33 Chromeleon Jobs - Page 2

Department: Analytical Development Injectables / Complex Injectables US Market Job Description: Method Development of Drug Product and Method verification of Raw Materials using HPLC, UHPLC with sound knowledge of Chromeleon & Lab solution software. To perform analysis of Drug Product and Drug Substances for various test parameters and as per the product development requirement. Compilation of analytical results and preparation Method Development Report. Literature survey to support method development of Drug product and characterization activity of Drug product. Compilation and monitoring of routine and stability analysis data. Support to formulation team to develop the drug product.

Responsibilities: * Education : B.pharm/M.pharm/M.sc * Candidate should have experience of Chromelian software / LIMS Software. Chromelian software is must. *Conduct reviews of QC procedures. * Ensure compliance & regulatory standards through QC. Annual bonus

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

Desired Candidate Profile 5-10 years of experience in LIMS development, testing, or deployment. Required Skills & Experience Development experience with Labware LIMS (Laboratory Information Management Systems) Should have Chromeleon application Support experience. Should have Labvantage LIMS experience. Should know master data configuration for various type of objects, especially test methods Should be able to configure complex calculations and set up Groovy calculations in test method.

Job description Job Title: Desktop Support Engineer | Pharma Industry | Bangalore /Hyderabad Location Company: Instrumentation and Control Solutions (ICS) Website: www.ics-india.co.in Location: Bangalore/Hyderabad Experience: 2-8 years (Pharma Industry experience mandatory) Qualification: BE/B.Tech/ Any Graduation Key Responsibilities: Maintain inventory of manufacturing automated systems, including PLCs and SCADA systems. Install and maintain computer hardware and peripherals. Install and upgrade operating systems and computer software. Troubleshoot networking and connection issues. Provide recommendations for software or hardware upgrades. Assist in 21 CFR Part 11 compliance assessments during computerized system selection. Prepare and maintain IT-related SOPs for Manufacturing Automated Systems. Participate in the qualification and validation of automated systems from an IT perspective. Prepare daily reports and manage manual backups (weekly/monthly/yearly). Manage service and incident requests via the help desk dashboard. Skills Required: Strong technical knowledge. Basic understanding of computer systems and networks. Eagerness to learn new technologies and processes. Why Join Us? Work with a reputed MNC Pharmaceutical Client. Be part of a dynamic team focused on cutting-edge technology in manufacturing automation. Enjoy a collaborative and growth-oriented work environment. Application Process: Interested candidates can share their updated resumes at hr@ics-india.co.in or contact us at 9109102346 for further details. Note: This is a full-time position requiring candidates with prior experience in the pharmaceutical industry. Connect me on LinkedIn- www.linkedin.com/in/nikita-sen-2a9565114

Job Title: IT Lab Support Engineer (Off Role) Function / Role: Information Technology / Incharge Reporting to (position): IT Manager Role & responsibilities -Laborartory Support (21CFR part11 Compliance, Computer System Validation ) - Ensuring IT Software compliance and regulatory (ISO 27001:2022 \ USFDA \ NABL \ GAMP 5 \ GLP ) - Hands on Experience over Laborartory Process, Software and Documentation (ELN / SDMS / Chromeleon / GC / UV / Shimadzu / HPLC / FTIR /PSA). - Implement and manage various IT related initiatives taken up at AIL in the areas of ITAM, IT Security, IT Networking, software implementations related to IT, IT infrastructure and devices, Video Conferencing etc. at AIL location, in line with the IT roadmap. - Manage a team of 2-3 IT Engineers locally or remotely. Should have experience in Daily/Weekly Reporting and IT support team Management skills. - PR Creation in SAP and approvals including co-ordination with purchase and finance teams - Should be able to Manage IT Budgeting activities and IT Expense tracking against approved budgets - Implement, Manage and monitor IT Projects, MoCs (Management of Change) and Business projects related to plant location. - Project tracking, IT operations management and stakeholder management - Implement effective IT security systems on servers, network, user endpoints (laptops and desktops) and documentation to ensure security of data and applications in accordance to ISO 27001:2022 controls as per central team guideline - Coordination with Central team for management of Firewalls, switches, AV etc. - Implementation of SAM(Software Asset Mgmt) and ITAM/ISMS processes and applications at plant location in line with element guideline - Ensuring software compliance for all softwares being used at AIL site/plant locations. - implement various monitoring tools related to IT infrastructure, Log monitoring, IT Network and End user computing as per central team guideline - Manage and maintain change management as per IT Guidelines - Manage contracts for Network, Bandwidth, End-user Compute and other components in infrastructure/environment - Periodic review with vendors and ensure adherance of SLAs - New technology evaluation and implementation as per need of plant location - Design, develop and impart training content for IT related systems to users/IT team. - Proactively Plan and upgrade infrastructure as per business need - Good organizational and time management skills - Excellent communication and interpersonnel skills - Analytical thinker and problem solver

Department - Quality Analyst Position : Executive / Senior Executive Experience : 3 to 6 Years Qualification : MSc/Bsc/Bpharma/Mpharma Location : Jaipur Experience in Tablet/Capsule/Liquid Oral Formulation. Immediate Joiner Preferred

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