488 Lims Jobs - Page 19

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation for pharma or medical devices and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers and Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in pharmaceutical industry in the areas of Quality Management System - Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix, Data Migration strategy and report etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written, oral and presentation skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA), ISO 13485:2016 – Medical Devices – Quality Management System Information Security (ISO 27001) or Risk Management certifications What we look for A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you

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.

Job Title LIMS Responsibilities At least 4-8 years of experience in LIMS(LV/LW) – Implementation /Configuration/Customization using Java, Java script. integration with Lab applications, and should have implemented at least 2-3 projects with role involving development using LabVantage platform and Jasper/iReport/Java reporting tool Interface with key stakeholders and apply your technical proficiency across different stages of the Software Development Life Cycle including Requirements Elicitation and translating to functional and/or design documentation for LabVantage LIMS solution, Application Architecture definition and Design, Development, Validation and release. Technical and Professional Requirements: Primary skills:Technology->Life Sciences->LIMS Experience in developing instrument drivers using SDMS/Talend/Java is to have. At least 5 years of experience in software development life cycle. At least 5 years of experience in Project life cycle activities on development and maintenance projects. At least 5 years of experience in Design and architecture review. Good understanding of sample management domain and exposure to life sciences projects Ability to work in team in diverse/ multiple stakeholder environment Analytical skills Very Good Communication skills Preferred Skills: Technology->Life Sciences->LIMS Additional Responsibilities: Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability Good knowledge on software configuration management systems Awareness of latest technologies and Industry trends Logical thinking and problem solving skills along with an ability to collaborate Understanding of the financial processes for various types of projects and the various pricing models available Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Client Interfacing skills Project and Team management Educational Requirements Master Of Engineering,Master of Pharmacy,MCA,MTech,Bachelor of Pharmacy,Bachelor of Engineering,BSc,BTech Service Line Engineering Services * Location of posting is subject to business requirements

Should have 3-7 years’ experience in Quality control Testing of Raw materials and Finished products Testing of stability samples Handling of HPLC & GC instruments Handling of Chromeleon software Handling of UV, TOC, FTIR & Auto titrator instruments Instrument calibrations & trouble shooting Handling of LIMS Should have knowledge on GMP/GLP Should have knowledge on OOS/OOT/Deviations/Laboratory incidents

Responsibilities: Manage preparation, review, and timely revision of SOPs, GTPs, and guidelines. Oversee DMS applications and ELN systems. Review and approve analytical protocols, reports (e.g., Method Validation, Verification, Regulatory Queries, Equivalency, PDR, MFC, AMT), and instrument qualifications. Conduct internal audits, lab monitoring, and ensure compliance with GDP and GLP standards. Provide training, review QMS documents (Incidents, Deviations, Change Control), verify electronic data, perform audit trail reviews, and assess Computer System Validation reports

Project Role : Program/Project Management Lead Project Role Description : Manage overall delivery of a program or project to achieve business outcomes. Define project scope and monitor execution of deliverables. Communicate across multiple stakeholders to manage expectations, issues and outcomes. Must have skills : Laboratory Information and Execution Systems Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an LabVantage application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for ensuring the smooth functioning of applications and addressing any issues that arise. Your typical day will involve collaborating with the team to understand requirements, designing and developing applications, and testing and debugging code to ensure optimal performance and functionality. Roles & Responsibilities: Expected to know LabVANTAGE Development independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work-related problems. Collaborate with the team to understand application requirements. Design and develop applications based on business process needs. Test and debug code to ensure optimal performance and functionality. Address any issues or bugs that arise in the applications. Provide technical support and guidance to end-users. Stay updated with the latest industry trends and technologies. Assist in the deployment and maintenance of applications. Professional & Technical Skills: Must To Have Skills:Proficiency in LabVantage Application Development. Strong understanding of software development principles and methodologies. Experience in designing and building applications using Laboratory Information Management System (LIMS) You must have advanced proficiency in Laboratory Information Management System (LIMS) Good To Have Skills:Experience with java, Life Science and, LabVantage dev Recommendation:Knowledge of Java programming language. Additional Information: The candidate should have a minimum of 3 years of experience in LabVantage Application Development. This position is based at Bangalore office. A 15 years full-time education is required. Qualifications 15 years full time education

Project Role : Program/Project Management Lead Project Role Description : Manage overall delivery of a program or project to achieve business outcomes. Define project scope and monitor execution of deliverables. Communicate across multiple stakeholders to manage expectations, issues and outcomes. Must have skills : Laboratory Information and Execution Systems Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Senior LabVantage Tester, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for ensuring the smooth functioning of applications and addressing any issues that arise. Your typical day will involve collaborating with the team to understand requirements, designing and developing applications, and testing and debugging code to ensure optimal performance and functionality. Roles & Responsibilities: Expected to know LabVANTAGE Testing independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work-related problems. Collaborate with the team to understand application requirements. Design and develop applications based on business process needs. Test and debug code to ensure optimal performance and functionality. Address any issues or bugs that arise in the applications. Provide technical support and guidance to end-users. Stay updated with the latest industry trends and technologies. Assist in the deployment and maintenance of applications. Professional & Technical Skills: Must To Have Skills:Proficiency in LabVantage Testing. Strong understanding of Testing methodologies. Experience in designing and building applications using Laboratory Information Management System (LIMS) You must have advanced proficiency in Laboratory Information Management System (LIMS) Good To Have Skills:Experience with java, Life Science and, LabVantage dev Recommendation:Knowledge of Java programming language. Additional Information: The candidate should have a minimum of 3 years of experience in LabVantage Application Testing. This position is based at Bangalore office. A 15 years full-time education is required. Qualifications 15 years full time education

Required Skills: • Resource with 2 -8 years of Relevant experience in Computerized System Validations of Enterprise applications (SAP/LIMS/TrackWise etc.), Equipment and Instrument validations (Manufacturing, Packaging, QC equipment/instruments and Serialization etc.). • Experience in Preparation and Execution of CSV deliverables (IQ, OQ and PQ). • Exposure in Assessment, Review and Preparation of 21 CFR part 11, EU annex 11 Compliance Assessment/Report. • Review of User, Error, Audit Trail records. • Skilled in Risk Assessment for Equipment/Instrument Operations. • Experience in Handling of QMS events (Change control, Deviation, RCI and CAPA). • Experience in Handling of end to end project CSV activities (is an added advantage). Technical Skills required: • Knowledge on handling of ValGenesis Application. • Hands on instrumentation, semi automation or automation • Worked on different layers of automation systems • Knowledge of IT- Operations, data and security management, backup & restore activities, • Exposure to maintenance, troubleshooting of GxP systems, • Understanding of technical & procedural risk assessment and actions. Soft skills (behavioral) required: Self-learner, Team player, Good Communication and Coordination with CFT etc. Any other specification / Requirement: • B. Tech, B.E. B.Sc. – Instrumentation /Electronics/ IT /B. Sc. (Computer Science) having knowledge of SAP, TrackWise, MES, BMS, EMS etc. • B. Pharmacy with exposure in regulation, analytical instrumentation, exposure to production activities along with exposure to latest software LIMS, HPLC etc. Experience Range: 2 to 8 years in Engineering, Consultancy, IT, CSV in Pharma domain

Job Summary: We are seeking an experienced Labware LIMS Developer with 3 to 7 years of hands-on experience to join our team. The ideal candidate will possess a deep understanding of Labware LIMS software and its integration into laboratory processes. The candidate will be responsible for the design, development, customization, and support of the LIMS system. Key Responsibilities: Labware LIMS System Development and Customization: Design, develop, and implement Labware LIMS configurations, enhancements, and customizations. Develop and maintain Labware LIMS workflows, interfaces, and modules. Create custom reports, dashboards, and data visualizations within the Labware LIMS platform. Integrate Labware LIMS with other laboratory systems and enterprise systems (e.g., ERP, CDS and Empower). System Support and Maintenance: Provide ongoing support for Labware LIMS by troubleshooting issues, identifying bugs, and implementing solutions. Perform system upgrades and patch management for Labware LIMS. Monitor system performance, address issues, and ensure data integrity and reliability. Collaboration and Requirement Gathering: Work closely with laboratory and business teams to understand system requirements and ensure LIMS meets operational needs. Prepare and maintain technical documentation, including requirements, system configurations, and testing procedures. Required Qualifications: Experience: 3 to 7 years of hands-on experience in Labware LIMS development, customization, and support. Technical Skills: Strong experience with Labware LIMS software, including configuration, customization, and implementation. Proficiency in programming languages such as JavaScript, C#, or Java, and experience with Labware LIMS scripting. Experience with SQL and database management (e.g., MS SQL Server, Oracle). Familiarity with Labware LIMS integration technologies (e.g., web services, APIs, XML). Experience with LIMS testing, validation, and documentation for regulatory compliance. Education: Bachelor’s degree in Computer Science, Information Technology, or related field (or equivalent experience). Knowledge of Regulatory Standards: Understanding of regulatory guidelines such as 21 CFR Part 11, GxP, and other industry-specific standards. Problem-Solving Skills: Strong analytical skills with the ability to troubleshoot and resolve technical issues effectively. Communication Skills: Excellent verbal and written communication skills, with the ability to collaborate effectively with both technical and non-technical teams. Team Player: Ability to work effectively within a team and independently in a fast-paced environment.

Company: Strides Pharma Department: Quality Control Position: Executive Job Location: KRSG Plant, Alathur Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability

Roles and Responsibilities Material testing of different types of organic and inorganic chemicals Wet Analysis Instrumental Analysis GC, HPLC, pH meter, Spectrophotometer, KF titrator etc Keep records of analysis done and report to QC Manager Desired Candidate Profile : Chemistry Graduate / PG with minimum 8-10 years experience of Working in QC FDA Certified Good Command over English and Excel We prefer if you have worked in Chemical company and worked on SAP Knowledge of ISO 9001, 140001, 22000 and 17025

Project Role : Software Configuration Engineer Project Role Description : Implement the configuration management plan as directed by the Configuration Lead. Assist in the design of software configuration and customization to meet the business process design and application requirements. Must have skills : Laboratory Information and Execution Systems Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Software Configuration Engineer, you will be responsible for implementing the configuration management plan as directed by the Configuration Lead. You will also assist in the design of software configuration and customization to meet the business process design and application requirements. Your typical day will involve collaborating with the Configuration Lead and other team members to ensure smooth implementation of the configuration management plan. You will also contribute to the design and customization of software configurations to align with the business process design and application requirements. Responsibilities:1.As an Application Developer, your day-to-day activities will revolve around leveraging your advanced proficiency in Laboratory Information Management System (LIMS) to develop and maintain software applications. In this role, you'll be responsible for designing, coding, testing, and debugging software applications. Additionally, you'll be entrusted with the task of ensuring seamless integration with other IT components, thus playing a significant role in contributing to the organization's overall success. You must have advanced proficiency in Laboratory Information Management System (LIMS). Having intermediate proficiency in Configuration & Release Management and advanced proficiency in Design & Build Enablement will be advantageous.2.Design, develop, and maintain software applications using Laboratory Information Management System (LIMS)3.Collaborate with cross-functional teams to ensure seamless integration with other IT components4.Conduct rigorous system testing and troubleshooting to optimize the performance of software applications5.Provide expert technical guidance and support to project teams throughout the implementation lifecycle6.Ensure compliance with software development standards and best practices Professional & Technical Skills:1.Must Have Skills:Proficiency in Laboratory Information Management System (LIMS) 2.Strong understanding of software configuration management principles and best practices.3.Experience in designing and customizing software configurations to meet business process design and application requirements.4.Knowledge of software development lifecycle and change management processes.5.Experience with version control systems and tools.6.Good To Have Skills:Experience with software testing and quality assurance processes. Additional Information:a.The candidate should have a minimum of 3 years of experience in Laboratory Information Management System (LIMS) b.This position is based at our Bengaluru office.c.A 15 years full time education is required. Qualifications 15 years full time education

About Krishagni Founded in 2009, Krishagni is a "software product company" specialising in developing software for medical research. Our flagship product, OpenSpecimen, is trusted by over 100 customers across 20 countries. We are a close-knit team of 15+ professionals, operating with a flat hierarchy and a culture free from office politics. At Krishagni, we value performance and innovation and reward excellence generously. Role & responsibilities * Work closely with customers and internal teams to master the OpenSpecimen product. * Responsible for configuring, customizing, and supporting the product * Should be able to use JSON, JavaScript, SQL, R, Python, and other similar tools. * This position is ideal for someone with a technical mindset, a passion for problem-solving, and an interest in delivering excellent end-user support. Preferred candidate profile B.Sc or M.Sc in any bio science or info stream with a flair for programming in SQL, Java Script, R, etc. Perks and benefits * Salary and performance bonus * Rewarding environment to learn and prosper * Liberal and stressfree work culture * Five days a week

Role: Informatics Account Manager || Location: Bangalore, Hyderabad, Ahmedabad Exp - 6-12 yrs Key skills: Should have relevant experience handling laboratory software sales - Informatics Software - Empower / NuGenesis along with good knowledge of Waters Instruments like LC/MS / LC-MS / HPLC. JD: As Product Specialist Informatics: you are an ambassador of Waters and will bring to the market Waters products and services. You will demonstrate a clear grasp of understanding the customers business and its growth plans, as well as be able to take the knowledge and convert that into a solution and offering from Waters, with a primary aim of bringing customer success. This position brings you a great degree of flexibility working in the field. Your role will be designated to either a territory and/or markets. 1.Addressing new and existing customers in diverse markets (All Market: Informatics solutions) 2. Maintaining and developing existing customer and identifying and developing new accounts; 3. Regularly visiting customers within the assigned territory; 4. Organizing, delivering and following up seminars and workshops at customer sites; 5. Providing customers with high quality technical advice whilst maintaining a focus on maximizing the sales potential; 6. Collaborating, liaising and providing guidance and support across departments to ensure customer success. You will be working closely with all other groups at Waters (e.g. Instrument Sales, Chemistry Operation and Service dept etc.); 7. Formulating and successfully implementing business plans; 8. Planning and prioritizing personal time and sales activities; 9. Adhering to Waters and customers relevant Health, Safety and Environment requirements when on site and as an individual employee; 10. Using related systems, e.g., Sales Force, Quotation system, with a keen mind on improvements and upgrades. Education: University Degree in Chemistry or Engineering or equivalent Experience: 6-10 years of experience in IT solution or similar sales or service. Knowledge of Chromatography, Pharmaceutical Lab Compliance and its application Nice to have technical and practical solution Selling Experience, particularly in selling High end Technology products will be an added advantage Competencies: Highly passionate individual with charisma, perseverance and determination, plus the ability to work effectively in competitive sales situations. Customer focused with good level of listening skills. Ability to understand and communicate technical & commercial values. Good interpersonal skills with a positive sense of humors and is able to contributing as part of an integrated sales/service organization; Good priority setting and organizational skills. Proficient English and regional Language Skills. Travel: A clean driving license and a valid passport will be required. This is a territory-based position with travelling within your designated territory, and occasional travels to other countries for activities such as governance of department, local business support, meetings and training. A disclosure of any criminal convictions may be required as some of our customers work in sensitive and confidential government areas.

• Responsible for analytical documents review, filing after approval for: • Batch Analysis • Method Validation and Method Transfers • OOS / OOT Investigations • Stability Protocols, Reports, Data • Certification of standards • Review of Specifications and Test Methods • Review of Calibration and Qualifications of Analytical Instruments • Audit trail review • Should understand all analytical instruments like HPLC, GC, Spectrophotometers, Other analytical instruments • Understanding of good laboratory practices in Quality control and Analytical Development and Validation • Understand 21CFR Part 11 requirements, Audit trail reviews, GMP requirements, ICH guidelines on Specifications, Method validations.

Company: Strides Pharma Department: Quality Control Position: Executive Job Location: KRSG Plant, Bangalore Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability

LIMS Labware application Admin support/Master data experience/ Development and configuration experience. : Job Description 1. Thorough understanding of the QC Lab processes 2. Knowledge of GxP process 3. Proficient in Labware LIMS & ELN template designing and enhance process 4. Collaborate with business units and IT stakeholders to ensure system reliability, security and continuous improvement. 5. Experience in instrument integration with LIMS application and other enterprise applications. 6. Consistent track record of delivering projects with stringent timelines and sprints 7. LIMS application Admin support/Master data experience/ Development and configuration experience. Experience 3-8+ years Role & responsibilities Developer Preferred candidate profile Bangalore

LIMS Labware application Admin support/Master data experience/ Development and configuration experience. : Job Description 1. Thorough understanding of the QC Lab processes 2. Knowledge of GxP process 3. Proficient in Labware LIMS & ELN template designing and enhance process 4. Collaborate with business units and IT stakeholders to ensure system reliability, security and continuous improvement. 5. Experience in instrument integration with LIMS application and other enterprise applications. 6. Consistent track record of delivering projects with stringent timelines and sprints 7. LIMS application Admin support/Master data experience/ Development and configuration experience. Experience 3-8+ years Role & responsibilities Developer Preferred candidate profile Bangalore

Hiring LIMS Developer sought for requirement gathering, configuration, code reviews, support, and collaboration. Oracle/SQL, SAP Crystal reports, GxP, and SDLC knowledge required. Location - JP Nagar, Bangalore Experience - 6+ Years Np - 1 Month

Hiring LIMS Developer sought for requirement gathering, configuration, code reviews, support, and collaboration. Oracle/SQL, SAP Crystal reports, GxP, and SDLC knowledge required. Location - JP Nagar, Bangalore Experience - 6+ Years Np - 1 Month

The Biotech Laboratory Specialist will ensure that all activities within the department align with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). This role is critical for managing and performing a range of laboratory techniques, including PCR, ELISA, Capillary Electrophoresis, Isoelectric Focusing, Western Blotting, and Flow Cytometry. The specialist will also be responsible for preparing and executing method validation protocols and reviewing routine analysis reports. Experience with Quality Management Systems (QMS), particularly LIMS and EQMS, is essential. Key Responsibilities: Laboratory Techniques: Perform Polymerase Chain Reaction (PCR) assays for molecular analysis. Conduct Enzyme-Linked Immunosorbent Assay (ELISA) tests for biochemical assays. Operate and maintain Capillary Electrophoresis and Isoelectric Focusing systems. Execute Western Blotting and Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE) techniques for protein analysis. Perform Flow Cytometry for cell analysis and sorting. Conduct other biochemical and molecular biology tests as required. Method Validation: Develop and prepare method validation protocols to meet regulatory and internal standards. Execute validation procedures in accordance with regulatory guidelines and company practices. Accurately document and report validation results in a timely and comprehensive manner. Report Review: Review routine analysis reports to ensure accuracy, compliance with quality standards, and adherence to regulatory requirements. Identify and investigate any discrepancies or deviations in data, ensuring proper corrective actions are taken. Quality Management Systems: Maintain and manage Laboratory Information Management Systems (LIMS) for effective sample tracking and data management. Support and contribute to the Electronic Quality Management Systems (EQMS) to enhance and maintain laboratory quality processes. Ensure compliance with internal quality standards and regulatory guidelines at all times. Experience & Qualifications: Experience: 4-5 years of hands-on laboratory experience in a biotech or pharmaceutical setting. Education: Masters degree in Biotechnology or a related field. Key Skills: Expertise in PCR, ELISA, Capillary Electrophoresis, Isoelectric Focusing, Western Blotting, SDS-PAGE, and Flow Cytometry. Strong understanding of method validation and documentation. Familiarity with LIMS and EQMS systems. Knowledge of cGMP and cGLP requirements. Excellent attention to detail and strong problem-solving abilities. Work Schedule: Flexibility to work in 1st , 2nd , and General shifts as required. Additional Requirements: A proactive approach to quality and compliance, with a commitment to improving lab efficiency and accuracy. Ability to handle multiple tasks and meet deadlines in a dynamic, fast-paced environment.

Job Description- Labvantage 4-10 years experience in LabVantage LIMS implementation experience of LV8.x projects Must have experience in requirement analysis and system designing. Must have hands on experience in configuration and/or coding in LabVantage. Strong understanding of SDLC & CSV methodologies Must have good communication skills and have experience in customer communication. Strong understanding of Oracle, PL/SQL Workable experience in Jasper reporting will be preferred. Proven team leader – ability to mentor team to deliver results Must be adept in at least: Java (J2EE), JavaScript, JSP, HTML, DHTML/Web Page Development including client-side scripting and SQL for relational databases (either Oracle and/or SQL Server) Other desirable technical skills include Web Service, Ajax, Groovy and J-Query System Analysis, in addition to domain knowledge of laboratory practices. Excellent problem-solving skills Ability to identify ways to continuously improve processes which will help in delivering superior solutions on time and in budget

Good experience in automation like uipath, blue prism and mandatory 4+ of years in MuleSoft RPA. Having the ability to lead the teams.. Good Salesforce/LIMS knowledge and domain knowledge of health care will be a plus.

Role & responsibilities Oversee and manage the Quality Control department to ensure efficient laboratory operations. Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards. Supervise and mentor QC staff, providing training and technical support to maintain high performance. Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products. Ensure timely and accurate analytical testing, stability studies, and method validations. Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA). Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes. Review and approve analytical data, reports, and COAs (Certificates of Analysis). Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment. Manage laboratory documentation, ensuring compliance with data integrity guidelines. Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses. Stay updated on industry trends, regulatory changes, and advancements in analytical techniques. Qualifications & Experience: Bachelor's/Masters degree in Pharmacy, Chemistry, Microbiology, or a related field. Minimum [X] years of experience in Quality Control within the pharmaceutical industry. Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.). Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc. Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation. Strong leadership, problem-solving, and decision-making skills. Excellent communication and interpersonal skills. Proficiency in laboratory data management systems and Microsoft Office tools. Preferred Skills: Knowledge of pharmaceutical microbiology and environmental monitoring. Experience with LIMS (Laboratory Information Management Systems). Certifications in Quality Management Systems (QMS) would be an advantage. Employment Type: Full-time Compensation: Competitive salary based on experience and industry standardOversee and manage the Quality Control department to ensure efficient laboratory operations. Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards. Supervise and mentor QC staff, providing training and technical support to maintain high performance. Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products. Ensure timely and accurate analytical testing, stability studies, and method validations. Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA). Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes. Review and approve analytical data, reports, and COAs (Certificates of Analysis). Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment. Manage laboratory documentation, ensuring compliance with data integrity guidelines. Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses. Stay updated on industry trends, regulatory changes, and advancements in analytical techniques. Qualifications & Experience: Bachelor's/Master’s degree in Pharmacy, Chemistry, Microbiology, or a related field. Minimum [X] years of experience in Quality Control within the pharmaceutical industry. Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.). Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc. Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation. Strong leadership, problem-solving, and decision-making skills. Excellent communication and interpersonal skills. Proficiency in laboratory data management systems and Microsoft Office tools. Preferred Skills: Knowledge of pharmaceutical microbiology and environmental monitoring. Experience with LIMS (Laboratory Information Management Systems). Certifications in Quality Management Systems (QMS) would be an advantag

Project Role :Application Lead Project Role Description :Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills :Rockwell Good to have skills :NA Minimum 7.5 year(s) of experience is required Educational Qualification :1 Minimum 15 years of full time education Key Reponsibilities :1 Must have skill SAP DMC Technical Functional consultant 2 Must have experience in the MII core areas of building Queries, Business Logic Transactions, Plant Information Catalog, SSCE, SAP OEE module, and Interface to SAP ECC S4HANA 3 Must have experience in DMC core areas of application configuration, BOM, Routing, Data Collection, Resource Orchestration, Shopfloor Designer, Insights and Interface to SAP SCC S4HANA Technical Experience : 1 3 to 6 years of experience in SAP MII, SAP ME and SAP DMC 2 Must have participated in at least 2 end to end implementations. 3 Must have experience in conducting explore workshops, writing scope document and technical design document. 4 Must have process knowledge from the Discreet Manufacturing and or Process Industry 5 Must have experience in the PCo setup for integration to shopfloor systems like SCADA, DCS, Historian, LIMS etc. Professional Attributes :1 Good Communication skill 2 Good analytical skill