356 Method Validation Jobs - Page 9

Description: The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the labs continuous development through training and adherence to SOP Essential Functions: Candidate should have worked at least 3- 5 years in injectable ARD. Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc. Prepare method development report along with tentative analytical method. Attain method transfer activity. Method validation like Dissolution, Assay, Related compound and Residual solvents etc. Preparation TT report To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory. Preparation of study protocols with respect to Laboratory. Development batch stability analysis as per stability protocols Responsible for COA preparation and release of development sample against TRF. Additional Responsibilities Taking responsibility to give training to junior for on job training Attend technical workshop /seminar and explore new technique and technology at work place

Job Description Accountable to ensure timely initiation, handling, tracking and closure of QAMS elements like change control, deviation. LIR, CAPA, OOS, OOT and their investigations. To prepare/ review Analytical validation protocols / Study protocols and their reports/method transfer report. Batch release/stability sample/Method validation analysis. QC lab training coordinator Work Experience 7to 14 years Education Post Graduation in Life Science or Biopharmaceutics Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent

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, Job Summary Job Title Research Associate II Location Whitefield, Bangalore Shift General Essential Duties And Responsibilities Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines, Make sound technical recommendations in routine analytical activities Provide analysis/redesign of key experimental procedures, Produce scientific experimental data based on written procedures like method of analysis, protocols etc Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc Provide input to select analytical techniques and procedures to solve problems within area of responsibility, Apply technical theories and principles to projects within area of expertise, Independently analyze and propose solutions to research challenges Learn newer analytical techniques to enhance the capability and productivity, Author documents like Method of analysis/ protocols/ reports Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory, Participate and take ownership of equipment installation and qualification activities as per Baxters QMS, Document laboratory work performed per Baxters GDP, Work according to appropriate quality standards and quality principle (e-g , Data Integrity, ALCOA) Follow Baxters Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement, Qualifications Hands-on experience in chromatographic and/ or spectral techniques like LC-MS/MS, GC-MS, and/or ICP-MS/ ICP-OES, Operation of analytical tools/ instruments (weighing balances, pH meters etc ) and wet chemistry sample preparation techniques, Should have analytical problem-solving skills, high learning agility, innovative experimental attitude along with good presentation skills, Excellent written and verbal communication skills in English, Demonstrates an inclusive attitude and an ability to collaborate with team members and cross-functional team members for project deliverables, Ability to objectively assess, organize, and clearly communicate information, Ability to interpret available information and make recommendations to resolve technical challenges, Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner, Provide and accept critical feedback from others in a constructive manner, Adapt to changes and have an agile mindset, Embrace diversity and inclusion, value differences, Education And/or Experience Educational Qualification: Postgraduate/ Ph D in Pharmacy/ Chemistry or related field (M Pharm / M Sc / Ph D ) Professional Experience: 6 to 10 years of relevant experience 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,

Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-3 years of experience in Bioanalytical Lab.

Required 1-2 years' experience in Analytical Research (Quality Control) Analytical Method Validation by using HPLC Hands on experience in handling HPLC. Will Be Preferred for shift working Required Candidate profile Knowledge about GLP Should have handled instrument like HPLC, GC, UV, Potentiometer, KF, Polarimeter, Dissolution etc. Should experiencing in Analytical Method Validation. Perks and benefits Mediclaim, 28 PL, 5 Days working, Birthday Leave

QC Daily Analysis Conducted tests Assay and Dissolution KF ,PH Preparation of solutions for HPLC Analysis Documentation preparation like SOP,MOA,MSDS,STP

Description: The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the labs continuous development through training and adherence to SOP Essential Functions: Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc. Prepare method development report along with tentative analytical method. Attain method transfer activity. Method validation like Dissolution, Assay, Related compound and Residual solvents etc. Preparation TT report To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory. Preparation of study protocols with respect to Laboratory. Development batch stability analysis as per stability protocols To attain and complete self-training through QMS. Responsible for COA preparation and release of development sample against TRF. Additional Responsibilities: Raise indents, prepare Capex, and manage laboratory inventory. Attend technical workshop /seminar and explore new technique and technology at work place

Role & responsibilities Must have experience in Analytical Method Development. Must have Analytical Method Validation Handling HPLC Apply only API background candidate Preferred candidate profile Male candidate preferred

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

Job Description To have good knowledge about all microbiology testing. To initiate Change controls, deviations and CAPAs related to Microbiology. To prepare and review the Microbiology related documents SOPs /EOPs/ GTPs/STPs, Validation / Qualification / Re-qualification , QRM, URS etc. To monitor the Sample invert and online documents. To prepare and execute IQ/OQ/PQ of the new equipment installed. To prepare method validation protocol and report. To ensure online and accurate recording of all cGMP records at Microbiology section and to follow cGMP practices. To ensure the all-time readiness for Internal and External Audits. To ensure the timely completion of AMCs and PMs. Work Experience 7 to 10 years of experience. Education Post Graduation in Microbiology or Biotechnology Competencies

Role & responsibilities Implement norms for safety culture and 5S in laboratory Provide support and execute analytical method development and validation Coordinate for analytical testing and reporting Execute calibration of various analytical instruments as per schedule Adhere to ADL department policies and SOPs Comply with statutory and regulatory requirements Eligibility Individuals who have cleared 10th and 12th in first attempt (50% and above) MSc (50% and above), with no academic gap. Interested candidates can share their CV to juhi_bhavsar@atul.co.in or call on 81605 01583

Qualifications required: Bachelors /Masters (2-6 Years of experience in Bioanalytical Department only) Role and responsibility: 1. To work on the method development / validation / study sample analysis using HPLC, LC/MS/MS techniques as per principles of GLP, SOPs and approved protocols. 2. To plan and monitor the laboratory work involving the various processing techniques, analytical methods and standard operating procedures (SOPs) and complying with the principles of Good Laboratory Practices (GLP) as well as approved protocols to ensure the quality, integrity and reliability of the results. 3. To establish quality control program and safety of the staff and to establish corresponding corrective actions. 4. To review the raw data forms and chromatographic data sheets 5. To electronically transfer the data duly checked with the raw data and chromatograms to Pharmacokinetics department for PK analysis. 6. Review of Method SOPs, bio-analytical reports of Method Validation and Studies. 7. Review and/or approval of operational SOPS and Method SOPs. 8. Training of personnel. 9. Responding to queries from Sponsor and/or regulatory authorities.

Responsibilities: * Develop analytical methods for injectables using HPLC & GC. * Conduct method transfers, stability studies, & dissolution tests. * Validate methods through analysis & injection experiments. Health insurance Provident fund

Entire activity for Residue Lab operations Responsible for assignment, planning, Handling OOS Verification of Data & interpretation of Results Indents, procurement and costing Method development and validation Internal Training provider for the Team Responsible for Internal Audits Responsible for closure of customer complaints Technical support, answering Group lab queries Monitoring of Lab TAT Arrangement of chemicals, reagents, RMs, solvents and lab consumables on time Preparation of Standard Operating Procedures. Preparation of Method validation Reports Authorized to report, review and validation of results Qualifications 6-8 years experience of working in food testing laboratory. Strong knowledge of Food residue and contaminatsanalysis. Strong understanding of ISO 17025 implementation and accreditation process. Should have strong leadership skills to handle team of analysts, allotting and supervising the task to team and also monitoring and evaluating the work done Graduate B.Sc/M.Sc chemistry Should be open to work in Mobile Lab( Remote areas) Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such as Microsoft Word, Excel, Power Point, & etc.)

Maintenance and use of GC FID To test and analyze proximate parameters like UV parameters Analysis of Fatty acids Maintaining samples before and after analysis Maintaining the CRM Method verification & validation SOP preparation Interpretation of the results. 6-8 years experience of working in food testing laboratory. Proficient in analytical techniques of wet chemistry, proximate analysis, water analysis, Allergen testing, Measurement of Uncertainty calculation. Graduate Bsc/Msc in Chemistry

Maintenance and use of GC FID To test and analyze proximate parameters like UV parameters, Analysis of Fatty acids Maintaining samples before and after analysis Maintaining the CRM Method verification & validation SOP preparation Interpretation of the results. 3-4 years experience of working in food testing laboratory. Proficient in handling Proximate analysis, water analysis, general instruments analaysis, Allergen analysis Graduate in B.Sc / M.Sc Chemistry

To Prepare sample for the determination of heavy metals, micro minerals and minerals in Food and Agriculture samples as per ISO, IS and Customer specific requirements adopting test methods ISO, AOAC and IS methods using Microwave digestor. Maintenance of standard Reference Materials, Chemicals, Reagents and Glassware used in the laboratory. Responsible for all the instruments related to Metal analysis. Maintaining samples; before, during and after analysis. 3-4 years experience of working in food testing laboratory. Proficient in handling ICP-MS and method validation for heavy metals analysis Graduate B.Sc/M.Sc in Chemistry

Job Title : Microbiologist Biopesticide Production (Solid-State Fermentation) Location : Panoli, Ankleshwar, Gujarat, India Employment Type : Full-Time Position Summary We are seeking a skilled and experienced Microbiologist to join our Biopesticide Production Team. The ideal candidate should have expertise in solid-state fermentation (SSF) processes for the production of biopesticides. This role involves optimizing fermentation conditions, ensuring product quality, and scaling up production processes to meet industry standards. Key Responsibilities SSF Process Optimization : Develop and optimize solid-state fermentation processes to produce biopesticides, focusing on parameters such as substrate selection, moisture content, temperature, and aeration. Microbial Cultivation : Cultivate microorganisms on solid substrates like wheat bran, rice husk, and other agro-industrial wastes, ensuring optimal growth and sporulation. Quality Control : Monitor and maintain the quality of the biopesticide products through regular sampling and analysis, ensuring compliance with regulatory standards. Scale-Up Production : Assist in scaling up laboratory-scale SSF processes to pilot and industrial scales, ensuring consistent product quality and yield. Documentation and Reporting : Maintain detailed records of fermentation processes, experimental data, and quality control results. Prepare reports for internal and external stakeholders. Regulatory Compliance : Ensure all production processes comply with relevant regulations and standards, including those set by the Fertilizer Control Order (FCO) and the Central Insecticides Board (CIB). Team Collaboration : Work closely with cross-functional teams, including R&D, production, and quality control, to ensure seamless operations and continuous improvement. Qualifications Education : Masters degree in microbiology, Agricultural Microbiology, or a related field. Experience : 1-2 years of experience in biopesticide production, solid state production, preferably in the Agro-Biotech industry focusing on biopesticides. Technical Skills : Proficiency in solid-state fermentation techniques. Experience with microbial cultivation on solid substrates. Familiarity with quality control methods for biopesticide products. Knowledge : Understanding biopesticide production processes and regulatory requirements. Familiarity with the use of agro-industrial wastes as substrates in SSF. Soft Skills : Excellent attention to detail and organizational skills. Strong problem-solving and analytical abilities. Effective communication skills, both written and verbal. Ability to work collaboratively in a team environment. Preferred candidate profile - Local candidates pref. / shift working there. Whats app your cv -+916356907638 - do not call

Role & responsibilities 1. Understands and follows safety requirements within work area to identify and escalate potential hazards and also executes CAPA's for safety observations. 2. Adheres to equipment/ instrument safety procedures and understand associated energies to be isolated and execute LOTO. 3. Understand and follow safety requirements in handling material/glassware. 4. Demonstrates ability to perform physical test/physical parameter verification/ thermal test/ spectroscopy/ Electro-chemical techniques and required non-complex & complex tests and can demonstrate the same for auditors. 5. Understands and executes analytical solution preparation steps as explained in the record of analysis. 6. Recognizes abnormalities and reports malfunctioning of instruments and performs basic maintenance in line with requirements. 7. Plans cleaning of Analytical instruments & calibration and ensures timely completion. 8. Understands and adheres to written procedures. 9. Demonstrates ability to explain/ articulate procedures related to own work areas. 10. Recognizes failures in execution and report incidents, events. 11. To follow safety norms and adhere with company policy. 12. To follow the Quality Policy & Contamination prevention policy of the company. 13. Demonstrates high discipline & orientation to detail while inspecting each sample. 14. Demonstrates complete ownership of end-result of quality check. 15. Analyses raw material/ packaging/ final product, etc. or performs in-process checks Continuously acquires new skills to perform quality check with higher accuracy and prepare for any internal and external audits.

Hands on experience in HPLC/GC including method development, routine analysis and method validations along with good documentation practices. Responsible to perform the Analytical method validation, method verification and method transfer activities.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and finished products using GC, HPLC, and other relevant techniques. Develop and maintain SOPs for laboratory operations, sampling procedures, and testing protocols. Ensure timely reporting of test results and maintain accurate records.

Role & responsibilities Position Summary: As an Analytical Scientist at Off Targets Research, you will play a crucial role in the development and validation of analytical methods for the characterization of pharmaceutical products. You will work closely with cross-functional teams to support the research, development, and manufacturing processes by providing accurate and reliable analytical data. Key Responsibilities: Develop, validate, and optimize analytical methods for the analysis of pharmaceutical compounds using techniques such as HPLC, GC, and spectroscopy. Perform routine and non-routine analysis of raw materials, intermediates, and final products to ensure compliance with regulatory standards. Collaborate with R&D, Quality Control, and Manufacturing teams to troubleshoot and resolve analytical challenges. Prepare and review technical reports, method validation protocols, and standard operating procedures (SOPs). Maintain and calibrate analytical instruments, ensuring they are in proper working order. Interpret and present analytical data to support decision-making processes. Stay current with industry trends and advancements in analytical techniques. Preferred candidate profile Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is preferred. Proven experience in analytical method development and validation, preferably in the pharmaceutical or biotechnology industry. Proficiency in using analytical instruments such as HPLC, GC, LC-MS, and spectroscopy. Strong understanding of regulatory requirements (e.g., FDA, ICH guidelines) related to analytical methods. Excellent problem-solving skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Strong written and verbal communication skills. Perks and benefits Opportunity to work on innovative research projects that contribute to groundbreaking therapies. Collaborative and inclusive work environment that values professional growth and development. Competitive salary and benefits package. A chance to make a real impact in the field of pharmaceutical research. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

JOB DESCRIPTION (JD) Designation: Executive/Senior Executive Location: Gurugram Department Name: R&D Quality-CMC QA List of Responsibilities / Job Functions: Review of R&D documents such as stability data, Analytical reports, Method Qualification reports, Method verification reports, Method validation protocols & reports, Working Standard / Impurity Standard profile, analytical data of pilot bio batches and Method transfers protocol & report. Review of Lab event/Deviations/Change control/CAPA and associated investigation reports prior to Technology Transfer. Support and participate in f ailure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R&D sites. Visiting the AD Labs / Areas for verification of GDP & GMP compliance. Audit of Analytical Development department. Ensure the periodic activities as per the quality procedures are performed in a timely manner. Work in partnership with the site cross functions and corporate functions for Audit readiness. Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Perform other duties as assigned by Functional Head time to time. Review and approve the periodic activities as per the quality procedures. Support operations team during corporate audit/ external audits Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Review of Product development data and specification.

Max Life Insurance Company Limited is looking for Assistant Manager to join our dynamic team and embark on a rewarding career journey Ensuring company policies are followed. Optimizing profits by controlling costs. Hiring, training and developing new employees. Resolving customer issues to their overall satisfaction. Maintaining an overall management style that follows company best practices. Providing leadership and direction to all employees. Ensuring product quality and availability. Preparing and presenting employee reviews. Working closely with the store manager to lead staff. Overseeing retail inventory. Assisting customers whenever necessary. Organizing employee schedule. Ensuring that health, safety, and security rules are followed. Ensuring a consistent standard of customer service. Motivating employees and ensuring a focus on the mission. Maintaining merchandise and a visual plan. Maintaining stores to standards, including stocking and cleaning. Completing tasks assigned by the general manager accurately and efficiently. Supporting store manager as needed.