Get alerts for new jobs matching your selected skills, preferred locations, and experience range. Manage Job Alerts
5.0 - 10.0 years
0 Lacs
Gautam Buddha Nagar, Uttar Pradesh, India
On-site
Role: Tulip Sales Engineer Sr Manager Location: Noida | Hybrid Employment Type: Full-time Background Algoworks is creating a practice for Tulip. The technology platform is the leader in frontline operations for the manufacturing industry. It is a low code/no code application enabling the clients workforce to connect apps with information and guidance on the assembly line. The benefit for clients is getting higher quality work, improving efficiency, and improved visibility with end-to-end traceability across operations. This role will collaborate with other Algoworks teams to help create offers, win new clients, deploy solutions, and grow the business. Ideally, Tulip experience is a big plus, but not mandatory. Skills/Experience Desired You have experience in Manufacturing or Industrial operations. You are passionate about Digital Transformation and are focused on driving value for clients. You are always looking at ways to improve solutions, implement best practices, and improve our methodology and quality of execution within the Digital Transformation Engineering Team. You are a natural team player that understands what it is to work in an agile environment. BS degree in Engineering (Mechanical, Industrial, Chemical, Computer Science). MSC degree is a plus. 5-10 years of enterprise SaaS presales experience. 10 years of valuable experience in Manufacturing or Industrial operations. Experience in selling to or working with manufacturing companies to help them with their digital transformation journey. Excellent business writing, presentation, and communication skills. You can speak, write, and comprehend the English language fluently. Preferred experience with systems such as MES/MoM, LES/LIMS, WMS, QMS, ERP, SPC, IIoT, etc. Team player with strong interpersonal skills and the ability to take a leadership role to eventually manage a team. Have passion for technology and speak fluently about current trends related to SaaS, PaaS, IIoT, and cloud solutions. Detail-oriented individual with the ability to quickly assimilate and apply new concepts, business models, and technologies. Travel: Please note this role will involve some travel between 10-50 PERCENT depending on demand. Location: This role is based in India. Working hours: This role initially supports the Indian and US markets. Our normal hours are 3a-12p Eastern Time Zone which allows overlap with the US prospects. Flexibility is a plus to make afternoon meetings in the US. Key Responsibilities: In order to succeed, you will: Consult customers and prospects to prepare their companies for digital transformation. Work closely with our sales team to effectively progress opportunities through the pipeline and secure the technical win. Develop, present, and deliver high-impact technical demonstrations of the Tulip solutions daily (Demos, technical presentations, technical discussions, etc.). Clearly articulate the benefits of Tulips applications to all levels including but not limited to line of business managers, C level executives, and IT. Provide comprehensive technical presales support. Identify and collaborate with prospects technical stakeholders to align around Tulips solution and secure commitments needed to ensure a technical close. Manage and maintain internal requests using our internal systems. Facilitate brainstorming sessions and consensus building. Perform needs gathering and requirement analysis for new customers. Analyze and track reseller competencies and technical delivery. Help develop and answer RFx (RFI, RFP, RFQ), technical assessments, technical and security questionnaires. Lead in the scoping and estimation of implementation. Show more Show less
Posted 2 months ago
0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Position We are seeking a LabVantage LIMS Administrator to support the Pilot Bioproduction Facility. (ONLY apply if you have expertise in configuring and troubleshooting Labvantage LIMS) Responsibilities This independent self-starter will be asked to set up Labvantage LIMS for this burgeoning highly technical pharmaceutical/ med device clients and training SysAdmins to use LV LIMS in regulated GxP IT environments. This candidate: Leads LIMS implementation projects, ensuring adherence to project timelines and budgets. Collaborates with stakeholders to gather requirements and design effective LIMS solutions. Configures LabVantage to meet specific business needs, including workflows, security settings, and reporting. Oversees the creation, maintenance, and accuracy of master data within the LIMS system. Customizes and configures LabVantage modules, workflows, and reports to fit the laboratory's unique requirements. Develops and implements data governance policies and procedures. Ensures data integrity and consistency across the organization. Provides end-user support for quality control activities, including data validation, review, and approval processes. Assists in the development and implementation of quality control standards and procedures. Monitors and troubleshoots quality control issues. Performs routine maintenance, updates, and upgrades to the LabVantage LIMS to ensure optimal performance and reliability. Identifies potential risk and mitigation strategies. Coordinates with cross-functional teams to ensure project success. Provides technical support to end-users, resolving issues and answering questions related to LabVantage functionality. Maintains and updates LIMS documentation and training materials. Stays current with the latest LabVantage updates and best practices. Manages application vendor support agreements. Qualifications Bachelor's degree in Computer Science, Information Technology, or a related field, and ten (10) years of relevant experience Minimum of five (5) years of experience in LabVantage 8 LIMS coding, development, and implementation. CGMP Quality Control, Environmental Monitoring, or Manufacturing experience. Experience in laboratory environments and understanding of laboratory workflows. Strong understanding of LIMS implementation methodologies and best practices. Familiarity with LabVantage LIMS architecture and database schema. Demonstrates proficiency in master data management and data governance principles. Excellent problem-solving and troubleshooting skills. Strong communication and interpersonal skills. Ability to work independently. Preferred Certifications in LabVantage or related LIMS technologies. Experience with LIMS validation and compliance requirements. Knowledge of scripting languages (e.g., Python, SQL). Experience with other cGMP or biopharmaceutical software applications. Show more Show less
Posted 2 months ago
1.0 - 6.0 years
4 - 7 Lacs
Ahmedabad
Work from Office
Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.
Posted 2 months ago
5.0 - 8.0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
Job Summary (ISG) We are seeking a Sr Analyst with 5 to 8 years of experience to join our team. The ideal candidate should possess deep technical knowledge in SampleManager LIMS applications to effectively guide the team and troubleshoot complex issues. Analyzes and resolves intricate technical problems often collaborating with onshore teams for guidance or escalation. Coaches and mentors team members fostering a culture of continuous learning and skill development. Responsibilities Possesses deep technical knowledge in SampleManager LIMS applications to effectively guide the team and troubleshoot complex issues. Analyzes and resolves intricate technical problems often collaborating with onshore teams for guidance or escalation. Coaches and mentors team members fostering a culture of continuous learning and skill development. Promotes knowledge sharing within the team through documentation training sessions and regular communication. Estimate the effort resources required and the cost for the major changes that will be delivered under a new SoW. Implement the minor enhancement following the stipulated Change Control process. Coordinate with the development team on the Release deployment and hypercare. Identify the fixes for the defects discovered by the support team and hand it over to the development team for further testing and deployment. Team Management: Manages team resources effectively assigning tasks based on bandwidth. Process Management: Identifies opportunities to improve support processes reducing resolution times and enhancing customer satisfaction. Oversees incident management processes ensuring timely resolution and root cause analysis. Manages changes to the support environment minimizing disruptions and ensuring smooth transitions. Communicates effectively with clients providing regular updates on incident status and resolution efforts. Escalates critical issues to appropriate stakeholders ensuring timely resolution and minimizing impact. Strives to exceed client expectations delivering high-quality support and building strong relationships. Show more Show less
Posted 2 months ago
0 years
0 Lacs
Greater Kolkata Area
On-site
Project Manager profiles with Life Science background for LAB COE.-13yrs-20yrs Job Description Has Provided Below For Your Reference Develop and control Project plan, budgets and activities Experience in change, risk and resource management Implementing and managing changes and interventions to ensure project goals are achieved. Producing accurate and timely reporting of program status throughout its life cycle. Proven experience in program management. Proven stakeholder management skills. Proven experience managing a team. Preferably have Lab Informatics/LIMS/ automation services background Nice to Have experience in driving at least one LIMS/CDS project / program and familiar with IQ/OQ/PQ and SDLC Experience in leading diverse teams, experience of cultivating and collaborating in a multi-cultural environment. Experience with the Agile methodology. Show more Show less
Posted 2 months ago
2.0 - 7.0 years
1 - 6 Lacs
Noida
Work from Office
We're Hiring! Join ITDOSE INFOSYSTEMS! We are looking for passionate and result-oriented International Business Development Managers (BDMs) and Sr. Executives to expand our footprint in the HIMS (Healthcare Information Management Systems) and LIMS (Laboratory Information Management Systems) markets across Overseas (For North Africa countries like Morocco, Algeria and Tunisia) Experience: Must have 2-9 years in the International IT Sales ( Preferred in ERP Sales) Location: Base Location Noida But Have to Travel Overseas (Quarterly) Why Join Us? Competitive compensation Lucrative incentives and bonuses Career growth opportunities Dynamic work environment Preferred: Male Candidates with prior experience in HIMS or LIMS domains, Software Product Sales. Interested? Apply now! Email your resume to: anita.yadav@itdoseinfo.com WhatsApp us: +91-9289552164 Take the next big step in your career with ITDOSE INFOSYSTEMS! Role & responsibilities • Research and generate lists of potential customers. • Provide input on customer briefs, presentations, and sales literature. • Develop and implement International business development strategies to expand the company customer base and increase revenue. • Identify and pursue new International business opportunities, such as partnerships, alliances, and collaborations. • Conduct market research to identify customer needs, market trends, and competitive landscape. • Manage the International sales process, including lead generation, qualification, proposal development, and contract negotiation. • Work closely with the product development team to ensure that customer feedback and market trends are incorporated into product design and development. • Monitor International sales and revenue performance against targets and adjust business development strategies as needed. • Provide regular reports and updates on International business development activities to senior management. • Selling & demonstrating services to International clients or other businesses in Healthcare Domain. • Manage and update company database and customer relationship management systems (CRM).
Posted 2 months ago
3.0 - 8.0 years
0 Lacs
Greater Kolkata Area
On-site
Job Summary We are seeking a skilled Analyst with 3 to 8 years of experience in Validation and Testing in Labware LIMS Labvantage LIMS GLIMS CDS and any Lab Systems. Responsibilities Experience/ exposure to Computerized System Validation (CSV) US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5. Experience of CSV Validation in any one of the Lab systems (LIMS CDS SDMS etc) is must. Should worked in pharmaceutical domain and its related knowledge is must Good communication and technical writing skills are a must Developing validation documentation for pharmaceutical equipment facilities and computerized systems used in GLP GMP and GCP environments. Project Deliverables will encompass validation plans specifications test protocols and standard operation procedures and systems may include Process Automation Laboratory Automation Enterprise IT Applications and Network Infrastructure. CSV GAMP 5 CPFR Part 11 Validation Worked in V model SOP & SDLC Lifecycle To provide a planned approach for the implementation of the CSV deliverables migration due diligence GXP and Non GXP areas Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement. Prepare and execute SCA URS MVP VP RTM TP IQ OQ PQ VSR Traceability Matrix FRA / FEMA Exposure to Regulatory Audits The service will benefit if knowledgeable about and capable of advising on product & ingredient regulation within the industry (not mandatory). Using previous use cases and best practice counsel on highly regulated environments Ensure the CSV artefacts are in line and meets regulatory requirements Preferred Experience in Agile Development Knowledge on working in Jira / Service Now Certifications Required ISTQB Certified Tester Certified Software Quality Analyst (CSQA) Show more Show less
Posted 2 months ago
0 years
0 Lacs
Greater Kolkata Area
On-site
Job Summary Proven experience in project / program management. Develop and control Project plan budgets and activities Experience in change management risk and resource management are must. Implementing and managing changes and interventions to ensure project goals are achieved. Producing accurate and timely reporting of project / program status throughout its life cycle. Proven stakeholder management skills. Preferable to have Lab Informatics or Life Sciences domain background. Responsibilities Proven experience in project / program management. Develop and control Project plan budgets and activities Experience in change management risk and resource management are must. Implementing and managing changes and interventions to ensure project goals are achieved. Producing accurate and timely reporting of project / program status throughout its life cycle. Proven stakeholder management skills. Preferable to have Lab Informatics or Life Sciences domain background. Nice to Have experience in driving at least one LIMS/CDS project / program and familiar with GxP validation processes. Experience with the Agile methodology CSM/CSPO certification will be a plus. Certifications Required PMP CSM Show more Show less
Posted 2 months ago
10.0 years
0 Lacs
Pune, Maharashtra, India
On-site
Role Overview: Experienced Solution Architect to design and deliver scalable, compliant, and innovative solutions within the Life Sciences domain. Will work closely with stakeholders across R&D, Clinical, Regulatory, and Commercial functions to architect systems that meet business goals while ensuring adherence to regulatory standards such as GxP and 21 CFR Part 11. Key Responsibilities: Solution Design & Architecture: Architect end-to-end Life Sciences solutions, including system integrations, data workflows, and cloud enablement. Create high-level and detailed solution blueprints for platforms such as Veeva, SAP, LIMS, and other clinical/quality systems. Stakeholder Collaboration: Engage with business and IT teams to translate clinical, regulatory, and commercial needs into secure, scalable technical architectures. Regulatory Compliance: Ensure architectural solutions align with GxP, HIPAA, and 21 CFR Part 11 requirements. Support audit readiness and validation documentation. Technical Leadership: Guide engineering teams through design, development, and implementation. Align technology strategy with business outcomes. Documentation & Governance: Produce architecture documents, interface specifications, and compliance checklists. Participate in solution reviews and change control. Preferred Qualifications: 10+ years in IT with 3–5 years in Solution Architecture roles Experience in Life Sciences/Pharma/MedTech across functions (Clinical, Regulatory, Quality, etc.) Strong knowledge of SDLC, Agile/Waterfall, API/Microservices, Cloud (Azure/AWS) Familiarity with platforms like Veeva Vault, SAP, LIMS, and EDC tools Working knowledge of data integration standards (e.g., HL7, FHIR) Strong understanding of compliance standards (GxP, 21 CFR Part 11) Excellent communication and stakeholder management skills Show more Show less
Posted 2 months ago
1.0 - 6.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Conduct quality control tests on raw materials, intermediates, and finished products using techniques such as HPLC, GC, FP, IP, Stability studies. Ensure compliance with cGMP guidelines and maintain accurate records of testing results. Investigate market complaints and perform microbiological analysis to identify root causes. Develop and implement quality assurance procedures for OSD formulations. Collaborate with cross-functional teams to resolve issues related to dissolution testing.
Posted 2 months ago
2.0 years
0 Lacs
Pune, Maharashtra, India
On-site
This role is part of ADS’s Global Technical Organization (GTO). GTO delivers world-class analytics and digital solutions on Ecolab’s Product Quality, Process Safety & Sustainability landscape. The team is responsible to maintain the highest quality standards by tracking performance metrics, identifying quality issues, and driving continuous improvement. Are you a driven individual with a passion for data and analytics? We're looking to hire an Analyst (GTO) to join our Global Supply Chain Analytics team in Pune, India. In this role, you’ll be responsible for leading initiatives in Digital Twin, Enterprise Quality KPIs, and to provide support in functional product deployments and maintenance. You’ll work closely with the quality functional stakeholders, data engineering and design teams to co-create quality products and solutions to get them design reviewed before of formal product launch. You’ll also serve to bring functional thought leadership and industry best practices for experimentations and deployments. What You'll Do Data Collection & Integration Gather and integrate data from manufacturing systems, supply chain platforms, and IoT devices using OSI PI. Ensure real-time data availability, reliability, and accuracy to support operational needs Configure and maintain data points, historians, and visualization tools. Data Analysis And Visualization Utilize Seeq for advanced data analytics and trend analysis to identify patterns and root causes of inefficiencies as well as analysis on various quality indicators. Create dashboards, reports, and KPIs using PowerBi, Redzone to provide actionable insights to stakeholders. Work closely with process engineers/plant managers to identify and manage process bottlenecks and drive operational efficiency. Product Development and Deployment Work on various plant-level process efficiency improvement, automation and controls and Digital Twin projects like Aveva, Redzone among others. Leverage product quality methodologies like Capable / non-capable specs, spec deviations, supplier quality audits and assessments for overall Quality KPIs, root cause analysis (RCA), CAPA and Supplier Corrective Actions (SCAR). Functional Knowledge Management Contribute to knowledge management and continuous improvement initiatives. Partner with cross-functional teams to ensure successful project delivery. Stay updated on the latest developments in supply chain technologies and provide recommendations for system upgrades or integrations Act as a subject matter expert on OSI PI, Seeq, and Redzone, providing training and support as needed. What You Bring Bachelor's degree in chemical, mechanical engineering, computer science, information systems, or a related field (advanced degree a plus). 2+ years of experience in quality foundations and philosophies like 8D, problem solving, statistical process control (SPC), RCA, process capability, value stream mapping and six sigma principles. Good to have – six sigma green belt certification, data historians like OSI PI, & real-time analytics tools like Seeq, Redzone. Knowledge of Digital Twins, LIMS Understanding of Manufacturing Key Performance Indicators. Excellent analytical and quality problem-solving skills with a keen eye for detail. Entry-level exposure to technical skills in visualization using MS Power BI and familiarity with programming skills in Python and M language Good to have exposure in cloud platforms (Azure / AWS) and data management in SQL querying and SAP tables/transactions, Snowflake Strong communication and collaboration skills. Ability to thrive in a fast-paced environment and manage multiple projects. What’s In It For You Opportunity to join a growth company offering competitive compensation and benefits. The ability to make an impact and shape your career with a company passionate about grooming talent for creating future leaders. The support of an organization that believes it is vital to include and engage diverse people, perspectives, and ideas to achieve our best. Feel proud daily to work for a company that provides clean water, safe food, abundant energy and healthy environments. Our Commitment to Diversity and Inclusion Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability. Show more Show less
Posted 2 months ago
7.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Summary Biomedical Research (BR) is the global pharmaceutical research organization of Novartis. With approximately 6,000 scientists and physicians around the world, our research is focused on discovering innovative new drugs that will change the practice of medicine. We have an open and entrepreneurial culture, encouraging collaboration to make effective therapies. At BR, our mission is to discover innovative medicines that treat disease and human health. To do that, our scientists need cutting-edge, state-of-the-art computing systems. With Research Informatics (RX), BR is making a strategic investment into informatics capabilities and is positioning itself to deliver the systems and services that are critical to the future of drug discovery. Purpose Of The Role Novartis’ Biomedical Research (BR) Informatics (RX) group is establishing a strong presence in India, and we are seeking proactive and versatile professional in the role of Software Product Operations Manager for supporting Pre-Clinical and Clinical systems . As an IT Product Operations Manager (POM) you will co-lead and manage, together with a Product Manager and a Tech Lead, complex, globally deployed, high-impact software solution. you are accountable for all aspects of the software operations from providing operational perspective to product roadmaps, user-support & communication, planning & communicating operational maintenance cycles, maintaining stable & secure systems, increasing the value and operational excellence of the product. About The Role Key Responsibilities: Responsibilities As a co-lead and a member of a cross-functional, matrixed team, consisting of software and data engineers, business analysts, designers and supporters, your primary responsibilities will include: Owning all aspects of operations for one or more software applications within our product team, including stable operations and infrastructure Mitigating operational risks and manage incident detection and resolution Manage incidents, problem and change management and troubleshooting, Providing end-user support, communication, knowledge-base documentation, and trainings Leading vulnerability management efforts, ensuring security, compliance, usability, performance, and sustainability requirements are met Ensuring license compliance, applying application patches, and managing roll-out of upgrades Guiding and coordinating small teams of external application supporters, ensuring effective prioritization of operational activities delivery, Monitoring key system performance metrics and facilitating operational excellence of the product Ensuring adherence to Novartis global Information Security and Quality standards and policies for all products/services. Ensuring compliance with company standards & policies (e.g., Good Laboratory Practice (GLP) & Good Clinical Practice (GCP)) Ensuring operational activities and outcomes are reflected on product roadmaps Engaging with other product teams within and across product lines to leverage operational synergies Working experience Essential Requirements Experience in scientific application support and maintenance in pharmaceutical industry Experience in a drug discovery, scientific research, pre-clinical or Clinical setting preferred Prosses broader knowledge of basic IT architecture on Windows, Linux OS, web service, network etc Good troubleshooting skills and customer focused. Good working knowledge of application deployments Working experience with LIMS and sample management system Working experience with database, Oracle and MSSQL, SQL and PL/SQL Good understand of support model with incident, problem and change management Familiarity with Agile software development and SDLC and ITIL Awareness of authentication protocols Knowledge of cloud environment and services (AWS - Amazon Web Services, Azure, SaaS) Knowledge of AI principles Good understanding of CSV (Helpful to have a GxP understanding). Highly collaborative, proven experience as a team player Strong communication skills Education And Qualification Requirements 7+ years relevant subject matter expertise, obtained through experience or education in software support or operations in a complex environment Bachelor's degree in a technology or scientific subject Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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 2 months ago
4.0 - 5.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
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 sLIMS Implementation Specialist will be responsible for the successful deployment, configuration, and ongoing support of our Laboratory Information Management System (SLIMS). This role requires a deep understanding of laboratory workflows, strong technical skills, and the ability to work closely with cross-functional teams to ensure the SLIMS meets the needs of the organization. Roles and Responsibilities • Support in implementation and configuration of the sLIMS, ensuring alignment with laboratory workflows and regulatory requirements. • Execute the tasks defined in project plans, adhering to timelines, for successful implementation of sLIMS. • Configure sLIMS software to meet the specific needs of the laboratory, configuring workflows, and setting up user roles and permissions. • Provide training and support to end-users, ensuring they are proficient in using the sLIMS. • Troubleshoot and resolve any issues related to sLIMS performance, functionality, and integration with other systems/instruments. • Maintain comprehensive documentation of the sLIMS implementation process, including user guides and technical manuals. • Shall be aware about documentation of sLIMS application as per GMP. Shall be able to create and manage documentation of sLIMS 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 sLIMS implementation, preferably in a pharmaceutical or biotech environment. • Strong understanding of laboratory processes and workflows. • Proficiency in sLIMS software (Expertise on CaliberLIMS is preferred) • Ability to manage multiple tasks 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 SLIMS • 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 Show more Show less
Posted 2 months ago
4.0 - 5.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
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 Show more Show less
Posted 2 months ago
4.0 - 5.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
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 users’ expectation 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 Show more Show less
Posted 2 months ago
0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Company Description At ProvenTech, we are leaders in digital innovation, specializing in development, implementation, and support for the Life Sciences and Healthcare sectors, including pharmaceuticals, biotech, and nutrition. Our expertise lies in revolutionizing manufacturing processes with Industry 4.0 and Pharma 4.0 technologies, driving productivity and operational efficiency. We design and deliver secure, scalable, and stable systems tailored to unique business needs, providing end-to-end solution architecture for sustainable growth. Our customer-centric approach, combined with cost-effective solutions and domain expertise, ensures that we deliver products aligning with clients' vision, empowering them to achieve success. Role Description We are seeking a highly motivated and detail-oriented individual to join our team as a LIMS Master Data Creation Specialist. In this role, you will be responsible for the accurate and timely creation and maintenance of master data within our LIMS platform. The successful candidate will possess a strong understanding of laboratory workflows and data management principles, along with excellent organizational skills and the ability to work independently and collaboratively within a team environment. Key Responsibilities: Utilize knowledge of laboratory processes and terminology to accurately translate requirements into LIMS master data configurations. Collaborate with laboratory staff and project stakeholders to gather requirements for master data creation and ensure alignment with business needs. Configure LIMS system settings, including sample types, test methods, analytical procedures, and other relevant parameters. Input and validate data in accordance with established Procedures and quality standards. Perform routine data maintenance tasks, including updates, corrections, and archival of obsolete data. Troubleshoot Master data-related issues and provide timely resolution to ensure system integrity and reliability. Document master data creation processes, standard operating procedures (SOPs), and system configurations. Provide training and support to end-users on master data management best practices and system usage. Collaborate with cross-functional teams, including IT, quality assurance, and laboratory operations, to support system integration and enhancement initiatives. Stay informed about industry trends and emerging technologies related to laboratory informatics and master data management. Show more Show less
Posted 2 months ago
0 years
0 Lacs
India
Remote
SAP Master Data Expert - 6 months - Contract - Full time - Remote with AdHoc Travel We are seeking a meticulous and collaborative SAP Master Data Expert with functional business experience in SCM and MM to support enterprise-wide data transformation initiatives within the pharmaceutical sector. This role plays a critical part in ensuring the integrity, compliance, and readiness of master data—particularly in regulated domains such as manufacturing, quality, regulatory, and clinical systems. You will work closely with IT, regulatory affairs, quality assurance, and business stakeholders to ensure seamless data migration from legacy systems to validated platforms. Key Responsibilities Data Preparation & Governance Collaborate with IT and country-level Business Data Owners to identify in-scope data objects, including product, material, batch, and regulatory data. Maintain and govern master data lists for assigned objects, ensuring alignment with GxP and data integrity standards. Support the development of value mappings and data transformation rules in collaboration with technical teams. Provide domain-specific business insights to guide data extraction and conversion from legacy systems. Data Quality & Compliance Execute data cleansing activities in accordance with project timelines and regulatory expectations (e.g., ALCOA+ principles). Validate data quality throughout the migration lifecycle, ensuring compliance with internal SOPs and external regulatory requirements (e.g., FDA, EMA). Approve and execute data verification scripts to ensure completeness, consistency, and traceability. Data Migration & System Readiness Collect and prepare data for manual or construction-related objects, including those in manufacturing execution systems (MES), LIMS, or ERP platforms. Approve upload files pre- and post-load, ensuring formal documentation and audit readiness. Perform manual data entry and dual maintenance where required, particularly in validated systems. Hypercare & Issue Resolution Act as the Single Point of Contact (SPoC) for assigned data objects during Hypercare, supporting issue triage and resolution. Collaborate with QA and IT to manage data-related defects and ensure timely remediation in line with change control procedures. Key Performance Indicators (KPIs) Regulatory-Grade Data Cleansing : Completion of data cleansing activities in accordance with project timelines and compliance standards. Validated Data Loads : Successful and audit-ready data loads into GxP systems, aligned with migration schedules. Issue Resolution Efficiency : Timely resolution of data quality issues, with full documentation and traceability. Qualifications Experience in data migration or master data management within the pharmaceutical or life sciences industry. Expertise in Supply Chain Management(SCM) and Material Management/Master Modules(MM) within SAP in a Functional or Hands off capacity Familiarity with GxP, ALCOA+ principles, and regulatory data standards (e.g., IDMP, SPOR, ISO IDMP). Proficiency with data tools and validated systems (e.g., SAP, Veeva Vault, LIMS, TrackWise). Strong analytical, documentation, and stakeholder communication skills. Understanding of data governance frameworks and regulatory compliance requirements. If you feel this role is a good fit for you - Contact me on sozay@redglobal.com or Apply within! Show more Show less
Posted 2 months ago
1.0 - 3.0 years
0 Lacs
Ahmedabad, Gujarat, India
On-site
Job Description Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instrument's / equipment's . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instrument's / equipment's. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity. Qualifications Qaulification # B.Sc./M.Sc. Experiance # 1-3 Years Desigantion # As per company Policy 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 2 months ago
3.0 - 5.0 years
0 Lacs
Hyderabad, Telangana, India
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Data Scientist II, BIA GPS India Operations Summary The Data Scientist II will play a crucial role in supporting operational analytics across GPS to ensure products continue to serve most pressing GPS analytics needs, with potential opportunities to build new advanced analytics capabilities such as predictive modelling, simulation, and optimization. The Data Scientist II should have a strong interest in solving business problems, and an eagerness to work on all parts of the analytics value chain, from partnering with IT on data pipelines to operationalizing analytics in the service of our patients around the world. Roles & Responsibilities Conduct analysis and interpretation of complex data sets to derive meaningful insights and recommendations based on an understanding of GPS priorities, critical issues, and value levers. Collaborate with stakeholders to identify business problems, goals, and KPIs to to design, establish and maintain data pipelines, models and business facing reports and dashboards. Design, develop, and implement a broad array of GPS analytics that solve complex problems in a computationally efficient and statistically valid manner. Identify and implement enhancement and automation of high-value analytics while ensuring they continue to function efficiently. Collaborate proactively with IT teams to develop and enhance data infrastructure, data pipelines, and analytical tools for efficient data collection, processing, and analysis. Prepare reports, dashboards, and presentations to communicate analyses to stakeholders at various levels of the organization. Follow technical best practices in building, maintaining, and enhancing analytics output with scalable solutions, including code version control, pipeline management, deployment, and documentation. Provide training, guidance, and mentorship to junior analysts and team members when required. Work hours that provide sufficient overlap with standard east coast US working hours. Skills and competencies Strong analytical thinking and problem-solving skills with the ability to analyse complex data sets and draw meaningful conclusions. Agile problem-solving ability and desire to learn new things and continuously improve. Proficiency in statistical analysis techniques and methodologies. Strong project management skills and the ability to work independently or as part of a team. Solid understanding of digital analytics tools and platforms and version control. Strong communication skills with the ability to present complex information to non-technical stakeholders in a clear manner. Strong business acumen and strategic thinking, with the ability to translate analytical findings into actionable insights and recommendations. Experience Bachelor's or Master's degree in an analytical, engineering, operations research or scientific discipline. Proven experience (typically 3-5 years) in a data and analytics role, including direct development experience. Experience working with large datasets, data visualization tools, statistical software packages and platforms (specifically R, Python, advanced SQL, Domino, AWS, GitHub, dbt, Tableau) Experience with major GPS applications (SAP, Oracle, LIMS, Infinity, MES) is a plus. Experience with biotech product development, manufacturing operations, supply chain, and quality control is a significant plus. Experience in the biopharma industry a plus. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less
Posted 2 months ago
0 years
0 Lacs
India
On-site
Job description Job Title: Siemens Opcenter Pharma Execution MES Specialist Location: Chennai or Pune (Hybrid) Notice: Immediate Joiners( 0- 30 days only consider ) Job Type: Full-Time We are seeking a skilled MES Specialist with hands-on experience in Siemens Opcenter Execution Pharma to support digital transformation in pharmaceutical manufacturing. The ideal candidate will help implement, configure, and optimize MES solutions to ensure compliance, efficiency, and data integrity. Responsibilities: Configure and deploy Siemens Opcenter Pharma MES solutions. Design and implement Electronic Batch Records (EBRs). Integrate MES with ERP, LIMS, and automation systems. Support system validation in compliance with GMP and 21 CFR Part 11. Troubleshoot MES issues and provide user support. Requirements: Proven experience with Siemens Opcenter Pharma MES. Strong understanding of pharmaceutical manufacturing processes. Familiarity with GMP regulations and GAMP 5. Experience with MES-ERP integration (e.g., SAP). Excellent problem-solving and communication skills. Show more Show less
Posted 2 months ago
0 years
0 Lacs
Chakan, Maharashtra, India
On-site
Position Overview: We are seeking a dedicated and experienced Quality Control Analyst to join our pharmaceutical team. The ideal candidate will be responsible for ensuring the highest quality standards in our analytical processes, documentation, and laboratory operations. Key Responsibilities: Analyst Qualification & Training: Oversee the qualification process for analysts. Conduct and coordinate training programs for QC employees to ensure compliance with current standards and practices. Documentation Management: Prepare and review critical documents, including Specifications, Standard Testing Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Transfer Protocols (MTP), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR). Analytical Data Review: Review analytical data for routine samples, including in-process samples, Drug Substance (DS), Drug Product (DP) release, and stability samples. Oversee method transfer and method validation processes. Reference Standards & Material Management: Manage reference standards and oversee the indenting process for materials required in QC. Calibration Coordination: Coordinate with external vendors for instrument calibration. Collaborate with QC personnel for in-house calibration and verification of laboratory instruments. Laboratory Equipment Maintenance: Ensure proper maintenance and management of laboratory equipment and instruments to guarantee optimal performance. Method Validation & Transfer: Manage activities related to method validation and method transfer to ensure accurate and reliable analytical results. Quality Incident Management: Initiate and investigate incidents, deviations, change controls, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA), and Out of Trend (OOT) findings. Analysis Planning: Plan and schedule analyses for Drug Substance (DS), Drug Product (DP), stability studies, and protocol-based samples. Technical Expertise: Proficient in handling High-Performance Liquid Chromatography (HPLC) instruments, including Reverse Phase HPLC (RP-HPLC). Experience with Laboratory Information Management Systems (LIMS). Skilled in using chromatography data systems such as Chromeleon and Empower 3. Familiarity with Cation Exchange Chromatography (CEX) techniques. Qualifications: Master’s degree in Chemistry or a relevant field. Minimum of [Insert Number] years of experience in a pharmaceutical quality control laboratory. Strong understanding of cGMP, GLP, and regulatory requirements. Excellent analytical and problem-solving skills. Effective communication and teamwork abilities. Show more Show less
Posted 2 months ago
3 - 7 years
0 Lacs
Ahmedabad, Gujarat, India
On-site
Job Description JOB DESCRIPTION Analysis and release of RM, PM, IP and FP Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KF titrator. Knowledge of Chemical analysis. Knowledge of LIMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Knowledge of QMS Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department. Qualifications Education: B.Sc., M.Sc., B.Pharma, Total Experience - 3 - 7 Year in QC department of sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role. Show more Show less
Posted 2 months ago
3 - 7 years
0 Lacs
Ahmedabad, Gujarat, India
On-site
Job Description Analysis related to qualification of Instrument/Equipment and Standards Qualification of Standards and Instruments Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KF titrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Testing of Miscellaneous Material, in-process, finished product and stability samples (as per stability protocol) To ensure the timeline for initiation and completion of testing. To keep update of instruments logbooks and to record the data in LNB during testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department Qualifications Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 7 Year in QC department of sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role. Show more Show less
Posted 2 months ago
7 years
0 Lacs
Hyderabad, Telangana, India
On-site
Summary The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures. eCompliance Manager provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects. About The Role Location – Hyderabad Key Responsibilities Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. Review and approve the GxP Changes and the associated deliverables. Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented. Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. Perform supplier qualification assessment activities. Provide Audit support as assigned and in case of CAPAs, provide the required Quality support. Essential Requirements xP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements. On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems. Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues. Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported. Client/stakeholder satisfaction and corresponding feedback. Desirable Requirements 10-15 years of overall IT experience, and a minimum 7 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.) Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments Experience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.) Successful cross-divisional/functional work with complex international teams Experience in GxP supplier qualification activities Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Ability to effectively interact and present to Management Ability to manage the key stakeholders and build trust Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, negotiation, facilitation, and interpersonal skills Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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 2 months ago
4 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
LabWare Developer JD LabWare Developer with work experience of at least 4 years and responsibilities that include: Gathering user requirements to understand the needs of the laboratory and stakeholders. Configuring LabWare LIMS and providing technical assistance to the team and troubleshooting when needed. Configuration and creation of Master Data including but not limited to Products, Projects, Analysis, Calculations, Automation Scripts, Message Engine etc. Good knowledge of LIMS Basic – format calculations, analysis component calculations (variables properties, writing basic algorithms) Good Knowledge of Labware Lot Management and Sample life cycle Configuring and customizing LabWare LIMS to meet specific laboratory needs. Integrating instruments with LabWare LIMS to ensure seamless data flow and automation. Knowledge of Crystal reports and Creation of Reports utilizing Query Tags and Access Routines Performing entry and edit of all relevant static data within the system. Acting as a liaison between internal laboratory users and the vendor to address system issues and user requirements. Developing and maintaining custom scripts and automation scripts to implement / enhance system functionality. Working with Agile teams to implement new features and improvements. Troubleshooting and resolving system issues to ensure smooth operation. Collaborating with cross-functional teams to integrate LabWare with other systems and workflows. Ensuring compliance with industry standards and regulatory requirements in all system implementations. Supporting data migration and integration efforts to ensure data integrity and consistency. Monitoring system performance and optimizing configurations to improve efficiency and reliability. The ideal candidate for this role should have strong technical skills in LabWare LIMS, experience with scripting and automation, proficiency in using Crystal Reports, and excellent problem-solving and communication skills. Show more Show less
Posted 2 months ago
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Accenture
39817 Jobs | Dublin
Wipro
19388 Jobs | Bengaluru
Accenture in India
15459 Jobs | Dublin 2
EY
14907 Jobs | London
Uplers
11185 Jobs | Ahmedabad
Amazon
10459 Jobs | Seattle,WA
IBM
9256 Jobs | Armonk
Oracle
9226 Jobs | Redwood City
Accenture services Pvt Ltd
7971 Jobs |
Capgemini
7704 Jobs | Paris,France