialist) – Biological Studies (LIMS) What you will do Let’s do this. Let’s change the world. In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality work from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 4 to 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree and 6 to 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Must-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS/ELN platforms such as Benchling, Revvity, IDBS, STARLIMS, Watson, LabVantage, etc. Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premises infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business collaborators Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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5 - 8 years

0 - 0 Lacs

Bengaluru

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Experience -5 to 8 Years Skill: Labware LIMS Developer (Migration Project Experience is mandatory) Location: Bangalore Candidate should hold a Bachelor's degree in a computer system, engineer or Technical graduation. 6+ years of working experience in Labware LIMS, Web Services (REST & SOAP). Proficient in all technical aspects of Interfaces development (SAP), LIMS Basics, preferably Labware LIMS, Subroutines, Instrument interfaces. Good knowledge on the Labware databases. Work on the backlogs, fixing the bugs, and working on the change requests. Work experience on the Labware Migration projects . Very good technical understanding and hands on experience with software development projects. Proficient in usage of processes such as change control, version control, release management, service management and the related tools like JIRA, HPSM, GEAR, source code repositories. Excellent knowledge of GMP in the context of electronic systems. Required Skills Labware LIMS,Web Services,Labware Migration Projects

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0 - 1 years

0 - 0 Lacs

Ganganagar, Rajasthan

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Business Development Executive/Sr. Executive/Asst. Manager/Manager Company Name Dr. B. Lal Clinical Laboratory Company Website Company details Dr. B. Lal Clinical Laboratory, established in 1991, has been at the forefront of providing exemplary Pathological and Diagnostic solutions. With a commitment to incorporating the finest infrastructural and technological advancements in the global health sector, we have become a distinguished preference over the past 34+ years. Our relentless passion for delivering top-quality services, coupled with the unwavering trust of doctors and patients, has positioned us as a leader in reputed pathology lab networks. Dr. B Lal Clinical Laboratory Pvt. Ltd. stands out as the only Pathology Lab Network with a remarkable presence of more than 130+ collection centers across Rajasthan. Our highly sophisticated Central Processing Laboratory, equipped with state-of-the-art technology, is complemented by ten regional laboratories strategically located in Kotputli, Bhilwara, Chittorgarh, Bikaner, Ajmer, Alwar, Sriganganagar, Jodhpur, Ahmedabad, Kota, Bharatpur, and Sikar. This expansive network enables us to provide prompt and efficient services to our valued customers. Location Jodhpur, SriGanganagar, Sikar, Alwar, Bikaner, Ahmedabad Mode of Working Work From Office Days of Working 6 Days a week Responsibilities Role Definition: The Business Development Specialist is responsible for driving growth by identifying and acquiring new customers within the zone. This role involves prospecting, customer profiling, building relationships, and promoting the organization's brand and services to achieve sales targets and market expansion goals Deliverables: 1. Market Research and Analysis 2. Customer Acquisition and Pipeline Development 3. Customer Relationship Management 4. Sales Process Management 5. Reporting and Performance Analysis Key Responsibilities: Prospecting and Customer Acquisition: 1. Conduct market research in the zone to identify industry trends, competition, potential customers, and growth opportunities. 2. Prospect potential customers from different channels - Clinicians, Corporate hospitals, SIS, Franchisee partners, Corporate Industry, etc. Reach out to a minimum of 200 new prospects each month. 3. Implement a field-level lead generation plan to build a pipeline of qualified leads. Generate at least 25 qualified leads per month. MSL Development and Management: 1. Develop and update an MSL of a minimum 150 potential customers every quarter for conversion, engagement and building brand visibility 2. Regular meeting with identified potential customers to nurture relationships and explore business opportunities. Conduct at least 10 meetings with potential customers every day. Customer Profiling and Needs Assessment: 1. Create profiling of potential customers to understand their needs, desires. Identify customer pain points and business challenges through needs assessment. 2. Segment the customer based on criteria of A, B, C, and D Customer to prioritize outreach efforts. Solution Offering: 1. Create and present the elevator pitch, tailored solutions, products and proposals that address customer needs and align with service offerings. 2. Collaborate with the Product and Centre of Excellence team to develop and manage scientific content and promotional materials for effective communication with customers. Communicate scientific literature detailing product features, benefits, and advantages to the target audience. 3. Handle objections and close deals in collaboration with Zonal Managers to ensure customer conversion. Account Management: 1. Schedule regular follow up visits with existing customers to review their needs, satisfaction levels, and any issues they may have. 2. Plan and execute business activities such as RTMs,CMEs, Product-led scientific seminars, and other community engagement based on business needs and objectives. Engage a minimum of 30% of MSL through such activities every quarter. Sales Process Management: 1. Manage the end-to-end sales process from lead generation to contract closure and post-sales follow-up. 2. Log all sales activities daily in the LIMS Sales module to track progress, update records, and analyze sales performance metrics. 3. Prepare reports and presentations on sales performance, sales funnel status, and market insights every month. Success Metrics: 1. Generate at least 25 qualified leads per month 2. Conduct a minimum of 10 meetings with potential customers daily 3. Achieve a 30% conversion rate on presented proposals 4. Achieve minimum 75% MSL productivity Role Requirements: 1. Bachelor’s degree in science or a related field. 2. Demonstrated track record of success in sales and key account management, particularly in the Healthcare sector. 3. Minimum 60% score in matriculation and higher secondary 4. Exceptional customer service skills, encompassing active listening, problem-solving, and interpersonal communication. Strong written and verbal communication skills Interview process Virtual Any other additional information Candidate Profile Looking for a rock star developer. Contributes appropriately to conversations Understands client-server architectures Flexible attitude, ability to perform under pressure A commitment to quality and a thorough approach to the work Strong English communication skills (written/oral) Ability to work in a dynamic, agile environment ATGS official Email anita@atgs.co.in ATGS SPOC Contact number 7406026370 Job Types: Full-time, Permanent Pay: ₹20,000.00 - ₹25,000.00 per month Benefits: Cell phone reimbursement Health insurance Leave encashment Paid sick time Paid time off Provident Fund Schedule: Day shift Supplemental Pay: Performance bonus Ability to commute/relocate: Sri Ganganagar, Rajasthan: Reliably commute or planning to relocate before starting work (Preferred) Experience: Medical sales: 1 year (Preferred) Location: Sri Ganganagar, Rajasthan (Preferred) Willingness to travel: 75% (Preferred) Work Location: In person Expected Start Date: 02/06/2025

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8 - 12 years

25 - 30 Lacs

Mumbai

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Job Title - Lead- SAP Quality Management (SAP QM) Experienced Required- 8-12 Years Role Description: This role shall support global supply chain business team n various areas such a Supply Chain, Logistics, Shipping, inventory Management, Production Supply and related processes The applicant should also have broad knowledge of SAP The applicant should have the ability to support advanced business functions, translate complex business requirements into solution designs, and build and implement systems and technical solutions for operations. Job Requirements: Around 8+ years of experience in the SAP supply chain focused on SAP ERP design, implementation (at least 3 end to end implementation project) and support Business Process Knowledge of topics viz. Quality Planning, Quality inspection, Quality Control, Quality certificates Quality Notifications Stability Studies, Batch Management etc. Experience of integrating SAP QM with External system 3PLs like MES, Trackwise, LIMS, Labware, Lab Vantage etc, and with other SAP modules, GXP and SOX requirements Experience as Solution Architect in the multiple programs of global scae Experience in Business Blue Printing, Design, Prototyping, Functional Analysis, Configuration, Gap Analysis, Conversion Migration Testing Training Cutover, Go-Live and Post Go-live Support activities, driving Business process workshops and Fit/GAP analysis Deep Knowledge and expertise in Quality Management BPML Good experience in Data migration process and ETL Tools Domain experience in Quality Management with S/4HANA certification (preferred). Experience in Deal Pricing Transformation Deal Estimations Should have experience of Change Management, Task Planning, Project Reporting, Resource Management, Process improvement, Supervising. Strong relationship building skills Job Responsibilities : Establish relationships with Supply Chain (primarily Logistics, Warehouse, Shipping but also other Operations functions and Quality) and super users globally. Lead the engagement efforts at different stages from Problem definition to diagnosis to solution design, development deployment, contribute to unit level Organizational initiatives Design, Build Optimize End to End SAP Quality Management Processes for customers enterprise. Collaborate with business users in Supply Chain Dept. and other departments when needed, to gain a deep understanding of their business processes and requirements. Design, develop and test system solutions to address business requirements, in alignment with the global solution template. Collaborate with business teams globally to gain a deep understanding of business processes, requirements and develop test the processes to address business requirements. Develop functional specifications for custom developments and collaborate with the development team to get those built and tested.

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5 - 8 years

0 Lacs

Kolkata, West Bengal, India

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At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting –Tech Consulting – Veeva SMR & LS Practice Lead – Senior Manager As part of our EY-Technology Consulting team, you will help the clients by understanding their business needs and translating their strategies into realities through innovation. You will be also responsible for building a 10-15 member Veeva LS Team in GDS, and run the practice As a Veeva SMR actively establish, maintain and strengthen internal and external relationships. In line with our commitment to digital transformation, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team, identify automation opportunities and drive internal initiatives. Your Key Responsibilities Client Responsibilities Participate and lead Veeva engagements in the area of GxP, Non-GxP and commercial.Responsible for building a 10-15 member Veeva LS Team in GDS, and run the practiceHelp manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leadersDrive-in business development initiatives along with client management and account managementBuild strong internal relationships within Technology Consulting practice and with other services across the organizationBuild connect with client stakeholders, understand their business challenges/pain areas and work with leadership to propose innovative solutions People Responsibilities Develop Veeva people/practice through effective coaching and mentoringConduct performance reviews and contribute to performance feedbackContribute to people-related initiatives including recruiting, retaining, appraisal and trainingContribute towards building and strengthening team competency for Veeva deployments including Business Process Analysis, Configurations and data migrationParticipate in the organization-wide people initiativesMaintain an educational program to develop veeva skills of team members continually Decision-Making Responsibilities: Support management in workforce planning, resourcing strategy, go to market strategy and demand generationUnderstand the business requirements clearly and lead practice development initiatives as requiredBring out of the box thinking mindset, and analytical thinking capability to enhance service deliveryAlways maintain connections with clients to tap opportunities for constant growth and improvementUnderstand the process gaps and propose preventive/corrective action where appropriateLead business growth, pursuits and client proposals for Veeva opportunities (RFPs and RFIs), directly working with the regional partners and Associate Directors. Other Responsibilities Actively contribute to the IT applications project management initiatives that includes project planning, risk assessment, business process analysis, test and data migration strategy as per GAMP Life Cycle approachIntegrate technology with business process transformation programs in quality and regulatory space covering Quality Management, Change Management, regulatory Information management, LIMS with Veeva suite of products like RIMS, QMS, Quality Docs, CTMS etc.Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagementSound understanding of the Veeva suite of products in GxP and commercial including integrations, configuration management, operational compliance, data migration etc.Identify opportunities in existing accounts to cross-sell other EY services.Planning and monitoring of the project deliverables from the team.Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelinesMaintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.Regular status reporting to the Associate Directors, Partners, Directors and onsite coordinators.Actively contribute to improving operational efficiency on projects & internal initiatives.Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.Demonstrate flexibility to travel to the customer locations on need basisConduct performance reviews and contribute to performance feedback for staff, senior and managersFoster teamwork, quality culture and lead by exampleUnderstand and follow workplace policies and proceduresTraining and mentoring of project resourcesParticipate in the organization-wide initiativesLead practice initiatives and portfoliosMarket trend +Digital trends.Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.Sound domain knowledge in Pharmaceutical industry along with Veeva products in the areas of Quality and ComplianceStrong knowledge of regulatory processes in clinical, laboratory and digital quality along with understanding of GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized SystemsStrong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.Strong Knowledge on Veeva products like Veeva QMS, Vault Quality Docs, RIMS, CTMS with key focus on OOB functionalities, custom configurations and data migration.Strong knowledge on Veeva custom configuration and migration techniques.Strong understanding of Data Integrity requirementsGovernance and reportingKnowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.Knowledge on operational compliance for Cloud Applications like Veeva.Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.Has supported Audits / Inspections To qualify for the role, you must have MBA/B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance/Life Sciences outsourcing companiesGood interpersonal skills; Good written and presentational skillsAt managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

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0 years

0 Lacs

Chennai, Tamil Nadu

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Pharmaceutical & Life Sciences Full-Time Job ID: DGC00268 Chennai, Tamil Nadu 2-5 Yrs ₹02 - ₹4.5 Yearly Job description 1. Analysis of rawmaterial, in-process, finished products stability samples of variousformulation products: oral solids, injectable ophthalmic products. 2. Handling of QCInstruments like HPLC, GC, UV, FTIR, pH Meter, etc. 3. Exposure onsoftware like Empowers, Labware LIMS. 4. Knowledge on theGLP GDP practices. 5. Execution ofvalidation, qualification and calibration activities in QC laboratory. 6. Preparation ofSOP, GTP, STP, specification, protocol, IOCP, record of analysis and analysisreports. 7. Handling, issuanceand maintenance of consumables, glasswares, chemicals, reference standards,working standards and cinematographic columns etc. 8. Preference tocandidates with exposure to regulatory audits like USFDA. 9. To review raw materials, in process, intermediate, finishedproducts, packing material, stability, Hold time samples, qualification,calibration AMT documents. 10. Investigation of OOS test results and laboratory incidences. 11. Ensure the compliance, Safety and 100% Good laboratoryPractices

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12 years

0 Lacs

Hyderabad, Telangana, India

Hybrid

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We are seeking a highly motivated and experienced Product Owner/Business Analyst/Subject Matter Expert to lead the development and enhancement of our Laboratory Information Management System (LIMS). This role will be responsible for defining and prioritizing product requirements, translating business needs into technical specifications, and ensuring the LIMS effectively supports our laboratory operations. The ideal candidate will possess a deep understanding of laboratory workflows, data management principles, and regulatory requirements within the [Specific Industry - e.g., Pharmaceutical, Biotech, Environmental Testing] industry. This is a hybrid role requiring a combination of product ownership, business analysis, and subject matter expertise. **Responsibilities:** * Define and maintain the product vision, strategy, and roadmap for the LIMS. * Prioritize and manage the product backlog, ensuring alignment with business goals and user needs. * Act as the primary point of contact for the LIMS product, representing the voice of the customer and stakeholders. * Collaborate with development teams to ensure successful product delivery. * Participate in sprint planning, daily stand-ups, sprint reviews, and retrospectives. * Translate business requirements into clear and concise user stories, acceptance criteria, and functional specifications. * Create process flows, use case diagrams, and other visual aids to communicate requirements effectively. * Conduct gap analysis to identify discrepancies between current and desired LIMS functionality. * Assist with user acceptance testing (UAT) and provide support to end-users * Serve as a subject matter expert on LIMS functionality, data management, and industry best practices. * Provide guidance and support to users on LIMS workflows and data entry procedures. * Stay up-to-date on industry trends and emerging technologies related to LIMS. * Participate in the evaluation and selection of new LIMS modules or enhancements. * Ensure the LIMS complies with relevant regulatory requirements, such as [e.g., FDA 21 CFR Part 11, GLP, GMP]. * Develop and deliver training materials and documentation for LIMS users. * Configure and customize the LIMS system to meet specific laboratory needs. Location-HyderabadExperience-12+years

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6 years

0 Lacs

Hyderabad, Telangana, India

Hybrid

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Job Title: Product Owner – ELN (Benchling)Experience-6years-12yearsLocation- HyderabadRole:Seeking a Product Owner with functional expertise in ELN platforms like Benchling, iLab, and Biovia. Should have experience working as a Business Analyst or Product Owner for ELN development or integration projects in Pharma or Life Sciences.Responsibilities:Define and manage the product vision, roadmap, and backlog for ELN solutions.Gather and prioritize requirements from R&D, lab users, and business stakeholders.Collaborate with technical teams to drive ELN development, customization, and integration.Ensure seamless interoperability of ELN with LIMS, CDS, SDMS, and other lab systems.Align ELN solutions with regulatory standards (GxP, ALCOA+) and industry best practices.Facilitate user adoption through training, documentation, and stakeholder engagement.

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7 - 12 years

15 - 25 Lacs

Hyderabad

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We are seeking a highly skilled and experienced Technical Architect/Developer to lead the design, development, and implementation of our Laboratory Information Management System (LIMS). This role will be responsible for ensuring the LIMS meets the needs of our scientific staff, integrates seamlessly with other laboratory instruments and systems, and complies with relevant regulatory requirements. The ideal candidate will possess deep technical expertise in LIMS architecture, software development, and data management, as well as a strong understanding of laboratory workflows and scientific principles. Responsibilities:** * Lead the design and architecture of the LIMS to meet current and future business needs. * Develop and maintain LIMS technical specifications, documentation, and standards. * Evaluate and recommend technologies and solutions for LIMS enhancements and integrations. * Ensure the LIMS architecture is scalable, secure, and maintainable. * Develop, test, and deploy LIMS customizations, extensions, and integrations. * Write clean, efficient, and well-documented code. * Configure and customize LIMS modules to meet specific laboratory workflows. * Perform data migration and data validation activities. * Troubleshoot and resolve technical issues related to the LIMS. * Design and implement integrations between the LIMS and other laboratory instruments, systems (e.g., ELN, CDS, ERP), and databases. * Develop and maintain APIs and web services for data exchange. * Work with vendors to ensure seamless integration of third-party software. * Provide technical support to LIMS users. * Monitor LIMS performance and identify areas for improvement. * Apply software patches and upgrades. * Participate in disaster recovery planning and testing

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8 - 12 years

12 - 17 Lacs

Mumbai, Chennai, Bengaluru

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The Strategy & Consulting Global Network Song Practice| Service | Life Science Manager (Level 7) Join our team of Strategy & Consulting Global Network Song who solve customer facing challenges at clients spanning Sales, Service and Marketing to accelerate business change. Practice: Strategy & Consulting Global Network Song I Areas of Work: Life Science, Service transformation, Contact Center, Platform Enablement viz. Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, etc | Level: Manager | Location: Bengaluru, Gurgaon, Mumbai, Chennai, Kolkata Hyderabad | Years of Exp:8 + years Explore an Exciting Career at Accenture Are you passionate about scaling businesses using in-depth frameworks and techniques to solve customer service challenges? Do you want to design, build and implement strategies to enhance business performance? Does working in an inclusive and collaborative environment spark your interest? Then, this is the right place for you! Welcome to a host of exciting global opportunities within Accenture's Strategy & Consulting Global Network Song practice. The Practice A Brief Sketch The Strategy & Consulting Global Network Song practice is aligned to the Global Network Song Practice of Accenture and works with clients across their marketing, sales and services functions. As part of the team, you will provide transformation services driven by key offerings like Service Transformation, Marketing Transformation, and Commerce and Sales. These services help our clients become living businesses by optimizing their marketing, sales and customer service strategy, thereby driving cost reduction, revenue enhancement, customer satisfaction and impacting front end business metrics in a positive manner. The Life Science Senior Manager position is within the Service practice of Accenture GN Song. The individual would work at the heart of the top global Pharmaceuticals, Biotechnology and Medical Technology organizations and would collaborate on innovative projects while bringing in deep industry knowledge to enhance Patient and HCP experience. You will work closely with our clients as Consulting Professionals who design, build and implement strategies that can help enhance business performance. As part of leading the project teams, you will drive the following: Consulting & Advisory service Lead a team responsible for designing, developing and implementing plans on delivering consulting services that improve service delivery, customer engagement, operational efficiency, and market success. Aid clients to adopt digital solutions to increase their competitiveness and accelerate GTM. Develop and implement solutions to address client challenges , such as improving patient outcomes, optimizing supply chain management, enhancing regulatory compliance, and accelerating product commercialization. Drive the adoption of technology capabilities while ensuring compliance with pharma industry regulations (e.g., HIPAA, GDPR, FDA, EMA) and data security standards. Assist Life Science clients with their most pressing service transformation problems by offering consulting and advisory services. Create a service transformational plan, close the gap between business and technology , and help clients achieve long-term success by co-creating future-proof, agile and resilient operating models. Develop and oversee Life Science components such as care management, patient journeys, appointment scheduling, and data integrations with other systems. Build and maintain client relationships , both existing and new, by understand client problems, bringing relevant solutions and offerings to the clients and influence improvement objectives Provide solutions to complex business problems /opportunities requiring in-depth knowledge of Patient and HCP dynamics, to optimize business processes and deliver on multi-channel customer service strategy. Data and Analytics driven approach highly essential powered by GenAI orchestration for identification and realization of value for the clients and help in driving measurable outcomes through digital investments at the right pace and scale. Recommend and implement digital solutions (e.g., automation, cloud platforms, AI and machine learning tools) to streamline operations and enhance service delivery. Sales & Business Development Generating new business engagements :Drive new business opportunities by identifying and pursuing new leads, defining GTM strategy, facilitate client discussions and presentations to drive new business and client relationships. Work as an integral part of the client's sales / channel development organization. Work towards driving sales and revenue numbers with a structured, logical and dataoriented approach, conducting Market Opportunity. Own and drive Service transformation RFP/RFI response coming in from Life science customers. Practice Development - Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Take on leadership role: Support overall growth of practice area through a combination of business development, talent management, oversight of delivery work, and thought leadership. Collaborate with Salesforce, Adobe, Nice, MS Dynamics, Genesys etc. business groups, to enable business capabilities with agility, velocity, and quality while optimizing costs. Lead and motivate teams with diverse skills and backgrounds. Manage and mentor talented teams of consultants and technologists supporting, providing input and guidance into the talent strategy and actively participate in engagement, capability development activities. Experience in working as an advisory lead in designing next gen service transformation solution on digital technologies like Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, Data automation and AI tools. Adept with working knowledge of Gen AI based technologies and tools such as ChatGPT, Gemini, DallE, Midjourney, Anthropic, Amazon Bedrock, LLama etc. Capable of using GenAI within applications such as Salesforce, Adobe and MS Dynamics. Understanding on healthcare delivery models, reimbursement systems (e.g., insurance, public health systems), and patient access programs. Bring your best skills forward to excel at the role: Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Expertise in patient-centric services, healthcare delivery systems, or operational models in life sciences. Deep understanding of Health Care processes, performance drivers & industry leading practices, regulatory and compliance requirements. Understanding of market access strategies for pharmaceuticals and medical devices, pricing and reimbursement, payer negotiation, health economics, and outcomes research (HEOR). Ability to develop long standing relationships with senior client stakeholders. Experienced in managing large global teams, multi-stakeholder environments and complex digital projects engagements in a global network. Strong program management/ people management skills. Experience working with "C" level executives. Problem solving and conflict management. Ability to work effectively in a remote, virtual and global environment. Read about us. What's in it for you? An opportunity to work on with key G2000 clients Potential to with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed into everything"from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions " underpinned by the world's largest delivery network " Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 624,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at About Accenture Strategy & Consulting: Accenture Strategy shapes our clients' future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers Song | At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, . Qualifications Your experience counts! Minimum 8+ years of relevant experience in Life science industry with good analytical skills along with domain experience. Working knowledge of Veeva CRM or Salesforce Health cloud and AI tools. Implementation experience is a plus. Demonstrated sustained client relations management experience at a C-suite level or operated at a senior management level in the industry role. Familiarity with healthcare technologies such as CRM, Electronic Health Records (EHR), Laboratory Information Management Systems (LIMS), and patient management platforms. Knowledge of allied service transformation capabilities such as speech analytics, workforce management, CX, etc. is a plus. Travel may be required for this role. The amount of travel will vary from 25% to 100% depending on business need and client requirements.

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3 - 8 years

3 - 8 Lacs

Ahmedabad

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Role & responsibilities Candidate having experience in to OSD pharmaceuticals from QC/QA/Production/F&D/ADL

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10 - 15 years

22 - 37 Lacs

Hyderabad

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Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contractual framework. As a visionary leader, you will inspire and guide our team of experts to deliver high-quality and reliable information technology services. Working closely with the latest systems, software products, and networked devices, you will align our solutions perfectly with our customers' evolving business needs. Your deep knowledge of the services we provide paired with your understanding of customer businesses, will enable you to propose and implement tailored solutions that exceed their expectations. You will be an integrated part of our customer account structure, fostering strong relationships with our customers and collaborating closely with our Delivery Partner & Customer Partner. Together, you will create an environment that promotes innovation, collaboration, and customer success. By owning the technical and managerial support for our plant IT team, field engineers, technicians, system administrators, subject matter experts, and product support personnel, you will empower them to deliver, manage, maintain, and deploy IT services effectively. When troubleshooting incidents, problems, changes, and escalations, you will be at the forefront, providing swift support to fix any issues that may arise in malfunctioning services, operations, software, or equipment. Your expertise will ensure that our systems run smoothly, offering our customers a seamless experience. As a plant operations Lead, you will have the unique opportunity to collaborate with an exceptional team of Delivery Partners, Architects, and SREs (Site Reliability Engineers). You will co-create, design, deploy, and maintain reliable, available, and future-proof systems and services. Your innovative ideas and leadership skills will play a vital role in shaping the technological landscape of our organization and the industry as a whole. If you are ready to make an impact, drive customer success, and be at the forefront of technological advancements, this is the role for you. Join our team and be part of an exhilarating journey as we reshape the IT services landscape with creativity, passion, and excellence. Your Future at Kyndryl Kyndryl has a global footprint, which means that as a Delivery Management Lead at Kyndryl you will have opportunities to work on projects and collaborate with colleagues from around the world. This role is dynamic and influential – offering a wide range of professional and personal growth opportunities that you won’t find anywhere else. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Skills and Experience Over 12 years of experience leading delivery teams and providing quality services to customers. Pervious experience in working with Pharma will be advantageous Strong understanding of Kyndryl competencies, managed platforms, IT services, and technology vendors. Strong understanding and knowledge of Pharam Plant IT Operations Oversee the day-to-day operations of IT infrastructure, network, applications, and support services. Ensure high availability and performance of critical systems including MES, LIMS, ERP, and SCADA. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5, GxP). Collaborate with QA/Compliance teams to support audits and inspections. Maintain cybersecurity posture in line with corporate standards and industry best practices. Lead and mentor a team of IT professionals and support staff. Manage IT budgets, contracts, and vendor relationships. Work closely with cross-functional teams including manufacturing, QA/QC, engineering, and supply chain. Experienced in leading teams through incident, problem, and change management, as well as root cause analysis. Capable of partnering with Delivery Partners and collaborating with SREs to achieve positive customer outcomes. Hands-on knowledge of AIOps with an automation and innovation-focused mindset. Proficient in maintaining direct and ongoing interaction with customers. • Compassionate and empowering delivery resource manager, promoting growth Knowledge of IT/OT systems, industrial networking, and cybersecurity in manufacturing. Preferred Skills and Experience •Bachelor's degree •Six Sigma, PMP, and/or ITIL certifications Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

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0 years

0 - 0 Lacs

Madipakkam, Chennai, Tamil Nadu

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Job Overview As a Laboratory Technician, you will play a crucial role in supporting the research and development activities within the laboratory setting. You will be responsible for conducting various experiments, analyzing data, and ensuring compliance with regulatory standards. Responsibilities Perform laboratory tests and experiments following standard procedures Maintain accurate records of all tests conducted and results obtained Operate and maintain laboratory equipment Assist in the development and implementation of research projects Ensure compliance with FDA regulations, GLP, and CGMP standards Conduct histology procedures as needed Collaborate with other team members to achieve project goals Experience Experience working in a research laboratory environment Familiarity with Laboratory Information Management Systems (LIMS) Knowledge of microbiology and animal physiology Understanding of FDA regulations and compliance standards Proficiency in histology techniques is a plus Job Type: Full-time Pay: ₹15,000.00 - ₹18,000.00 per month Schedule: Day shift Work Location: In person

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4 - 6 years

0 Lacs

Indore, Madhya Pradesh, India

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Job:- Lab Data Analyst positionsLocation:- Remote Experience:-4-6 yearscompany name : MAIG InnovationsEmployment type : contract( 1 years) Experience with laboratory systems like LIMS / CTMS and FDA regulations like 21 CFR Part 11. Ability to understand IRF’s and configuring it into one or more laboratory computer systems like ULTRA. 4+ years of experience in laboratory data management and Lab system Validation . Acts as expert to liase with IT and other teams to ensure appropriate functionality across systems. Sound knowledge of test code validation / end to end Validation between the LIS and Reporting systems. Sound Knowledge of Corepoint / Ability to read HL7 messages. Good computer skills including proficiency with Microsoft Excel and Word. Excellent oral and written communication skills. Strong analytical skills and close attention to detail are essential. Capable of handling multiple tasks simultaneously and independently. Ability to maintain a degree of independence to complete assigned tasks and projects. Ability to synthesize information from various topics. Ability to bring projects and deliverables to completion under timeline expectations and manage priorities . Experience in some of these Lab systems - ULTRA/ LIS LIMS Corepoint

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4 - 9 years

5 - 12 Lacs

Jamnagar, Gujarat, India

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Skills: Analytical Method Development, Regulatory Compliance (e.g., FDA, EPA), Sample Testing, Quality Systems, Calibration, Chemist, Job Accountabilities Support shift in charge for shift co-ordination work.Priorities the samples for testing.Provide right containers to collect samples, identifies right carriers to distribute samples and designate right location for pre-testing storage.Ensure the usability of the chemicals / standards to use in the test and performs the test by following the procedure step by step. Confirms test results by using validation techniques before reporting.Calibration - Identify the calibrations as per the method protocol and the instruments as per schedule. Prepare calibration and working standards as per requirement. Perform the calibrations as per the method and instrument as per schedule. Standardizes the laboratory solutions.Evaluates performance of additives and process chemicals.Collects samples of raw materials as per the requirement and track the quality of incoming raw material.Timely testing and results reporting of Raw materials, in process, product & trouble shooting samples of all plants.Classify the product grades based on the specification.Detect exceptions or deviations in test resultsPerform on-spot mitigation in emergency situation under the guidance of the section headEnsure proper sample retention as per defined lab procedure for addressing issues with customers (need based)Dispose left over samples safely as per SOP and co-ordinate with plant and other agencies for further actions.Awareness about Laboratory Quality Systems requirements and good knowledge and skills for LIMS and SAP QM operations for day to day laboratory work.Maintain laboratory inventory (Reagents, Glassware, and Equipment) and raise the requirement for its availability in time.Participate in various audits of lab quality systems including safety.Data ManagementComply to quality systemsEnsure timely entry approval of test results in LIMS.HSE & other regulatory complianceStay aware of environmental, site, statutory regulations.Handle chemicals and tools as per safety normsEnsure Good Housekeeping and safe working conditionsFollow and enforce applicable HSE procedures/ practicesLearning & mentoringConduct on job training to analysts and new joiners for laboratory analytical work.Business / Function-specific Competencies (Technical /Functional)Participate in external trainings and events as advised by the section headTimely execution of assigned tasksErratic changes in plansWorking with multiple interface such as business, customers, operations, E&M and HSEFSample managementPrioritization of assigned activitiesHSEF -specific CompetenciesFire Safety ManagementFire & Gas Detection systemWaste ManagementIntegrated Management SystemRIL HSE Management SystemHSE Policy, Principles, Standards and Procedures & PracticesEmergency Preparedness and response Skills Statistical Skill required assessing the reliability of test results.Relevant knowledge of the test procedure and results reporting as per standard method requirement.Knowledge of Raw Material, in process samples & finished product specifications and analysis as per contractual & domestic specifications.Competency to operate specific equipment, perform test, calibrations and evaluate results.Knowledge of significance of test parameters including safety in laboratory. Education & Experience : B. Sc. Chemistry, Masters preferred. Minimum 4-9 years in QA/QC discipline

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3 - 8 years

5 - 15 Lacs

Bengaluru

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Business Analyst – We are looking for 4- 5 BAs with 3 to 5 years of experience as a Business Analyst who have worked with LabVantage LIMS. Candidates must be proficient in speaking Japanese.

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0 - 2 years

0 Lacs

Ahmedabad, Gujarat

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Department ALIDAC QA Job posted on May 12, 2025 Employment type P-P7-Probationer-HO Staff ZTMP – REQUEST FORMAT Name : Garima Jha BU : Quality Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad. Contact # : 9173639189 Email Id : Garima.G.Jha@ZydusLife.com Basic Details: Position : Senior Executive Designation : Senior Executive Reports to : Deputy Manager Department : Quality Assurance Location : ZLL-SEZ Oncology Injectable (Alidac) No of Posts : 1 Role : Critical Neev Level : 1 Details : Replacement Position code : 60056568 Position Name : Senior Executive Key Job Description: (Not more than 5 points in 6 lines) Lab QA Role - To review Raw Material, Packaging Material, In-process, Finished product, shelf life specification and its relevant Method of analysis and authorize the Testing work sheet. To review and approved analytical data of Raw material, Packaging material, In-process, Finished product, Stability study and Consumable materials in LIMS. To ensure the compliance and routine checks of current Good Laboratory Practices in the Quality Control department. To review chemical and microbiological analytical method validation, method transfer and Verification protocol and report. Handling, storage, withdrawal and reconciliation of stability samples in LIMS or out of LIMS. To review analytical data and trend summary reports of stability studies. To verify the outside laboratory samples and it’s reports. To ensure and review Change control, Deviation, LIR, OOS, OOT, OOC, CAPA, Trends and other investigations of quality control and quality assurance department. To initiate the departmental change control, deviation, CAPA, BDIF and investigation report. To review the qualification and calibration documents of QC instruments/equipment’s. To review stability protocol and approved the schedule related to quality control department. To prepare and review, stability schedule, other study protocol and their reports as per requirements. To prepare and review the qualification/validation documents related to quality assurance. To review the audit trial of the QC instrument or equipment, Stability chambers/incubators. Temperature and humidity data recording, review and approved for stability chambers/incubators and respective rooms. To participate in regulatory audit and its compliance. Notify event of QMS to customer and compliance team, response to their query/comments. Handling and trending of Oversight observation and its compliance. To provide the Quality index and Quality Management review data. To ensure calibration, Qualification and Preventive maintenance of incubators and chambers as per schedule. To ensure and review the Alarm logs, alarm acknowledgement, alarm trending and alarm assessment. To review Critical Quality Attributes trend data. To review the protocol, analytical data and report for in vitro Bioequivalence studies. To receive, store, control, reconcile, retain and destroy Investigational products for in vitro Bioequivalence studies. Review and approved the data in LIMS (Laboratory Information Management System). Requirements: Qualification : B.Sc./M.Sc./B.Pharm/M.Pharm Years of Experience : 5 to 10 years Experience in Zydus : 2 years Experience / Exposure in (2 points) : Must have knowledge and experience in injectable plant. Mail your CVs to: Garima.G.Jha@ZydusLife.com/HardikA.Bhatt@ZydusLife.com

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1 years

0 Lacs

Bengaluru, Karnataka

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About us At ExxonMobil, our vision is to lead in energy innovations that advance modern living and a net-zero future. As one of the world’s largest publicly traded energy and chemical companies, we are powered by a unique and diverse workforce fueled by the pride in what we do and what we stand for. The success of our Upstream, Product Solutions and Low Carbon Solutions businesses is the result of the talent, curiosity and drive of our people. They bring solutions every day to optimize our strategy in energy, chemicals, lubricants and lower-emissions technologies. We invite you to bring your ideas to ExxonMobil to help create sustainable solutions that improve quality of life and meet society’s evolving needs. Learn more about our What and our Why and how we can work together . ExxonMobil’s affiliates in India ExxonMobil’s affiliates have offices in India in Bengaluru, Mumbai and the National Capital Region. ExxonMobil’s affiliates in India supporting the Product Solutions business engage in the marketing, sales and distribution of performance as well as specialty products across chemicals and lubricants businesses. The India planning teams are also embedded with global business units for business planning and analytics. ExxonMobil’s LNG affiliate in India supporting the upstream business provides consultant services for other ExxonMobil upstream affiliates and conducts LNG market-development activities. The Global Business Center - Technology Center provides a range of technical and business support services for ExxonMobil’s operations around the globe. ExxonMobil strives to make a positive contribution to the communities where we operate and its affiliates support a range of education, health and community-building programs in India. Read more about our Corporate Responsibility Framework. To know more about ExxonMobil in India, visit ExxonMobil India and the Energy Factor India. What role you will play in our team Research technologist (RT) for film application works in collaboration with internal customers in the areas of film applications for both Polyethylene & Poly propylene. RT is responsible to conduct laboratory testing activities in conformance to international standards, ExxonMobil in house methods to help business to create value of ExxonMobil's performance product in the market. What you will do Operate in highest ethical manner in compliance to ExxonMobil's safety, control, quality expectations Conduct laboratory testing activities as per international standards / ExxonMobil's in house methods Maintain laboratory testing equipment’s in healthy state by managing routine calibration, maintenance or other quality control parameters. Collaborate within team, cross functional team, demonstrate GI behaviors Demonstrate ownership, add value to business through the data generated. About you Skills and Qualifications Bachelor of Engineering - Polymer /Plastics engineering, Chemical engineering, Mechanical engineering with minimum 6.5 CGPA and above. Minimum 1 year of experience in laboratory activities - Testing, calibration, maintenance & use of laboratory management tools ( example: LIMS) Experience in the field of Polymers - Testing, manufacturing, packaging development, polymer processing Experience in laboratory operations - ASTM, ISO standards Preferred Qualifications/Experience Hands on experience in laboratory activities - Testing, calibration, maintenance & use of laboratory management tools (example: LIMS) Experience in polymer processing techniques - Injection molding, blow molding, blown film, general extrusion is an added advantage Knowledge on flexible packaging applications, choice of materials, attributes Able to work on fixed, flexible hours, open to travel occasionally. Your benefits An ExxonMobil career is one designed to last. Our commitment to you runs deep: our employees grow personally and professionally, with benefits built on our core categories of health, security, finance and life. We offer you: Competitive compensation Medical plans, maternity leave and benefits, life, accidental death and dismemberment benefits Retirement benefits Global networking & cross-functional opportunities Annual vacations & holidays Day care assistance program Training and development program Tuition assistance program Workplace flexibility policy Relocation program Transportation facility Please note benefits may change from time to time without notice, subject to applicable laws. The benefits programs are based on the Company’s eligibility guidelines. Stay connected with us Learn more about ExxonMobil in India, visit ExxonMobil India and Energy Factor India. Follow us on LinkedIn and Instagram Like us on Facebook Subscribe our channel at YouTube EEO Statement ExxonMobil is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin or disability status. Business solicitation and recruiting scams ExxonMobil does not use recruiting or placement agencies that charge candidates an advance fee of any kind (e.g., placement fees, immigration processing fees, etc.). Follow the LINK to understand more about recruitment scams in the name of ExxonMobil. Nothing herein is intended to override the corporate separateness of local entities. Working relationships discussed herein do not necessarily represent a reporting connection, but may reflect a functional guidance, stewardship, or service relationship. Exxon Mobil Corporation has numerous affiliates, many with names that include ExxonMobil, Exxon, Esso and Mobil. For convenience and simplicity, those terms and terms like corporation, company, our, we and its are sometimes used as abbreviated references to specific affiliates or affiliate groups. Abbreviated references describing global or regional operational organizations and global or regional business lines are also sometimes used for convenience and simplicity. Similarly, ExxonMobil has business relationships with thousands of customers, suppliers, governments, and others. For convenience and simplicity, words like venture, joint venture, partnership, co-venturer, and partner are used to indicate business relationships involving common activities and interests, and those words may not indicate precise legal relationships.

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15 - 20 years

75 - 80 Lacs

Baska, Halol

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QA will lead and oversee the entire QA function manufacturing facility,includes both General Injectable and General OSD units. ensuring compliance, USFDA, ensuring compliance to cGMP, cross-functional collaboration quality-driven site operations. Required Candidate profile Site Quality Leadership, Compliance Management, (QMS) Ownership, Cross-functional Collaboration, Batch Release and Product Quality Oversight, Training and Development, Qualifications & Validations

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2 - 3 years

0 Lacs

Kolkata, West Bengal, India

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Company DescriptionLabVantage Solutions, Inc., headquartered in Somerset, NJ with offices around the world, provides laboratories with a comprehensive portfolio of informatics products and services, including LIMS (Laboratory Information Management System), integrated electronic laboratory notebooks (ELN), and business intelligence. With over 35 years of experience in laboratory informatics, LabVantage leverages state-of-the-art technology to optimize laboratory operations. The company has a strong track record in delivering return on investment through legacy system migration, global laboratory harmonization, and laboratory business intelligence. For more information, please visit LabVantage Solutions. Role Description• Gather, develop, and document functional business requirements for customer projects. Transform the users’ requirements in to functional requirements leveraging the both the Sapphire architecture and functionality.• Interfacing with Configuration Designer and, if necessary, Applications Programmer to ensure the functional requirements and solutions are properly transferred for configuration / development. Review project construction efforts / development.• Interface with Project Management to insure strong communication regarding timelines, deliveries, project issues and changes are addressed.• Provide assistance and guidance to the customer in adding master data to the configuration prior to or during the implementation.• Administrative responsibilities.• Business Analyst responsibilities include the following: This is not an exhaustive task list and other duties may be assigned as deemed appropriate or warranted by immediate manager.• Generate consulting revenue coupled with the requirements of ensuring that each system configuration is delivered with a high degree of quality and within the required time frame.• Developing and implementing appropriate methods for capturing and documenting customer business requirements for system development, third party software integration and external database interfaces.• Conducting and facilitating customer workshops for information gathering.• Collaborating with Application Designer and Application Programmers to implement customer’s solutions.• Preparation of functional requirements specification (FRS).• Ensure that proposed FRS and corresponding design is line with the number of consulting days that have been ordered by the customer for this engagement.• Collaborating with Project Management on project issues, concerns, schedules of deliveries and completion estimates.• Provide day-to-day contact for the customer during the implementation.• Orchestrate system reviews and gather feedback from the customer on required changes• Provide input to the Project Manager on any change orders that may be requested by the customer• Execute the Acceptance Test Plan (ATP) with the customer, and document all exceptions, and coordinate a resolution plan with the designer/application programmers.• Work with the Project Manager to ensure that the developed configuration is handed off to the LabVantage support team. Qualifications• Business Analyst must have at least a Bachelor's degree, 3-5 years of experience interfacing with customers in a consulting environment• 2-3 years of experience in performing business analysis and/or process re-engineering• Must possess strong technical documentation and organizational skills.• Designed by Elegant Themes | Powered by WordPress

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2 - 5 years

0 Lacs

Mumbai, Maharashtra, India

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Job Description Delivers scientific/technical expertise to help drive sales and provide support for new and existing customers. Provides expertise during various phases of the sales process including pre-sales technical and application support for the sales team, which may include customer requirements analysis, sample analysis and/or feature-by-feature customer demonstrations, preparing and presenting technical presentations and seminars to potential customers, benchmarks, competitive positioning, and implementation/execution of solution/application. Understands customer’s problems, recommends solutions to meet their needs, and ensures customer satisfaction. Integrates Agilent products, applications and/or solutions into customer’s environment. Ensures the product/application functions per specifications. Provides remote and on-site troubleshooting. Maintains close alignment with sales partners, management, R&D and product marketing to communicate customer feedback. Ensures post-sales applications support inquiries and complaints are documented and logged according to regulatory and quality policies. May present information at conferences, seminars and e-seminars. Based on the business needs, a delivery engineer may act as a project manager or technical leader for specific projects. Presales: Engaging with sales for requirement analysis, scoping delivery, and early customer discussions. Post-sales: Project management and technical delivery of OpenLab solutions, early engagement for SLIMS solution delivery. Post-delivery: Advanced technical support for SMA customers' critical escalations. Qualifications Bachelor's or Master's Degree or equivalent. Post-graduate, certification and/or license may be required. Typically, at least 5+ years relevant experience for entry into this levelEvidence of proven track record of solution delivery on Implementation team, or related experienceAbility to quickly grasp customer requirements and document the requirementsOutstanding communication and organizational skillsExcellent analytical, and problem-solving skillsAbility to build and foster good relationshipsAbility to balance competing prioritiesAbility to work under pressure and meet tight deadlinesSelf-motivated and directed individualTeam-oriented perspectiveWillingness to travel 70% of the time, for business requirements and client meetingsEarly understanding on OpenLab solutions, SLIMS would be added advantageExperience on CDS, LIMS and project management would be an added advantage to have Additional Details This job has a full time weekly schedule. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws. Travel Required: 75% of the Time Shift: Day Duration: No End Date Job Function: Services & Support

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5 - 10 years

7 - 17 Lacs

Hyderabad, Chennai, Bengaluru

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Greetings from HCL! Currently Hiring for "Labware LIMS" JD: layers of application: DB, Application Servers, J2EE servers, understanding VDI dependencies) Labware inter-connectivity : DB, App servers, External SAP interfaces etc. Labware roles and their location in the system Oracle SQL queries Understanding Active Directory concept and how it connects to Labware Labware LIMS, Labware eLN, Labware Mobile Labware application servers and prerequisites Labware modules Labware packages allowing to debug code, write a simple code understanding LEM and value it might bring to the setup Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with updated resume Candidate Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

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3 - 6 years

6 - 9 Lacs

Bengaluru

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At Syngene, Safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards always Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Performing analytical method validations and related documentation, as well as analysis of RM, PM, Intermediates, API, and Finished products. Key Responsibilities: Performing Chromatographic and Non-chromatographic analysis for Drug substances, Drug products, Intermediates, Excipients, etc ). Conduct the analysis on qualified techniques per the approved specification / protocol / procedures , interpret the data from analytical instruments, report the results, and promptly submit the completed documents for review within the established window. Recording of analytical observations/findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS, and ELN application software, and support in preparing stability summary reports and review of final documents. Responsible for timely intimation/investigation of any events or deviations to the Department Head, QA function, supporting the related investigations to the clients, and timely closure. Instrument calibration as per schedule, hot water flushing of HPLC, and general preventive checks for laboratory instruments. Perform validation activities and method transfers for multiple client projects. Actively participate in client and regulatory audits. Ensure to follow cGMP and GDP. Preparing the certificate of analysis for standards and impurities and Reports for Analytical Method Validation and Analytical Method Transfer. Support in performing Qualification and Calibration of assigned Instruments and Equipment. Create/prepare documents, master data, and static data in LIMS, ELN, and LMS software as applicable. Outsourcing of sample testing is based on requirements and updating in respective logbooks. Coordination with engineering & maintenance and external vendors for preventive maintenance and calibration activity. Support in preparation of instruments URS, DQ, and IOP. Supported preparing standard operating procedures and uploading data in LIMS and other relevant activities per departmental requirements. Use of required safety PPE while sampling, analyzing, and working in the Laboratory. Individuals working in the GMP environment are responsible for documenting/recording the activities contemporaneously and accurately as per good documentation practices. Ensure safety compliance as per Syngene policy and EHSS requirements. Taking any other jobs by the Head QC/Group Leader/Designee. To ensure safety compliance as per Syngene policy and EHSS requirements. Educational Qualification: M Sc / M Pharma (Analytical/General chemistry) Technical/Functional Skills: Should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc... Being well-versed in the Chromeleon data management application and LIMS will be advantageous. Experience: 3- 6 years

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6 - 11 years

7 - 9 Lacs

Bharuch, Jhagadia, Ankleshwar

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Creation and Maintain relevant master data in the LIMS, Ensure that the integrity, reliability and performance of the LIMS is maintained. Address and resolve issues arising with the system in a timely manner Required Candidate profile Ready to work in Morning or General Shift To manage the QMS processes—including OOS investigations, Deviations, Incidents & Change Control & to ensure strict adherence to GDP & GMP within lab

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