869 Lims Jobs - Page 24

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

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

Role Description Job Title: Dev III – LIMS Associate Engineer Experience Required: 3 to 5 years Qualification: Bachelor's or Postgraduate degree (BSc, BPharm, BCA, MCA, MSc, or equivalent) Location: [Add location if applicable] Job Summary We are seeking a skilled and proactive LIMS Associate Engineer with 2–5 years of experience, preferably with a strong background in Thermo Fisher’s SampleManager LIMS . The ideal candidate should have solid technical skills and hands-on experience in LIMS development, configuration, and implementation. Prior exposure to pharmaceutical laboratory processes and instrument interfacing is essential. Key Responsibilities Develop and configure SampleManager LIMS modules, including: Sample workflows Stock and instrument modules Instrument interfacing using Integration Manager Report Designer, Forms Designer, Label Designer Sample Scheduler, Batch and Lot Management Plate Handling, Stability, SQC, SM-IDI, PIMS, and Dashboards Participate in at least one or two LIMS implementation or development projects. Handle instrument interfaces, calibration, and maintenance requirements. Write and optimize SQL queries for database-related tasks. Develop and design reports, forms, and custom interfaces. Conduct thorough testing, documentation, and validation of developed solutions. Collaborate closely with QA, IT, and lab personnel to gather requirements and ensure solution alignment. Understand and follow ITIL-based support processes. Take ownership of technical challenges and resolve issues proactively. Required Skills & Experience Strong working knowledge of SampleManager LIMS and its core modules. Experience with instrument interfacing and lab equipment calibration/maintenance. Proficiency in SQL and experience working with databases. Hands-on experience in LIMS configuration and development. Familiarity with pharmaceutical lab practices and regulatory compliance. Good understanding of report and form design in LIMS. Exposure to ITIL processes and support lifecycle management. Strong documentation, testing, and validation practice adherence. Ability to work independently and take on challenges with a solution-oriented mindset. Preferred Qualifications Certification or formal training in LIMS platforms. Prior experience with stability studies, batch and lot management. Exposure to integration tools or scripting for instrument interfacing. Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less

Our SAP service line is currently looking for an industry-leading SAP PP QM Principal Consultant/ Solution Architect SS Please go through below JD and if have the required please share your updated resume to discuss further to me at [HIDDEN TEXT] Required Skills - SAP PP QM, S4 HANA, implementation Location Hyderabad, Bangalore, Pune. Work model - Hybrid Job Description Proven experience in sap manufacturing (PP/QM) and industry experience. 15+ 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.

Position Title: Executive – Quality Control Qualification And Experience M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job Overview Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India Show more Show less

Hello Everyone We are hiring for LIMS Developer Experience :8+ years Location : Remote Notice period : Immediate Skill : Core Java SQL J2EE, , JavaScript, JSP, and DHTML/Web Page development. JD : Strong skills in Core Java, J2EE, , JavaScript, JSP, and DHTML/Web Page development. Experience in Labvantage LIMS development Strong relational database knowledge and experience using either Oracle and/or SQL Server. If any one interested please share your updated cv to below mail id chandra.nama@appitsoftware.com Show more Show less

Job Title: Environmental PCR Laboratory Manager 📍 Location: Delhi Airport 🔍 Job Purpose: To manage and lead a PCR (Polymerase Chain Reaction) laboratory focused on wastewater testing at the airport. The role supports biosecurity measures and enhances health surveillance efforts, contributing to early detection and pandemic preparedness. Key Responsibilities: 🧬 Laboratory Management Lead and supervise a team of laboratory technicians. Oversee daily operations including scheduling, resource planning, and workflow coordination. Ensure compliance with lab safety protocols, regulatory requirements, and quality standards. 🧫 PCR Experimentation Execute and optimize PCR assays, including RNA extraction and purification. Troubleshoot technical issues and mentor lab staff in protocol adherence. Continuously improve procedures for accuracy and efficiency. ✅ Quality Control Implement robust quality control measures to ensure reliable results. Maintain accurate documentation of all quality control processes. Drive continuous improvement initiatives for lab operations. 📊 Data Analysis Ensure accurate data collection, analysis, and timely reporting. Interpret PCR results and support data presentation efforts. Maintain secure storage and management of sensitive lab data. 🔩 Equipment and Resource Management Manage and maintain PCR equipment including thermal cyclers. Coordinate repairs, calibrations, and preventive maintenance. Monitor inventory and order laboratory supplies and reagents. 👨‍🏫 Training and Development Train and mentor new and existing lab personnel. Stay current on advancements in PCR technologies and protocols. Promote a culture of continuous learning and professional development. 🎓 Qualifications & Skills: Bachelor’s or master’s degree in molecular biology, Genetics, or a related field. Proven experience in PCR lab operations and team leadership. Strong skills in PCR assay development, optimization, and troubleshooting. Proficiency with lab information management systems (LIMS) and data analysis tools. Excellent communication, organizational, and problem-solving skills. Ability to thrive in a fast-paced, high-stakes environment. Willingness to travel on short notice and take on mid-term assignments if required. Strong team orientation and customer-focused mindset. Show more Show less

This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/data needs for drug discovery research are translated into technical requirements for solution implementation. You will join a multi-functional team of scientists and software professionals enabling technology and data capabilities to evaluate drug candidates and assess their ability to affect drug targets. This includes implementing scientific software platforms like Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN), providing technical support, training, infrastructure management, and ensuring systems meet research needs. Key Responsibilities Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics and research scientists , prioritizing needs and expectations Manage a suite of custom internal platforms , COTS software , and systems integrations Lead the technology ecosystem for in vivo study data management , ensuring data analysis and data integrity Translate complex scientific and technological needs into clear, actionable development requirements Develop and maintain a product roadmap , including features, enhancements, timelines, and milestones Identify and manage risks including technological, scientific validation, and user acceptance Develop documentation, communication plans, and training for end users Ensure scientific data operations align with enterprise-wide AI/ML capabilities Ensure operational excellence, cybersecurity, and compliance Collaborate with geographically dispersed teams in the US and internationally Foster a culture of collaboration, innovation, and continuous improvement What We Expect of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Bachelor's degree with 03 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field OR Diploma with 47 years of experience in the above fields Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills with a passion for applying tech and data to drug discovery Experience writing user requirements and acceptance criteria in tools such as JIRA Experience with Benchling, Revvity, IDBS , or similar LIMS/ELN platforms Preferred Qualifications Experience with Agile methodologies (Scrum) Experience enabling data capture and analysis from lab or vivarium instruments Ability to translate technical concepts into business-friendly language Knowledge of business analysis practices , DevOps , CI/CD methodologies Experience with cloud infrastructure (e.g., AWS) and on-premise systems Experience supporting ELN/LIMS platforms in biopharma Professional Certifications (Preferred) SAFe for Teams certification Soft Skills Able to work with minimal supervision Strong analytical and gap/fit assessment skills Excellent verbal and written communication Ability to work effectively in global, virtual teams High degree of initiative and self-motivation Strong ability to manage multiple priorities Team-oriented with a focus on team success Strong presentation and public speaking skills

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting –Enterprise Risk - ER – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers 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, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality 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 Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Show more Show less

Domain SME / BA For Manufacturing For LS Job Summary: Senior Business Analyst with strong domain expertise in Life Sciences manufacturing. This hybrid role blends the analytical rigor of a BA with the strategic insight of a Subject Matter Expert (SME). You will collaborate with clients to analyze business needs, define compliant and scalable technology solutions, and bring industry best practices to digital transformation initiatives. Key Responsibilities Business Analysis & Solution Design: Elicit, analyze, and document business and functional requirements from Life Sciences manufacturing stakeholders. Translate client needs into actionable user stories, use cases, and process flows for development and solutioning teams. Collaborate with architects and delivery teams to design solutions aligned with manufacturing operations and regulatory standards. Domain Advisory Act as a trusted advisor to clients by providing insights into industry best practices across GMP, batch processing, MES, QA/QC, and shop floor integration. Guide clients in aligning technology solutions with compliance requirements (e.g., 21 CFR Part 11, GAMP 5, GMP). Contribute to validation strategies and regulatory readiness for digital systems. Client Engagement & Pre-Sales Support Participate in discovery workshops, assessments, and solution ideation sessions with prospective clients. Support proposal development with domain input, business case justifications, and solution outlines. Help craft roadmaps for digital transformation initiatives, particularly around MES, ERP, LIMS, or other manufacturing IT systems. Thought Leadership & Enablement Stay up-to-date with Life Sciences manufacturing trends and bring forward innovative ideas (e.g., digital twins, real-time release, AI in QA). Contribute to internal knowledge repositories and mentor junior BAs or team members on domain topics. Required Qualifications Bachelor degree in Life Sciences, Engineering, or a related field. 8+ years of experience as a Business Analyst, with 3+ years in the Life Sciences manufacturing domain. Deep understanding of manufacturing operations, systems (MES, ERP, LIMS), and regulatory frameworks. Strong communication and collaboration skills and the ability to work with both business and technical stakeholders. Proficiency in tools such as Visio, JIRA, Confluence, and data visualization/reporting platforms Show more Show less

Key Responsibilities: Manage user accounts, roles, and permissions within Revvity E-Notebook. Configure templates, workflows, and metadata fields to align with lab processes. Provide training and support to users; develop SOPs and user documentation. Ensure compliance with data integrity standards (e.g., ALCOA+, 21 CFR Part 11). Troubleshoot system issues and coordinate with IT and vendor support. Maintain documentation of system configurations, user logs, and change history. Support audits and inspections by providing system access logs and compliance reports. Technical Requirements: ELN Experience: Hands-on experience with Revvity E-Notebook or similar platforms (e.g., LabArchives, Benchling, IDBS). System Configuration: Ability to configure templates, workflows, and user roles. SQL & Oracle: Proficiency in writing SQL queries for data extraction, reporting, and troubleshooting; experience with Oracle databases for backend data management and integration. Data Management: Understanding of structured data entry, metadata tagging, and version control. Compliance Knowledge: Familiarity with GxP, 21 CFR Part 11, and audit trail requirements. Basic Scripting (Preferred): Exposure to scripting languages (e.g., Python, JavaScript) for automation or integration tasks. API Integration (Preferred): Understanding of REST APIs for connecting ELN with LIMS or other lab systems. IT Collaboration: Ability to work with IT teams on system upgrades, backups, and security protocols. Documentation Tools: Proficiency in Microsoft Office, SharePoint, and documentation platforms like Confluence or Notion. Soft Skills: Good communication and interpersonal skills. Ability to work independently and in cross-functional teams. Experience: 3 - 5 years of relevant industry experience. Show more Show less

Position Title: Executive – Quality Control Qualification And Experience M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job Overview Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India Show more Show less

Context Sanofi strategic direction is to standardize processes across sites, to embrace the digital transformation of its Manufacturing & Supply perimeter, looking at the opportunity to simplify its current solution landscape and leverage advanced technologies to bring business value. In that context, the MARS program aims to implement the Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). The MARS (MES Accelerated Roadmap @ Sanofi) program will transform Sanofi plants, improving compliance, cost and cycle time performance. Over the last 3 years, Sanofi has deployed 30 Production sites across 4 GBUs (multiple and different pharmaceutical processes, 18 Weighing & Dispensing & 12 full MES), and a second wave, should start in the coming years (> 50 production sites, pending business case confirmation). This represents a strategic opportunity for an Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value for Manufacturing & Supply and deliver best-in-class solutions to our industrial sites, with a high focus on electronic batch record management (content, execution) & review by exception process; Deliver innovative "state of the art" tools enabling performance for manufacturing processes across the industrial affair sites; Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently About the job The Digital MES Deployment & Integration Expert ensures the optimal performance of MES systems and Platforms by delivering solutions tailored to business needs. This role plays a central part in the deployment and evolution of Sanofi’s MES Core Model across industrial sites. Main responsibilities: End to end responsibility to install, configure, and update Industrial sites MES Digital systems and Platforms. Provide high-level of support, coordination, and communication to Industrial sites projects, maintain documentation, and drive continuous improvement. Contribute to the evolution towards an innovative MES Standard by leveraging AI, Cloud services and DevOps tools. Optimize MES performance and monitoring through development and automation initiatives. Occasionally, it may be required to perform the installations / updates over the weekend depending on the industrial site requirements. Share knowledge and foster digital skills development within the MES domain. This cross-functional role involves close collaboration with industrial sites, digital teams, infrastructure, cybersecurity, and external partners. The expert stays up to date with internal standards, industry best practices, and emerging technologies, while also contributing to the optimization of digital maintenance processes and tools. MES Scope: MES Solutions Siemens MES Opcenter Execution Pharma Product Koerber MES PAS-X Product Technical landscape: Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# - Power-shell – VB – PL/SQL End-to-end pharmaceutical manufacturing process Production & Work Instruction Execution Traceability & Genealogy Weighing & Dispensing Integration with ERP, SCADA, LIMS, WMS, Labeling, OEE, Data Platforms Recipe & Batch Management Quality Control & Compliance (GxP) Real-time Monitoring & Performance Tracking Automation & Digital Maintenance Support About you Experience : 5+ years of experience in the Digital Manufacturing Execution System (MES) domain within the pharmaceutical industry, with a strong interest in upskilling on emerging technologies and enhancing MES technical capabilities and Industrialization, or 5+ years of experience with Cloud technologies and DevOps tools, driving automation, scalability, and system reliability/Industrialization, with a strong interest in upskilling in the functional MES domain. Soft skills : Strong focus on value delivery, with the ability to work autonomously on solution design and take ownership and leadership within the assigned scope. Proven ability to work effectively in large-scale multicultural, multilingual, and matrixed organizational environments. Solid understanding of manufacturing processes in pharmaceutical plants, with strong knowledge of GxP regulations. Agile methodology practitioner Knowledge of reporting tools (Power BI) MES Solutions Technical skills : Siemens MES Opcenter Execution Pharma MES Product Koerber MES PAS-X MES Product Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# - Power-shell – VB – PL/SQL Education : Engineering or Masters in Computer Science or related field (or equivalent experience) Languages : English Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Description: To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site Essential Functions: To be responsible for Analysis and Calibrations of Quality Control Laboratory instruments. To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions. To be responsible for Maintaining of Good Laboratory Practices in lab. To be responsible for Checking regular cleanliness of laboratory. To be responsible for Management of all types of Standards. To be responsible for Receiving and maintenance of Chromatographic columns. To be responsible for Cleaning of Instruments. To be responsible for Receiving samples and In-warding them in the respective registers/LIMS. To be responsible for Preparation and execution of Protocols. To be responsible for Maintain the contact with vendor. To be responsible for Daily temperature monitoring of QC laboratory Additional Responsibilities: To be responsible for Investigation related to LIR, deviations, OOS and OOT. To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's. To be responsible for Handling of Caliber e-LIMS Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance. Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 7 Year in QC department of sterilemanufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 yearswithin existing role.

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 KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department 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.

Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India

Purpose As a Technical Consultant (TC) working with the implementation team, you will deliver implementation and/or consulting to projects to achieve successful on-time projects with client satisfaction. As an integral part of this team, you will be primarily responsible for developing C#, PL/SQL code, and Telerik reports to support these client projects. Essential Functions Develop custom code using PL/SQL to query and execute functions within the Clinisys Laboratory Solutions (CLS) LIMS platform, typically working from details provided by team members or working directly with the clients. Configure reports using Telerik Report Writer to be generated from within the Clinisys Laboratory Solutions (CLS) LIMS platform, typically working from details provided by team members working directly with the clients. Perform all alpha testing on the work you develop to ensure it meets all specified requirements and works properly when executed from within the CLS platform. Demonstrate completed work either to internal team members or directly to the clients as needed. Develop a strong understanding of the CLS functionality and its data model. Provide guidance to internal team members as to how to best accomplish specific project goals within that platform. Provide input to process improvements by monitoring both client and departmental feedback. Maintain a high level of commitment to superior customer satisfaction through the entire duration of the customer relationship. Resolve project issues in a timely manner or determine when escalation to senior staff or management is required. Collaborate with and mentors other Technical Consultants and Professional Services Consultants to expand own and others depth & breadth of Clinisys product knowledge. Effectively organize and prioritize project tasks to ensure timely completion of projects assigned. Complete other tasks as assigned. Skills needed to be successful Ability to work independently and effectively manage project priorities from start to finish Strong understanding of client/ laboratory workflow concepts relative to software applications with strong knowledge of interfaces Strong communication and presentation skills with the ability to present to all levels of the organization Strong analytical and problem-solving skills Able to provide mentoring and consultation to improve workflow processes and procedures. Required Experience & Education Bachelor’s degree in Computer Science, Software Engineering, Data Science, Bioinformatics, Healthcare, Chemistry/Biology, Life Sciences/Pharma, Forensics/Toxicology, or related field, or equivalent relevant work experience. 3+ years’ experience working with a LIS or LIMS system 3+ years’ experience with PL/SQL query writing (Oracle DB Knowledge preferred) 3+ years’ experience with C# programing 3+ years’ experience developing LIS/LIMS reports using a common report writing tool (i.e. Crystal Reports, SSRS, etc.) Shift Timings: This is a permanent role comprising a five-day week with shifts to cover our core UK hours from Monday to Friday. For India these are UK shifts from 1:30 PM to 9:30 PM IST. Preferred Experience & Education 3+ years’ experience developing reports using Telerik report designer 3+ years’ experience with Horizon LIMS, especially as a LIMS administrator 3-5 years’ experience working in a LIMS/LIS implementation environment 3+ years’ experience with API/Interfaces (HL7) Physical Requirements Work is performed in a normal office setting with minimal exposure to health or safety hazards. Prolonged periods of sitting at a desk and working on a computer. Up to 25% travel may be required. Moderate lifting/carrying 15-44 lbs; use of fingers, walking/standing 2-6 hours Exposure to hazardous materials or various weather conditions Travel to client sites that can pose risk associated with healthcare organization May be required to follow customer location health and safety requirements

Summary Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility. Support manufacturing sites with QC and related activities. About The Role Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities. Validate spreadsheets Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs) Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc Trend and report all QMS elements as per the request Monitor, trend and report Health Safety and Environmental parameters Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Perform activities of a Quality Control expert as defined by the respective sites Support regulatory requirements – routine queries, Chromatogram requests Compile Quality performance management decks Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed Essential Requirements Pharmacy/ Science/ equivalent from a reputed institute Min 3 years of experience in Quality Control / Analytical R&D / Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices GxP knowledge, Basic IT knowledge Good communication, presentation and interpersonal skills Experience of working closely with the global stakeholders Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. 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

What’s The Role Shell's Environmental Reporting System (SERS) needs replacement to ensure regulatory compliance. The new program, "Environmental Insights," will report environmental metrics like GHG emissions, waste, water, and biodiversity. It's a top priority for Shell, receiving high-level visibility. The program aims to deliver a streamlined, integrated reporting solution, enhancing transparency and insights into environmental targets and regulatory commitments. It supports Shell's Powering Progress strategy and will implement Sphera Environmental Accounting and Compliance Assurance modules to improve reporting processes and data accuracy. As a Technical Specialist – Environment Insights is responsible for taking a lead role in coordinating and developing regulatory reports and applications for project operations, ensuring compliance with environmental regulations and legislation. Update environmental management plans, provide analytical support for GHG energy management systems, and troubleshoot issues for accurate emission reporting. Support audits, environmental monitoring programs, and provide daily technological support. Identify improvement opportunities using data analysis and best available technologies. Manage operational issues, support the net-zero emissions journey, and lead benchmarking activities. Ensure quality of operations reporting, increase collaboration, and champion continuous improvement initiatives. What You’ll Be Doing Responsible for taking a lead role in the coordination and development of regulatory reports and applications required for Project operations including regulatory requirements stipulated by the Commercial Lease, Project Certificate, water licenses and other regulatory instruments, legislation and approvals. Responsible for developing a proficient understanding of applicable environmental regulations and legislation and communicating implications on Project operations to management. Update Project Environmental Management and Monitoring Plans to reflect Projection operations and procedures. Provide analytical support in activities pertaining to GHG energy management systems (PI, EC, LIMS, EEST, CEMIS) and troubleshooting issues to ensure accurate emission measurement and reporting in SERS, Planning Systems and GCAT. Support and coordinate audits and verification of environmental data. Support the coordination of environmental monitoring programs and initiatives in tandem with site environment teams. Day to day technological support to operations (monitoring, guidance, optimization, trouble shooting, product quality assurance) Developing opportunities for improvement in key areas, including pro-active identification of abatement opportunities using Data Analysis including economic modelling, Best Available Technologies (aligned with asset improvement plans, external commitments, regulatory reporting and legal compliance). Manage and follow-up on operational issues, performance metrics, and determine root cause of the problems and implement sustainable corrective action. Support the net-zero emissions journey for the asset including bringing operational learning to different performance management and business planning processes. Support internal and external benchmarking activities (including data collection, analysis and reporting) and lead the effort to improve the existing systems and ways of working. Ensure Quality of Operations Reporting and Data Integrity. Track the quality of deliverables within the agreed cost and timeline and resolve if any quality issues / complaints raised by stakeholders in a satisfactory & timely manner Increase collaboration within TAO and with other processes Champion in Continuous Improvement (CI) implementation and ensure delivery of benefits. What You Bring Masters of Science/M.tech in Chemical Engineering/Process Engineering/ Environmental Engineering, or Bachelor’s Degree in Carbon Management. 5+ years of experience in an LNG, upstream, petrochemical or refining facility with experience in GHG management. Advanced knowledge of air quality calculation methodologies Advanced knowledge of equipment and emission sources within oil and gas Advanced knowledge of existing and emerging global air / water regulatory reporting requirements Enhanced data skills (e.g. working with large environmental data sets and calculation tracing) Business analyst skills (requirements collection/documentation, process mapping, analytical thinking, etc.) Awareness of digital system architecture planning (data flows) Serves as team resource in monitoring GHG accounting protocols, protocol changes, and interpretations of GHG accounting rules Leading and executing proper and timely preparation of emissions data to support all sustainability reporting (inclusive of CDP reporting), including preparation of accurate and efficient quarterly emissions data reports Ensuring that all emissions accounting processes are effective, efficient, and properly controlled Optimizing internal procedures that ensure alignment to external standards and guidelines Working with verification/assurance providers on annual emissions verification for reporting, Supporting external audit, verification and compliance requirements for all legal emissions accounting and reporting Identifying, obtaining, and maintaining credentials as the sustainability industry evolves and to meet asset and company needs Leading training of Energy Transition staff on process and standards to ensuring compliance on evolving standards and guidelines Driving simplification and digitization of reporting, where applicable; reducing cycle times, re-works, and manual activities, while instigating controls; and supporting business initiatives and cross-functional projects Works with project teams in developing GHG inventories and forecasts as well as techno-economic analyses of mitigation strategies for a range of local government and private sector clients. Works with project teams to develop qualitative decision support tools that evaluate climate action strategies through multiple lenses, including potential for mitigation, adaptation, resiliency, equity, and green economy benefits Ability to effectively lead a team of multi-disciplinary highly skilled staff. Goal oriented with a high degree of achievement drive and initiative and ability to get things done. High analytical ability combined with pragmatic approach to solving problems. Service oriented and customer focused. Influences policy formation on contribution of specialization to business objectives. Influences at level of division internally and influences customer/suppliers and industry at senior management level. Decisions impact work of employing organizations, achievement of organizational objectives and financial performance. Develops high-level relationships with customer’s suppliers and industry leaders. 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 organisation 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 programmes. Show more Show less

Experience in Labvantage LIMS development Strong relational database knowledge and experience using either Oracle and/or SQL Server If any one intersted please share resumes to my email id : gopala.krishna@appitsoftware.com Show more Show less

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelors degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance.

Role Description Job Title: Dev III - LIMS Associate Engineer Experience : 4 to 7 years Qualification : Any degree or PG (BSc, BPharm, BCA, MCA, MSc, etc.) Key Skills And Responsibilities LIMS Expertise: Hands-on experience with SampleManager LIMS including configuration and development. Development Knowledge: Solid background in LIMS development with at least 1 or 2 completed implementation/development projects. Workflow Configuration: Expertise in developing/configuring Sample Workflows, Stock Module, Instrument Module, Instrument Interfacing using Integration Manager, Report Designer, Forms Designer, Label Designer, Sample Scheduler, Batch Management, Lot Management, Plate Handling, Stability, SQC, SM-IDI, PIMS, and Dashboards. Pharma Laboratory Practices: Prior experience or knowledge in pharmaceutical laboratory practices and familiarity with instrument calibration/maintenance. Technical Skills: Strong technical and configuration skills, with the ability to handle challenges effectively. Database and Query Writing: Familiarity with databases and experience in writing queries for troubleshooting and configuration purposes. Report and Form Design: Experience in developing reports, form designs, and related tasks within LIMS. Validation and Testing: Knowledge of testing, documentation, and validation practices in line with industry standards. ITIL & Support Process: Understanding of ITIL and support processes to ensure smooth operation and issue resolution. Additional Skills Instrument Interface & Maintenance: Experience handling instrument interfaces and ensuring calibration and maintenance are up to industry standards. Problem-Solving: Ability to take on challenges proactively and provide solutions within timelines. Skills Sample Management,Pharmacy,Itil Process,Database Show more Show less

Description JOB DESCRIPTION To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site Essential Functions To be responsible for Analysis and Calibrations of Quality Control Laboratory instruments. To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions. To be responsible for Maintaining of Good Laboratory Practices in lab. To be responsible for Checking regular cleanliness of laboratory. To be responsible for Management of all types of Standards. To be responsible for Receiving and maintenance of Chromatographic columns. To be responsible for Cleaning of Instruments. To be responsible for Receiving samples and In-warding them in the respective registers/LIMS. To be responsible for Preparation and execution of Protocols. To be responsible for Maintain the contact with vendor. To be responsible for Daily temperature monitoring of QC laboratory Additional Responsibilities To be responsible for Investigation related to LIR, deviations, OOS and OOT. To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's. To be responsible for Handling of Caliber e-LIMS Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance. Qualifications Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 7 Year in QC department of sterilemanufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 yearswithin existing role. Show more Show less

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 KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of 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

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Quality Control Manager Date: Jun 11, 2025 Location: Panoli - Quality Control Company: Sun Pharmaceutical Industries Ltd JOB DESCRIPTION Quality Control Manager Designation: Manager 1 Location: Panoli, Gujarat Department: Quality Control Group/Area: GC section and Working standard section Work planning, distribution and monitoring of GC section and working standard section. LIMS template preview and Instrument method preparation and updation in Empower. To initiate Laboratory event/out of specification /out of trend /Deviations/change control in the Track Wise and perform investigation as per the SOP. To ensure working standard qualification activity. To ensure procurement activity and availability of Reference standards/Impurity Standard/GC standards/GC columns. To ensure cleaning of Instrument, work place and Laboratory Training given to subordinates To ensure PPEs as per work requirement and maintain safety in laboratory Other activities instructed from time to time. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less