10 Cglp Jobs

Research Scientist driving innovation in organic synthesis and chromatography through experiments, data analysis, and method development, ensuring compliance and commercial viability

The Chemist GC Analysis is responsible for performing GC analysis and documenting the same in compliance with cGMP, cGLP, EHS requirements, and defined operating procedures. You will be required to properly take over shift operations as per defined procedures as a reliever. In terms of GC Systems & Analysis, you will need to go through requisite procedures, plan and prioritize activities based on the work plan received from the supervisor. It is essential to ensure Cylinder status and GC column fixation and stabilization before starting the analysis. Additionally, you will be responsible for the preparation of system suitability solutions, standard solutions, and test solutions as defined in the procedures. Calibration of GC Equipment, evaluation of system suitability, and submission of chromatographs for review are also part of your responsibilities. You must adhere 100% to cGMP and cGLP practices in line with 21 CFR Part 11 and EHS requirements applicable to the QC laboratory. Timely reporting of abnormalities/deviations to the immediate supervisor/appropriate authorities is crucial. Regarding GC Documentation, you are required to record raw data related to system suitability solutions, standard solutions, test solutions, analytical and calibration results. Live recording of each activity, including instrument logbook, column usage log, working standard/reference standard/impurities reconciliation, is essential. Handing over completed documents to the reviewer/ongoing documents to the reliever is also part of your duties. In terms of GC Maintenance, troubleshooting day-to-day issues with respect to instruments with the support of an in-house service engineer is important. Successful completion of assigned trainings and application of the same at the workplace is also required. The minimum educational requirement for this role is a B.Sc. in Chemistry, while a preferred qualification is an M.Sc. in Chemistry. A minimum of 2 years of hands-on experience on Software and Instruments (Make n Model) is required, with a preference for 4 years of experience. The candidate should be aware of quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies. Competency requirements for this role include functional knowledge on Software and Instruments, analytical thinking, quality focus, and trouble-shooting skills. Behavioral competencies required are attention to detail, proactive attitude, and problem-solving skills.,

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. This position provides support to the Analytical development laboratory in technical and operational activities such as hands-on support for Physico-chemical analysis, Instrumental analysis , and material characterization or testing for product development. The successful candidate will need to possess solid hands-on technical abilities, excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. The incumbent will perform other duties as assigned. . Define, organize, plan and execute analytical activities and materials characterization of pharmaceutical injectables in compliance with current international/regional/national regulations with the support of senior colleagues and team member s. . Execute experiments towards method development, failure analysis , and root cause analysis in new product development and sustaining product projects within specified timelines, under supervision. . Work with and interpret data of advanced instrumentation techniques, hyphenated techniques , and other analytical techniques. . Execution of work as per standard guidelines like cGLP, GDP, cGMP, Data Integrity, ALCOA, and as per Baxter's defined systems, whenever applicable. . Investigate and provide technical insights for observed adverse physicochemical issues during product devel opment, scale-up, or post-marketing phases. Engage in science-based troubleshooting of the issues. . Provide proposals for product development-related innovations, analytical method innovations, and product/process improvement initiatives in collaboration with senior scientists . Ensure good internal and cross-functional communication and regular status update of activities. . Preparation of scientific product development reports, proposals, and presentations . Work collaboratively with the multi-functional and international project team in activities such as sample preparation for analysis, and operation of analytical instruments as per project requirements. . Provide support as needed in calibration and maintenance of equipment in the laboratory. . Follow Baxter's Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day -to-day activities, to ensure proactive compliance and continuous improvement Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

You will be responsible for vaccine manufacturing activities related to cell culture, including cell revival, subculture, and cell counting of MRC-5 cells. Your role will involve the preparation of Master Cell Banks (MCB) and Working Cell Banks (WCB). You should have experience in handling Roller bottles, Cell stacks, and Tissue Culture Flasks (TCFs). Additionally, you will be required to prepare media and in-process buffers in media mixing vessels. Moreover, your duties will include experience in virus infection and virus harvesting procedures. You should be familiar with working on Chicken embryo fibroblast cells, involving tasks such as pooling embryos and seeding Roller bottles. In the Quality Control department, you will be expected to perform various biochemical techniques, chromatography techniques, electrophoresis techniques, and immunoassay techniques. Your expertise should also cover cell culture techniques and molecular techniques. Furthermore, you will be involved in activities such as Analytical Method Validation (AMV), Analytical Method Development and Transfer, Quality Control (QC) procedures, and ensuring compliance with cGMP, cGLP, and Quality Management System (QMS) standards.,

You will be responsible for Vaccine Manufacturing (Cell Culture), including tasks such as cell revival, subculture, and cell counting of MRC-5 cells. You will also be involved in the preparation of MCB/WCB and handling Roller bottles, Cell stacks, and TCFs. Experience in virus infection, virus harvesting procedures, and working with Chicken embryo fibroblast cells will be required. In the Quality Control department, you will be expected to perform various biochemical techniques, chromatography techniques, electrophoresis techniques, and immunoassay techniques. Your responsibilities will also include cell culture techniques, molecular techniques, analytical method validation (AMV), and analytical method development and transfer quality control (QC). Knowledge of cGMP, cGLP, and QMS will be essential for this role.,

As a Senior Chemist at Scimplify, located in Kurkumbh, Pune, you will be responsible for various tasks related to sampling and analysis of raw materials, packing materials, and finished goods. You will be required to conduct analysis of finished products, in-process samples, stability samples, raw materials, and packing materials. Your role will also include maintaining and calibrating various lab instruments such as HPLC, Gas Chromatography, Karl-Fischer Titrator, Melting-Boiling Point Apparatus, Refractive Index, Moisture Analyzer, pH meter, and Weighing Balance. It is essential to work in compliance with approved methods, SOPs, cGMP, and CGLP standards. Additionally, you will be responsible for proper documentation of laboratory data and generating complete testing reports for in-process samples, finished products, and stability samples. You will also be involved in instrument handling, specifically with instruments like HPLC-Shimadzu-LabSolution, Gas Chromatography-Young Lin 6500-YL Clarity, Karl-Fisher Titrator-Spectra lab, Melting Boiling Point Apparatus-Spectralab, Moisture Analyzer-Mettler Toledo, Refractometer-ABBE, Way2s, Weighing Balance-Mettler Toledo, and pH Meter-Spectralab. As a Senior Chemist, you will play a crucial role in ensuring the accuracy and reliability of the analytical results while adhering to the quality standards set by the organization. Your contribution will be vital in maintaining the high-quality standards of the products manufactured by Scimplify.,

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 3 to 6 years of experience in GMP regulated pharmaceutical industry.

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Job Summary Job Title Engineer IILab, Sterility Assurance & Microbial Sciences Location Whitefield, Bangalore Shift General This position will report to Sterility Assurance & Microbial Sciences Lab Manager and is primarily responsible for laboratory contract support This role will be responsible for the overall operation, maintenance and execution of various sterilization cycles in steam sterilizer The candidate should learn the technical aspects of sterilizer and should be able to troubleshoot routine challenges related to sterilizer by coordinating with vendors The candidate should have a strong understanding of the scientific aspects related to Microbiology and Sterility Assurance, Job Responsibilities Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)Microbiology & Quality Assurance/Control Should have a good knowledge of Regulations and GMP working environment Exposure to multiple products life cycle desirable, Contribute to technical feasibility analysis of complex research and design concepts including a lot of microbiology inputs for Sterility Assurance and related controls for the products, Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & related to Sterility Assurance, Design, development & Technical Understanding of Microbial Method Validation & Sterilization Engineering principles for devices/ Solutions, Support Lab Manager by assuring contract laboratories documentation and internal lab documentation are audit ready and team can effectively respond to auditor inquiries, Work with Quality team to ensure adequate documentation, input into computer systems, and being the point person for addressing quality issues, Operation of steam sterilizer as per set procedure for various Sterility Assurance studies (Class-C & B studies), Prioritization of sterilizer cycles as per project need and urgency ensuring timely completion of project deliverables, To document all the sterilization study records manually or by using ELN templates, To learn and develop expertise in execution of different CCI methods (Air Under Water & Gurley), Responsible for calibration and maintenance of all laboratory equipment, Responsible for maintaining optimum inventory of lab consumables, Responsible for maintaining anytime audit readiness of Sterilization lab, Design and draft various study protocols as per project need, Equipment procurement and assure necessary validations and documentation, Support Lab Manager to maintain lab operations, Provide regular/timely updates to Sterility Assurance Management, Assure all work complies with Vantives QMS and cGDP/cGMP/cGLP practices, Perform standard Sterility Assurance assignments for application, validity and conformance to specifications, Utilize analytical process tools to solve complex process problems (e-g , FMEA, Risk Analysis, Process Modeling, Design of Experiments) Lead small project teams as needed to accomplish project objectives, Study and recommend techniques to improve existing products/processes and process controls, Provide sterilization support for Renal R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP), Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction, Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks, Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles, Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities, Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise, Ability to convince management on courses of action with minimal assistance using both written and verbal methods, Knowledge around microbiological aspects of biological indicators, Adventitious Agents and related microbiological concepts, Qualifications Masters degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 6 years or BS with minimum 8 yearsexperience in sterilization validation or equivalent, Prefer experience with Sterilization, Global sterilization regulations & TQM methods (e-g "six sigma") Display a solid technical understanding of Microbiological principles and qualification practices & application of these principles on individual/small projects, Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies, Strong Microbiology background and experience, Demonstrated ability to utilize resources available to ensure compliant and required documentation for contract testing laboratories and the internal R&D microbiology department, Experience managing multiple simultaneous projects and work activities, In-depth knowledge of cGDP/cGMP/cGLP practices and compliant documentation, Effectively operates in, and capable of facilitating, cross-functional teams, Knowledge of Terminal sterilization and/or pharmaceutical industry, Skills Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones, Proficient with Sterilization principles and related testing for Biological indicators etc Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators, Highly adept at grasping and solving complex problems using root-cause analysis techniques, Ability to objectively identify technical solutions and make sound decisions Project management experience for Quality & value improvement projects Self-driven, resourceful, and able to work on multiple projects and priorities, Strong organization, attention to detail, and documentation skills, Strong acquaintance with technology, QMS tools and collaboration tools over the web: e-g Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Designation :QC Officer - Microbiology / QC Officer Chemical Reports to : Head Location : Precise Analytics Laboratory - Thane Education - MSC Microbiology Exp. : (MSC Microbiology) -2-5 years experience in Pharmaceutical Microbiological testing Industry : Only pharma company Open position : 2 Job Description 1. Conduct microbiological analysis of Samples- MLT, Microbial Assays 2. To maintain all records as per cGLP and ISO 17025. 3. To monitor the quality of air & water. 4. Perform periodic calibration of Instruments/Equipments in Microbiology. 5. To Maintain the Microbial cultures. 6. Perform Swab Test MSC Chemistry/B. Pharm/M. Pharm) -2-3 years experience in Pharmaceutical Chemical Testing/Instrumentation Job Description. Conduct Chemical analysis of Pharmaceutical Samples Perform analysis of samples as per MOA on various instruments such as HPLC, AAS, UV Spectrophotometer To perform Validation of analytical methods To maintain all records as per cGLP and ISO 17025. Perform periodic calibration of Instruments/Equipments in Lab Preparation and Maintenance of standards