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3.0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
About Us Serving more than 350 customers in 35+ countries, Xybion has the global scale and expertise to bring employees around the world together to drive the digital transformation of laboratories. Xybion is a leading ai enabled software as a service company dedicated to helping corporations solve business problems through intelligently designed software products and business processes. We help companies become more efficient, reduce costs and manage compliance, regulatory adherence, and risk. Our unique solutions focus on integrated preclinical lab management LIMS, all lab LIMS, ELN, QMS, and Risk Prediction software’s. Xybion Consulting offers Design Thinking, Business Analysis, PMO, Risk & Compliance services and computer systems validation. Since its founding in 1977, Xybion Corporation has supported, through software, services and consulting, 100% of the top 20 global life sciences companies. You can learn more about our solutions here: https://www.xybion.com Role: Senior Test Engineer Location: Chennai & Pune, India The Senior test Engineer participates in Quality Control stage testing and evaluation of Xybion or third-party software products either independently or as a team member or leader. They may also create test scripts or test cases to be traceable to defined functional requirements of each applicable product and may also be responsible for review and approval of test cases created and/or executed by other Testers. The Senior Tester must be able to work independently and must be able to supervise the work of other Testers as part of a team working either internally or externally on behalf of a Xybion client. Key Responsibilities: Write and review quality test cases based on product functional requirements and in accordance with applicable standard operating procedures Ensure validation documentation (OQ/IQ/PQ) meets industry standards (21 CFR Part 11, GxP, FDA guidelines). Execute test cases according to instructions and in compliance to Good Documentation Practices Report and assist in resolution of issues encountered during testing Analyze/triage issues encountered during testing, both of own testing and others’, and escalate appropriately when required. Supervise work of other testers Testing may include but is not limited to Regression Testing, Adhoc Testing, Smoke Testing, Performance Testing Other duties as assigned Minimum of 4+ yrs experience in software testing under an SDLC designed for pharmaceutical or similar regulatory compliance. Prior experience supervising teams of personnel helpful. Prior work experience in FDA-regulated environment helpful. Proficient working in Microsoft Office applications Knowledge of domain and applications being tested In-depth understanding of FDA GMP/QSR regulations and associated requirements for electronic records and Good Documentation Practices In-depth understanding of validation expectations for FDA regulated companies. Education Requirements: Bachelor’s degree in a scientific, regulatory, or technical discipline, or Associates degree and minimum of 3 years previous work experience in regulated industry. Equivalent prior work experience may substitute for degree requirements at discretion of Manager. Compensation: We offer highly competitive compensation, including base salary, commission/ performance-linked bonus, along with a comprehensive benefits package. We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/. Xybion is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by fede
Posted 1 month ago
3.0 - 8.0 years
8 - 12 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : LIMS, GMP, cGMP, Starlims, Labware Lims, Labvantage. The opportunity Were looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our 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 Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. 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, 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 Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills. Interested Candidates can send their Cv's to frichardson@allegisglobalsolutions.com. Regards, Franklin.A
Posted 1 month ago
3.0 - 8.0 years
8 - 14 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, 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 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 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 and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A
Posted 1 month ago
5.0 - 9.0 years
12 - 24 Lacs
Bengaluru
Work from Office
Collaborate with cross-functional teams on project delivery. Design, develop, test & maintain starlims solutions using .NET, MS SQL & PostgreSQL. Configure historians, SAP, Oracle systems integration. StarLIMS + Dot Net, C# knowledge is mandatory
Posted 1 month ago
5.0 years
0 Lacs
Etawah, Uttar Pradesh, India
On-site
Job Title: QC Executive – (RM / FG / Stability / AMV & PV / Microbiology) Location: Indore – Regulated Pharma Manufacturing Plant Department: Quality Control Reporting To: QC Manager / Head – Quality Control Job Type: Full-Time | Executive Level Job Purpose To perform quality control testing and analysis of raw materials, finished products, stability samples, and microbiological parameters as per current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), pharmacopeial standards, and regulatory requirements to ensure product quality and compliance. Key Responsibilities Testing and Analysis Perform chemical and instrumental testing of Raw Materials (RM) and Finished Goods (FG) as per pharmacopeial and in-house specifications. Conduct Stability Studies in line with ICH guidelines and maintain records of stability trends. Execute Analytical Method Validations (AMV) and support Process Validation (PV) testing. Carry out Microbiological analysis of samples, including environmental monitoring, water testing, and microbial limit tests. Documentation and Compliance Maintain accurate, complete, and timely documentation (analytical reports, logbooks, LIMS/ERP entries). Ensure compliance with cGMP, GLP, and regulatory standards (USFDA, EU-GMP, WHO, etc.) . Participate in internal audits, external regulatory inspections , and implement CAPAs. Prepare and review standard operating procedures (SOPs), specifications, and testing protocols. Equipment Operation & Calibration Operate and calibrate instruments like HPLC, GC, UV, IR, Dissolution Apparatus, FTIR, etc. Ensure timely preventive maintenance and validation of QC instruments. Cross-functional Coordination Coordinate with Production, QA, Regulatory Affairs, and other relevant departments to resolve testing issues and support product release timelines. Participate in investigations of OOS/OOT results, deviations, and change controls. Key Skills & Competencies Sound knowledge of cGMP/GLP and ICH guidelines. Hands-on experience with analytical instruments and microbiology techniques. Strong documentation and data integrity practices. Good communication and team collaboration skills. Eye for detail and high level of integrity. Educational Qualifications B.Pharm / M.Pharm / M.Sc. (Chemistry / Microbiology / Pharmaceutical Sciences) Experience 2–5 years of relevant experience in a regulated pharmaceutical manufacturing environment. Preferred Certifications Training in Data Integrity, cGMP, QMS, or Instrument Handling is an advantage.
Posted 1 month ago
2.0 - 6.0 years
5 - 9 Lacs
Vadodara
Work from Office
About Sun Pharma: Sun Pharmaceutical Industries Ltd (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5 4 billion Supported by 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe, Job Summary Integration Specialist LIMS, will be responsible for the integrating various lab instruments/software with LIMS application for successfully establishing paperless environment in QC/R&D Labs This role requires a deep understanding of laboratory workflows, Instrument connectivity techniques, strong technical skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Roles and Responsibilities Support in QC/R&D lab instrument integration with LIMS application, at the time of LIMS implementation at various locations of SUN Pharma, Develop and execute test scripts, and relevant documentations required as part of validation activity, Configure LIMS software to meet the specific needs during Instrument integration activity, Provide training and support to end-users, ensuring they are proficient in using the LIMS, Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments, Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals, Shall be aware about documentation of LIMS application as per GMP Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state, Qualifications and Preferences Qualifications: Bachelor's degree in Information Technology, or Computer Science or related field, Minimum of 4-5 years of experience in LIMS implementation & Instrument Integration activity, preferably in a pharmaceutical or biotech environment, Strong understanding of laboratory processes and workflows, Deep understanding of Lab Software functionality such as Empower, LabSolutions, Chromeleon, Strong command on Data extraction / connectivity methodologies techniques for port based instruments such as balances, pH etc Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) Strong analytical and problem-solving skills, Excellent communication and interpersonal skills, Experience with regulatory compliance requirements (e-g , FDA, GMP, GLP), Preferred Qualifications: Advanced degree in Life Sciences, Information Technology, or a related field, Familiarity with laboratory instruments and their integration with LIMS Experience with Caliber LIMS is preferred, Good documentation skills to create and manage GxP documents, Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya Only applications received through Jigya will be evaluated further, Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma
Posted 1 month ago
1.0 - 5.0 years
2 - 5 Lacs
Vadodara
Work from Office
About Sun Pharma: Sun Pharmaceutical Industries Ltd (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5 4 billion Supported by 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe, Job Summary LIMS Testing & Documentation Specialist will be responsible for the thorough testing of LIMS application before deployment or patch deployment This role requires a deep understanding of laboratory workflows, strong technical & testing skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Roles and Responsibilities Support testing of LIMS functionalities to ensure the functionality available, is working as per usersexpectation as well as it meets the approved user requirement specification, Develop testing strategy and execute it to meet the implementation timelines, Perform the impact assessment of newly added functions on the existing functionalities, Rigorously test the newly introduced functionalities based on its impact on the existing functionalities, Provide training and support to end-users, ensuring they are proficient in using the LIMS, Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments, Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals, Shall be aware about documentation of LIMS application as per GMP Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state, Qualifications and Preferences Qualifications: Bachelor's degree in Information Technology, or Computer Science or related field, Minimum of 4-5 years of experience in LIMS implementation & Instrument Integration activity, preferably in a pharmaceutical or biotech environment, Strong understanding of laboratory processes and workflows, Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) Excellent testing skills, with the ability to manage multiple tasks and projects simultaneously, Strong analytical and problem-solving skills, Excellent communication and interpersonal skills, Experience with regulatory compliance requirements (e-g , FDA, GMP, GLP), Preferred Qualifications: Advanced degree in Life Sciences, Information Technology, or a related field, Familiarity with laboratory instruments and their integration with LIMS Experience with Caliber LIMS is preferred, Good documentation skills to create and manage GxP documents, Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya Only applications received through Jigya will be evaluated further, Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma
Posted 1 month ago
10.0 years
4 - 7 Lacs
Hyderābād
On-site
Date: May 27, 2025 Job Requisition Id: 59868 Location: Hyderabad, IN Pune, IN YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we’re a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth – bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hire SAP PP/QM Professionals in the following areas : As a SAP PPQM Solution Architect, you will be responsible for leading the design and implementation of SAP PPQM solutions tailored to meet the organization’s needs. You will collaborate closely with business stakeholders, SAP functional teams, and technical experts to develop innovative solutions that optimize processes, enhance efficiency, and drive business value. This role requires a deep understanding of SAP PPQM functionalities, industry best practices, and a strategic mindset to architect scalable and sustainable solutions. Key Responsibilities: Provide consulting services and guidance to clients, recommending best practices and optimal solutions.Support pre-sales activities by participating in RFPs, preparing proposals, and providing technical expertise to clients. Demonstrate strong communication skills by effectively communicating technical concepts to both technical and non-technical stakeholders. Provides technical and consultative leadership for solution opportunities on a range of complex engagements. Collaborate with functional consultants and other technical experts to deliver integrated solutions. Expert in leading pre-sales meeting or presentation and customer demos in sap. Interact directly with customers to translate business requirements into solutions. Lead with estimates, review RFI. RFP response and SOW documentation. Able to assist in creating winning proposals that address current and evolving client requirements. Defines and authors deliverables. Ability to validate requirements, functionality /solution design and architect the solution and articulate value proposition. Understands customer business challenges and provides strategy that addresses long term goals. Ability to work against defined schedules and deliver to expectation. Perform system performance optimization and troubleshooting as needed. What you bring to be Successful: Proven experience in sap manufacturing (PP/QM) and industry experience. 10+ years of strong sap manufacturing expertise wherein worked as analyst, configurator and lead in PP and QM areas. Worked as onsite delivery lead for at least 3 full life-cycle e2e implementation projects and at least one on S4HANA (greenfield or brownfield). Proven and strong experience in PP/QM with good knowledge on cross module integrations. Experience of working on plant maintenance/EAM solutions is desirable. Hands-on experience in implementing PP/QM in a discrete and process industry. Experience of working in a validated environment is desirable. Knowledge of advanced planning solutions is a plus. Good knowledge third-party tools in the manufacturing space (LIMS, MES, Track-wise). Excellent knowledge of project implementation methodologies w.r.t sap products. Excellent written and verbal communication skills, Strong presentation skills and people management skills. At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture
Posted 1 month ago
0 years
0 - 0 Lacs
India
On-site
1. Ability to independently review Machine Results and approve Reports 2. Knowledge of NABL Compliances 3. Knowledge of LIMS with inventory module and Quality Control 4. Preference for candidates willing to stay nearby 5. Min 10 Yrs Job knowledge is essential 6. Proficiency in Computer ( Essential) Job Types: Full-time, Permanent Pay: ₹11,000.00 - ₹12,000.00 per month Benefits: Commuter assistance Schedule: Day shift Evening shift Work Location: In person Expected Start Date: 25/06/2025
Posted 1 month ago
5.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About The Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e.g., LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth). Minimum Requirements Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc. Fluent in English (oral and written).Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less
Posted 1 month ago
6.0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
What's The Role The FPP Scheduling Advisor aids sites to deliver maximum value from margin optimization activities implementing planning and scheduling work processes, increasing staff competencies, assuring accurate representations in optimization and scheduling models (including gasoline blending). They provide deep expertise in the understanding and use of the site Scheduling Models for Refinery and Chemical site planning through the deployment of cutting-edge technology. The Advisor works in close collaboration with site E&S teams, TAS E&S team, P&T Basic Data, Scheduling, Crude and FPP Excellence Advisors. The FPP Scheduling Advisor Role is seen as critical to ensuring that the E&S community is well supported and to help maximize value generation from our sites. This role is expected to be fully accountable for the activities below. What You'll Be Doing MODELING Acts as primary technical expert for E&S Scheduling tool (currently Aspen’s APS/Orion), supporting site Scheduling teams. (Scheduling and Blending) Supports practitioners with urgent problem solving to ensure business continuity and escalates to central TBI Optimization Advisors or 3rd Party vendor as appropriate. Implements new advanced simulation and optimization capabilities and better representation (including visualization) of process plants in Scheduling tools. Supports in the assurance that scheduling models are lean, up to date and changes are communicated amongst Scheduling and Planning Advisors and EMC’s to ensure alignment between PIMS, Orion and MBO models. Provides support to configure all existing and new reports from the tools. Supports programming, testing, enhancements, configuration, maintenance of non-IT supported data input and Solution reports. Maintain best practice recommendations in a structured fashion and help propagate these within the E&S practitioner community for Scheduling and Blending. Support in effective backcasting activity and practices that ensures the health and fidelity of the relevant submodels, databases, data tables, model logic, stream routings, blend rules and properties, with the intent of constantly driving optimal solutions and decision making by the practitioners. TRAINING / DEVELOPMENT Supports with the onboarding of new employees with scheduling tools and all relevant FPP work processes. MARGIN OPTIMIZATION STUDIES Support with structured margin improvement interventions and ensures / assists with implementation of recommendations as relevant with Scheduling and Blending capability of sites. DATA INTERFACES Ensures validation of data flows of daily baseline data interface configurations (PI and LIMS), all movement interface configurations and all hourly plant data (PI and LIMS) into the ‘model accuracy’ graphs (configuration, troubleshooting, and display) Coordinate data interface bug fixes or enhancements with IT. INSTALLATIONS AND TROUBLESHOOTING Provides business advice to DS IT regarding Scheduling/Blending PC software installations and helps troubleshooting where needed Configure and support maintenance of Add-ons (with data tables/files) for standard and site relevant work-processes. Coordinate Add-on bug fixes or enhancements, Beta Testing and User Acceptance testing with IT. DATABASE MANAGEMENT Coordinates database table purge requirements (retention days/dates) to stay consistent with site work processes and to prevent the database size from causing failures in MDB backup creation. Corroborates with IT to ensure all SQL and MDB backup creations are complete and routine (which involves oversite/monitoring). Provides site database user account management, including user group model/event permissions configuration setup and changes. Provides maintenance, programming, and updating of the site MDB Pass-through database (including up-to-date AspenTech data queries). GENERAL E&S SUPPORT Ensures compliance with the requirements and consistent application of the FPP planning work processes in AMS and assists with the closure of recommendations. Scheduling Advisor will lead regional Scheduling networks with support from a sponsoring E&S Manager. CHALLENGES Networks will play a key role in the new organizational setup to ensure peer-to-peer collaboration and support between the various sites, as well help in ensuring best practices in the relevant areas are being pursued at all sites. The Advisor will network with their colleagues in the Europe and Americas regions to ensure inter-regional connectivity. What You Bring Preferably with a University Degree in Chemical Engineering or Petroleum Engineering, with relevant refinery oil and gas experience. Preferably with at least 6 years of experience in refinery planning and scheduling space working with planning tools or Software Industry associated with developing product and tools for Refinery Planning and Scheduling space Preferably with mastery level experience in Aspen Petroleum Scheduler (APS) / Aspen Unified Scheduling (AUS) Has deep knowledge around the utilization of hydrocarbon and refinery economic value drivers Able to demonstrate commercial mindset to identify and drive margin opportunities to delivery Excellent analytical, oral and written communication skills Team player and self-motivated. What We Offer You bring your skills and experience to Shell and in return you work with talented, committed people on one of the most important challenges facing our planet. You’ll have the opportunity to develop the skills you need to grow in an environment where we value honesty, integrity and respect for one another. You’ll be able to balance your priorities as you become the best version of yourself. Progress as a person as we work on the energy transition together. Continuously grow the transferable skills you need to get ahead. Work at the forefront of technology, trends and practices. Collaborate with experienced colleagues with unique expertise. Achieve your balance in a values-led culture that encourages you to be the best version of yourself. Join an organization working to become one of the most diverse and inclusive in the world. We strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation and life experiences to apply. Grow as you progress through diverse career opportunities in national and international teams. Gain access to a wide range of training and development programs. Shell in India Shell is a diversified energy company in India with 13,000 employees, and presence in Integrated Gas, Downstream, Power, Renewable and Upstream. Additionally, we have deep capabilities in R&D, digitalisation, and business operations. Our global strategy, Powering Progress, is designed to generate value for our shareholders, customers, and the wider society, and focuses on creating more value with less emissions. The strategy supports our purpose of providing more and cleaner energy solutions, with the aim of profitably transforming Shell into a net-zero emissions energy business by 2050. As India moves towards its target of net-zero emissions by 2070, Shell India aims to play a leading role in securing vital energy for today, while investing in, and helping to build, the energy system of the future through strategic investments in the country. Our Lubricants business serves over 50,000 consumers through a strong network of over 200 distributors, and operates an end-to-end value chain that spans conceptualization, development, and production at a world-class blending plant at Taloja. Through our 350-plus retail stations, we offer an integrated mobility experience including fuels, cafes, and convenience stores, with a prominent network of EV recharging facilities. Shell owns and operates a LNG re-gasification terminal at Hazira, Surat, with a capacity of 5 MTPA and a LNG truck-loading unit that plays a crucial role in helping meet India’s growing demand for gas across sectors. In 2022, Shell acquired Sprng Energy in a $1.55 billion deal to build an integrated energy transition business in the country. Sprng is a leading renewable energy company in India which develops and manages solar, wind, and hybrid power generation facilities and infrastructure. Our three capability centres across Bangalore and Chennai serve as a technology and innovation powerhouse for Shell globally, working as a delivery engine for core technical, digital, and finance processes: pioneering digital innovation and cutting-edge technologies across the energy sector. We also have strong academic partnerships and collaborations with leading universities and technology institutes to accelerate decarbonization efforts within the energy sector. We are committed to positively contributing to the communities in which we operate through programmes on STEM Education, Skilling, and Livelihood across India. We nurture and invest in startups developing initiatives focused on accelerating energy innovation through programs such as Shell E4 and Shell Eco-marathon. We also have strategic investments in new energy companies such as Husk Power, d.light, Orb Energy, and Cleantech Solar. Show more Show less
Posted 1 month ago
3.0 - 4.0 years
2 - 3 Lacs
Mumbai
Work from Office
Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills
Posted 1 month ago
0 years
0 Lacs
Daund, Maharashtra, India
On-site
1. User Support & Troubleshooting Provide technical support to plant personnel for issues related to desktop systems, laptops, printers, HMIs, label printers, and mobile devices. Troubleshoot application errors (e.g., LIMS, SAP, MES, SCADA) and escalate where required. Support users working in cleanroom and GxP-compliant areas with proper adherence to gowning and hygiene protocols. 2. Ticketing & Documentation Record all incidents, service requests, and changes in the ITSM/ticketing system (e.g., ServiceNow, Remedy). Ensure tickets are logged with complete details, categorization, and impact level. Close calls with proper resolution notes and user confirmation. 3. Compliance Support (GxP/CSV) Ensure IT procedures in plant areas comply with data integrity, audit trail, and change management standards. Follow Good Documentation Practices (GDP) while recording actions and resolutions. Support execution of IT tasks during validation, calibration, or equipment qualification activities. 4. Asset & Access Management Assist in managing IT assets within the plant (PCs, scanners, handhelds, industrial PCs). Perform user provisioning and de-provisioning in line with pharma plant policies and audit trails. Track movement and assignment of IT equipment and maintain audit-ready records. 5. System Monitoring Monitor critical manufacturing systems and interfaces (e.g., PLCs, MES terminals). Escalate alarms or downtimes impacting production immediately to relevant IT/OT teams. 6. Coordination with IT/OT/QA Teams Work closely with OT engineers and QA teams during equipment/software incidents. Coordinate with central IT or external vendors for issues beyond local resolution. Support during audits and inspections by providing IT records or logs when required. 7. Preventive Maintenance & Housekeeping Participate in scheduled IT system health checks and backups. Ensure IT systems and cables in cleanroom areas are well-maintained and do not violate GMP conditions. 8. Reporting & Communication Share daily/weekly status reports on tickets, system issues, and user feedback. Proactively communicate planned maintenance, outages, or updates to relevant plant departments. Show more Show less
Posted 1 month ago
0 years
0 Lacs
India
Remote
Company Description SMART IT PROS INC is an IT and Business Services organization that provides comprehensive solutions to enhance client performance, flexibility, and cost efficiency. As a certified women-owned and minority-owned business, the company offers a wide range of IT hardware, software, and networking products and services. Key offerings include cyber security monitoring, cloud-hosted solutions, enterprise content management, and IT staffing, among others. With a commitment to meeting organizational needs, SMART IT PROS INC delivers high-quality application and business process services. Role Description This is a contract, remote role for a LIMS Sample Manager. The LIMS Sample Manager will be responsible for managing and tracking laboratory information management system (LIMS) samples, ensuring accurate sample entry, updating and maintenance. Tasks will include working closely with laboratory staff to ensure timely and accurate data entry, managing sample inventory, coordinating with various teams for sample analysis, and generating reports. The role will require adherence to regulatory standards and ensuring data integrity throughout all processes. Qualifications Experience with LIMS, sample management, and laboratory operations Proficiency in data entry, data management, and generating reports Strong organizational and time management skills Excellent communication and teamwork abilities Attention to detail and commitment to data integrity Ability to work independently and remotely Experience in a regulated laboratory environment is a plus Bachelor's degree in Life Sciences, Chemistry, Data Management, or related field Show more Show less
Posted 1 month ago
10.0 - 12.0 years
0 Lacs
Hyderabad / Secunderabad, Telangana, Telangana, India
On-site
Job Description : YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we're a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth - bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hireSAP PP/QM Professionals in the following areas : As a SAP PPQM Solution Architect, you will be responsible for leading the design and implementation of SAP PPQM solutions tailored to meet the organization's needs. You will collaborate closely with business stakeholders, SAP functional teams, and technical experts to develop innovative solutions that optimize processes, enhance efficiency, and drive business value. This role requires a deep understanding of SAP PPQM functionalities, industry best practices, and a strategic mindset to architect scalable and sustainable solutions. Key Responsibilities: Provide consulting services and guidance to clients, recommending best practices and optimal solutions.Support pre-sales activities by participating in RFPs, preparing proposals, and providing technical expertise to clients. Demonstrate strong communication skills by effectively communicating technical concepts to both technical and non-technical stakeholders. Provides technical and consultative leadership for solution opportunities on a range of complex engagements. Collaborate with functional consultants and other technical experts to deliver integrated solutions. Expert in leading pre-sales meeting or presentation and customer demos in sap. Interact directly with customers to translate business requirements into solutions. Lead with estimates, review RFI. RFP response and SOW documentation. Able to assist in creating winning proposals that address current and evolving client requirements. Defines and authors deliverables. Ability to validate requirements, functionality /solution design and architect the solution and articulate value proposition. Understands customer business challenges and provides strategy that addresses long term goals. Ability to work against defined schedules and deliver to expectation. Perform system performance optimization and troubleshooting as needed. What you bring to be Successful: Proven experience in sap manufacturing (PP/QM) and industry experience. 10+ years of strong sap manufacturing expertise wherein worked as analyst, configurator and lead in PP and QM areas. Worked as onsite delivery lead for at least 3 full life-cycle e2e implementation projects and at least one on S4HANA (greenfield or brownfield). Proven and strong experience in PP/QM with good knowledge on cross module integrations. Experience of working on plant maintenance/EAM solutions is desirable. Hands-on experience in implementing PP/QM in a discrete and process industry. Experience of working in a validated environment is desirable. Knowledge of advanced planning solutions is a plus. Good knowledge third-party tools in the manufacturing space (LIMS, MES, Track-wise). Excellent knowledge of project implementation methodologies w.r.t sap products. Excellent written and verbal communication skills, Strong presentation skills and people management skills. At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment.We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture
Posted 1 month ago
3.0 - 5.0 years
0 Lacs
Goa, India
On-site
Key Responsibilities Review and verify accompanying documentation for regulatory samples received from authorities. Coordinate with officials for any clarifications required. Categorize samples upon receipt and assign relevant testing parameters in accordance with FSSR, surveillance plans, or specific instructions from regulatory bodies. Ensure that all testing procedures are performed strictly in accordance with approved protocols and regulatory standards. Conduct verification and authorize final reports as per the requirements of FSSR, clearly indicating compliance or non-compliance with applicable food standards. Oversee proper handling, storage, retention, and timely disposal of regulatory samples in line with SOPs. Ensure turnaround times (TAT) are met as per requirements for import, legal, and surveillance samples. Manage timely uploading of completed reports onto the Infolnet portal following analysis. Collaborate with Microbiology and Instrumentation teams to ensure timely testing and integrated reporting. Participate in the submission of regulatory data, including monthly testing summaries, feasibility responses, and other official communications as required by FSSAI or FDA. Supervise laboratory personnel engaged in food testing activities and ensure adherence to quality protocols. Review test results generated by junior analysts and technicians for completeness and accuracy. Train and mentor team members on regulatory testing methodologies and best practices. Stay updated with changes in FSSAI guidelines, methods, and relevant national/international food laws to ensure continuous compliance. Qualifications Educational Background: Master’s degree in Chemistry (Analytical, Organic, or Inorganic), B.Tech in Food Technology, or any other degree with specialization in Food Technology. Experience: 3-5 years of relevant experience of working as a FSSAI Food Analyst Required Skills Analytical Skills: Proficiency in conducting chemical and microbiological analyses. Time Management: Ability to manage multiple tasks efficiently and meet deadlines. Attention to Detail: Meticulous in documentation and adherence to protocols. Team Collaboration: Effective communication and teamwork abilities Preferred Skills Familiarity with laboratory instruments such as HPLC, GC-MS, and ICP-MS. Knowledge of food safety standards and regulations (e.g., FSSAI guidelines). Experience with Laboratory Information Management Systems (LIMS). Show more Show less
Posted 1 month ago
2.0 - 4.0 years
1 - 4 Lacs
Hyderabad
Work from Office
Handling all SOP based calls and providing the first level resolutions. Provide IT support for plant operations. Perform SOP based activities including App support, User and Access Management, Backup and Restoration, Date and Time Check, Windows Controller Checks, Pre-emptive Maintenance Checks etc. Assist with the setup and maintenance of plant equipment. Respond to and resolve plant-related IT incidents. Maintain inventory of plant IT supplies and equipment. Coordinate plant IT projects and initiatives. Develop and update plant support documentation.
Posted 1 month ago
3.0 years
0 Lacs
New Delhi, Delhi, India
On-site
Job Title : Environmental PCR Laboratory Supervisor 📍 Location : Indira Gandhi International Airport 🌍 Employment Type : Full-time 🧾 Job Description We are hiring a skilled and motivated Laboratory Supervisor to lead operations in an Environmental PCR Laboratory . This leadership role involves overseeing PCR workflows, managing laboratory teams, maintaining compliance, and ensuring high-quality results in a dynamic, regulated setting. 🛠️ Key Responsibilities Supervise daily operations of a PCR laboratory and manage technical staff. Lead, plan, and execute PCR assays, including RNA extraction and optimization. Implement and monitor quality control and biosafety standards. Analyze data and contribute to interpretation and reporting of PCR results. Maintain and calibrate lab instruments such as thermal cyclers and centrifuges. Train and mentor lab personnel, promoting continuous learning and technical growth. Manage inventory of lab supplies and coordinate equipment maintenance. Ensure compliance with international regulatory and safety protocols. 🎓 Qualifications Bachelor’s or Master’s degree in Molecular Biology, Genetics, or a related field. Minimum 3 years of hands-on experience in PCR and laboratory team supervision. Strong understanding of primer design, assay development, and troubleshooting. Proven leadership and communication skills. Proficiency in data analysis tools and laboratory information systems (LIMS). Ability to work under pressure and deliver results in fast-paced environments. Willingness to travel internationally for short-term or mid-term assignments. Show more Show less
Posted 1 month ago
130.0 years
0 Lacs
Hyderābād
On-site
Job Description Senior Manager, Digital Labs - SDLC Coordinator The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role Overview: Join us and be part of our dedicated team that provides support for our Laboratories to improve efficiency, reporting and compliance while improving LIMS Platform stability and useability. This opportunity will also involve working on our Laboratory Transformation program, which is a multi-year, phased approach to streamline and standardize our QC labs to prepare each site to a level playing field of maturity for full digitalization. What will you do in this role: Manage all the System Development Lifecycle (SDLC) activities and records for the Global LIMS Labware platform. Manage multiple validation personnel including internal resources and external contractors. Create validation work estimates for projects. Contribute to improving the validation processes to improve quality and delivery efficiency. Ensure compliance to all procedures, especially quality procedures. Create and/or support the execution of Development Testing (DT) and User Acceptance Testing (UAT) Test Scripts Create Test Summary Documents Identify and Report test/system Defects. Create and Update validation deliverables such as Requirements, Risk Assessments, Trace Matrices and Test Plans. Develop and maintain good Labware Product knowledge Willingness and ability to collaborate/communicate with the Global LIMS Team and Quality Stakeholders. What Should you have: Bachelor's degree in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field. Experience managing a team with ability to motivate. 3+ years of experience in software testing, preferably Labware LIMS. Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc. Strong analytic, critical thinking and problem-solving skills Attention to detail. Strong Organizational, writing and documentation skills Experience with Agile Methodologies Self-motivated Experience in Pharma Industry preferred with knowledge of cGMP and Laboratory processes Good Communication Skills including fluency in English Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. Who we are: We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for: Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Job Posting End Date: 07/17/2025 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R352353
Posted 1 month ago
130.0 years
0 Lacs
Hyderābād
On-site
Job Description Manager, GLIMS Developer The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role Overview: Join us and be part of our dedicated team that provides support for our Laboratories to improve efficiency, reporting and compliance while improving LIMS Platform stability and useability. This opportunity will also involve working on our Laboratory Transformation program which is a multi-year, phased approach to streamline and standardize our QC labs to prepare each site to a level playing field of maturity for full digitalization which may require other code and configuration skills (e.g. Python, and scientific apps). What will you do in this role: Customize, Configure and Maintain Labware LIMS per Business Requirements. Develop and Maintain Interfaces to Labware LIMS. Perform System Development Lifecycle (SDLC) activities including translation of requirements into Design. Communicate with the Global LIMS Team. Assist with Development and User Acceptance Testing. What Should you have: Bachelor's degree in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field. 3+ years of software development experience with Labware LIMS Basic. Familiarity with Labware basic concepts, including subroutines, calculations, automation scripts, and message engine. Optional experience in other code or configuration software(s). SQL Knowledge to extract data from Labware. Experience in Pharma Industry and cGMP practices. Experience influencing, without direct authority, navigating complex or matrix organizations and successfully networking and forming partnerships with cross-functional teams. Good Communication Skills including fluency in English Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. Who we are: We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for: Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Job Posting End Date: 07/17/2025 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R352356
Posted 1 month ago
130.0 years
0 Lacs
Hyderābād
On-site
Job Description Manager, GLIMS Tester The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role Overview: Join us and be part of our dedicated team that provides support for our Laboratories to improve efficiency, reporting and compliance while improving LIMS Platform stability and useability. This opportunity will also involve working on our Laboratory Transformation program, which is a multi-year, phased approach to streamline and standardize our QC labs to prepare each site to a level playing field of maturity for full digitalization. What will you do in this role: Create and/or support the execution of Development Testing (DT) and User Acceptance Testing (UAT) Test Scripts Create Test Summary Documents Identify and Report test and system Defects. Create and Update validation deliverables such as Requirements, Risk Assessments, Trace Matrices and Test Plans. Develop and maintain good Labware product knowledge Willingness and ability to collaborate/communicate with the Global LIMS Team and Quality Stakeholders. What Should you have: Bachelor's degree and a minimum of 1 years making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field. Experience in software testing, preferably Labware LIMS. Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc. Strong analytic, critical thinking and problem-solving skills Attention to detail. Strong writing and documentation creation skills Self-motivated Familiarity with Agile Methodologies. Experience in Pharma Industry preferred with knowledge of cGMP and Laboratory processes. Good Communication Skills including fluency in English Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. Who we are: We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for: Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Job Posting End Date: 07/17/2025 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R352357
Posted 1 month ago
5.0 years
0 Lacs
Ahmedabad
On-site
Description: The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the lab's continuous development through training and adherence to SOP Essential Functions: Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc. Prepare method development report along with tentative analytical method. Attain method transfer activity. Method validation like Dissolution, Assay, Related compound and Residual solvents etc. Preparation TT report To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory. Preparation of study protocols with respect to Laboratory. Development batch stability analysis as per stability protocols To attain and complete self-training through QMS. Responsible for COA preparation and release of development sample against TRF. Additional Responsibilities: Raise indents, prepare Capex, and manage laboratory inventory. Attend technical workshop /seminar and explore new technique and technology at work place Education: Master Degree (MS/MA) M. Sc - Preferred Master Degree (MS/MA) M. Pharma - Preferred Experience: 5 years or more in 5-7 years Skills: Documentation & Data Review, Interpretation & Statistical Analysis - Intermediate Anlytical Method Development & Validation - Intermediate Good Laboratory Practices (GLP), Data Integrity and Compliance - Advanced Stability Study Management - Advanced Good Documentation Practices (GDP) - Intermediate Electronic Lab Notebook (ELN) Management/LIMS - Advanced Adapts to organizational growth - Intermediate Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Posted 1 month ago
3.0 - 5.0 years
0 Lacs
Ahmedabad, Gujarat, India
On-site
Description JOB DESCRIPTION The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the lab's continuous development through training and adherence to SOP Essential Functions Candidate should have worked at least 3- 5 years in injectable ARD. Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc. Prepare method development report along with tentative analytical method. Attain method transfer activity. Method validation like Dissolution, Assay, Related compound and Residual solvents etc. Preparation TT report To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory. Preparation of study protocols with respect to Laboratory. Development batch stability analysis as per stability protocols Responsible for COA preparation and release of development sample against TRF. Additional Responsibilities Taking responsibility to give training to junior for on job training Attend technical workshop /seminar and explore new technique and technology at work place Education QUALIFICATIONS Master Degree (MS/MA) M. Sc - Preferred Master Degree (MS/MA) M. Pharma - Preferred Experience Minimum 5 years in injectable Skills Documentation & Data Review, Interpretation & Statistical Analysis - Intermediate Anlytical Method Development & Validation - Intermediate Good Laboratory Practices (GLP), Data Integrity and Compliance - Advanced Stability Study Management - Advanced Good Documentation Practices (GDP) - Intermediate Electronic Lab Notebook (ELN) Management/LIMS - Advanced Adapts to organizational growth - Intermediate Specialized Knowledge: Licenses: About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Show more Show less
Posted 1 month ago
0 years
0 Lacs
Jaipur, Rajasthan, India
On-site
Role: Product Executive Role Definition The Product Executive supports in executing product strategies, managing communication with sales teams, monitoring test performance, and coordinating medico-marketing initiatives for focused diagnostic tests (e.g., Autoimmune, Molecular, Oncopathology). This role acts as a key execution arm, ensuring that product initiatives translate into field action and sales enablement across zones. Deliverables Ensure timely implementation of Product Management plans and sales initiatives Support development and communication of scientific, training, and marketing materials Coordinate field-level engagement and training with zonal teams Maintain dashboards, trackers, and reporting tools for product performance Execute monthly content and scientific activity calendars Task And Activities Product Execution & Document Management Maintain and regularly update Test Monographs, FAQs, and Medico-marketing Notes for each focused test based on CoE inputs. Coordinate with CoEs and Laboratory Director to ensure clinical SOPs, TATs, and report formats are available for each product. Track any changes in regulatory/NABL requirements and update product documentation accordingly.. Product Launch & GTM Execution Assist Product Manager in creating GTM task trackers for new test launches — aligned by zone, specialty, and channels (B2C, B2D, B2B). Share pricing decks, test codes, bundled packages with Zonal Sales Managers. Monitor readiness of backend support: LIMS activation, Billing setup, Logistics feasibility, and Phlebo sample protocol. Coordinate with Marketing to print and dispatch test brochures, clinic standees, sample reports, etc. Send weekly progress updates on tasks to the Product Manager for timely execution monitoring. Define internal KPIs – Test volume, Doctors conversion, Campaign reach, etc. Scientific Promotion & Doctor Engagement Maintain and circulate a Monthly Scientific Promotion Calendar based on test priorities. Track doctor responses and objections from sales team groups and update the Objection Tracker. Coordinate logistics for RTM/ CME planning — venue booking, slide deck preparation, attendance, and doctor feedback collection. Maintain a KOL master tracker for each test category and ensure engagement via meets or roundtables. Assist in building visual tools such as medico-marketing scripts, FAQs, and interpretation slides for field usage Sales Enablement & Training Coordination Coordinate E-Gurukul training schedules, attendance reports, and test completions for sales team members. Schedule and record virtual sessions for new test/ products in collaboration with L&D. Prepare product training kits with talking points, pitch scripts, and value propositions for focused tests. Share weekly test focus mailers for doctor conversion to sales teams through internal groups. Track feedback from joint field working reports and ensure issues raised (pricing, report quality, etc.) are closed with respective departments. Performance Tracking & Dashboard Management Maintain and update a Product Performance Dashboard: test-wise, zone-wise, volume and contribution achievement, and new doctor conversions. Monitor prescription conversion for scientific tests and flag low-performing zones for intervention. Track campaign performance using data from dashboards, and field feedback; prepare a monthly impact summary. Consolidate test-wise feedback from field visits and review meetings into an Action Closure Tracker. Assist Product Manager in preparing Monthly Product Review Decks for meetings Success Metrics 100% completion of Product Launch tasks as per timelines Achieve 100% revenue targets for the assigned product. 4.8 customer satisfaction scores and positive feedback from customers. 30% Engagement of MSL through scientific programs 100% management and availability of documentation & sales collaterals Show more Show less
Posted 1 month ago
3.0 years
0 Lacs
Pune, Maharashtra, India
On-site
About CrelioHealth Careers 2025 We at CrelioHealth believe that “Human minds & technology converge to drive evolution.” CrelioHealth philosophy is based on “IDEA+” Innovate, Deliver excellence, Experience evolution, & Automation. The ‘+’ symbolizes our dedication and continuity to develop & build solutions with you at the center. Take control of your lab operations and simplify lab management. With Our solutions CrelioHealth Patient Engagement, LIMS, PACS, & Inventory management platform. Crelio started with best-in-class cloud-based LIS and RIS platforms. After analyzing the medical diagnostic industry for years after inception, we have expanded our solutions in the areas that matter and affect the medical laboratories & diagnostic businesses more Candidates Also Search: Software Engineer Jobs CrelioHealth Careers 2025 Details Company Name CrelioHealth Job Role Junior Software Developer Job Type Full Time Job Location Pune Education BE/ B.Tech/ B.Sc/ BCA/ ME/ M.Tech/ M.Sc/MCA Career Level 1 – 3 Years Salary Not Mentioned Company Website www.creliohealth.com Job Description For CrelioHealth Careers 2025 Candidates Also Search: Fresher Jobs Design, build and maintain efficient, reusable Python code. Improve the functionality of the existing system. Design and write highly efficient complex algorithms. Ability to work with REST APIs, and experience in using 3rd party APIs Familiarity with version control systems like Git. Ability to adapt to a fast-paced environment and be able to work, both independently and in a team. Write unit tests to check code regressions and edge cases. Candidates Also Search: BE/ B.Tech Jobs Job Specifications Strong problem-solving skills. Excellent debugging and optimization skills Familiarity with databases and reporting will be a plus. Familiarity with Python and Python frameworks like (Django, Flask etc.) will be a plus. Familiarity with JavaScript, ES6 and front-end technologies like (React and Angular) will be a plus. Capable of handling web service integration – RESTful, JSON Motivation and drive to work in a start-up environment. CrelioHealth Careers 2025 Application Process DOUBLE CLICK TO APPLY ONLINE ! We wish you the best of luck in your CrelioHealth Careers 2025 . May your talents shine, and may you find the perfect opportunity that not only meets your professional goals but also brings joy to your everyday work. Show more Show less
Posted 1 month ago
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