945 Method Validation Jobs - Page 4

Roles and Responsibility Conduct experiments and tests to analyze the composition of substances. Develop and implement new methods and techniques for analyzing chemicals. Collaborate with cross-functional teams to achieve project goals. Interpret data and results from experiments and tests. Maintain accurate records of experiments and results. Stay updated with industry developments and advancements in analytical chemistry. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Responsible to prepare protocols ,reports, Sop's, review docs and analysis, methods development, verification validations for AET,MLT Sterility test& BET, follow GMP&GLP,SILUTION STUDY/microbial ingress study.

Role & responsibilitie This role is focused on performing analytical testing using instruments like High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC). To perform Validation/Verification related activities as per Validation/Verification protocol.

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company, engaged in developing high quality, affordable biosimilars to expand access to cutting-edge therapies globally. As a fully integrated pure play biosimilars organization, Biocon Biologics aspires to transform patient lives through innovative healthcare solutions. With a large portfolio of biosimilars under global clinical development and multiple commercialized products in developed markets, Biocon Biologics believes in the power of strong partnerships to co-create the future of healthcare and positively impact millions of lives. Key Responsibilities: - Adherence to cGMP, cGLP, and GDP standar...

Role & responsibilities Plan, execute, and complete the method development and method validation, execute methods for the analysis of study samples within the committed timelines. 2. Supervision of sample processing and analysis for BA/BE studies as per applicable regulatory requirements. 3. Preparation and review of bioanalytical method validation reports, method SOPs and study reports. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Review of protocols, electronic generated data, raw data forms and logbooks, to ensure validity and accuracy. 6. Ens...

Role & responsibilities Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. 2. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated. 3. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities. 4. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements. 5. Ensure compliance t...

You will be responsible for facilitating microbiological analysis and providing support in process analysis, method validation, and maintenance of analytical instrumentation in the microbiology lab at Hyatt Centric Janakpuri, New Delhi. Your role will involve conducting Hygiene Audits, maintaining HACCP/Hygiene activities, providing training, and more. Key Responsibilities: - Facilitate microbiological analysis - Support in process analysis and method validation - Maintain analytical instrumentation in the microbiology lab - Conduct Hygiene Audits - Maintain HACCP/Hygiene activities - Provide training to staff Qualifications: - Previous experience as an Assistant Manager - Hygiene in a large...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Perform method verification/validation of compendia/pharmacopeial updations, Me...

Must be good in Chemistry and Wet tests. QC different modern apparatus exposures and SAP knowledge preferred. Must understand basics of dry and Tests, QC methods and documentation, Incoming RM and finished goods Q.C. experience, COA exposures. Required Candidate profile Must be a good student of Chemistry with understanding of name Reactions, Elements detection, use of ultra modern techniques of QC Perks and benefits Mediclaim Canteen Transport learning & fast career

The successful candidate will be responsible for designing, developing, and optimizing OSD formulations, ensuring product quality, stability, and performance. Interested candidates please sent your resumes to email id: jones.naveen@insta-pill.com Food allowance Health insurance Office cab/shuttle Provident fund

Role & responsibilities : Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables) Daily calibration of pH meters, balances etc. Stability sample management (loading & withdrawal as per stability plan) Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicable Hands-on experience of analytical instrumental techniques (HPLC with chromatographic software etc.) Assisting analytical method development/validation/method transfer activities, as per need Supporting other assigned lab responsibilities for GLP compliance Location: Shamirpet Mandal, Medchal- Malkajg...

Department: R&D analytical 1. Sound Knowledge of HPLC method development, method validation for Assay and Related substance. 2. Routine Analysis of raw materials, intermediates and finished products. 3. Sound knowledge of analytical instruments like HPLC, Gas Chromatography, Infrared spectrophotometer, UV spectrophotometer, Auto titrator, Karl Fisher, Particle Size Analyzer etc. with analytical data interpretation. 4. Good hands on experience of Drug excipient compatibility study and evaluation of analytical data. 5. Sound practical knowledge of dissolution method development and method validation for different formulations and evaluation of the data. 6. Chemical / WET analysis like Titratio...

Role & responsibilities MD / MV and Study handling Perform method development and method validation using ligand binding assays, cell-based assays and LC-MS/MS based assays. Perform study sample analysis for the respective projects as delegated by the supervisor. Document and compile raw data, unforeseen event, file note and deviation. Interpret the data / result and perform troubleshooting if required. Complete MD/MV and Study efficiently as per the defined timelines. Inventory management Responsible for timely procurement of chemicals/reagents/consumables and maintaining inventory for MD/MV and study sample analysis related activities. Preparation of documents Responsible for preparation o...

Candidate should be competent to handle the assigned activity related to analytical method validation (Test Related substances, Assay, Residual solvents Force degradation), Finished API on HPLC, GC GCMS System as per standard operating procedures. Documentation practices as per GLP and GDP requirements. Candidate should have good learning ability, technical knowledge good analytical skill

Role & responsibilities Testing: Perform qualitative and quantitative analysis on raw materials, intermediates, and finished products using various techniques (e.g., HPLC, GC, UV-Vis, titrations). Documentation: Maintain accurate and detailed records of all testing performed, including test results, logs, and stability reports. Compliance: Ensure all procedures and products comply with regulatory requirements, such as cGMP, GLP, and pharmacopoeia standards. Equipment management: Calibrate, maintain, and troubleshoot laboratory equipment to ensure accuracy and reliability. Troubleshooting: Investigate quality issues or deviations and help implement corrective and preventive actions (CAPA). Co...

Job Title: Manager / Sr.Manager – API Cluster Support (QA) Business Unit: Global Quality & Compliance Job Grade G10 / G9B Location : Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Summary : The Senior M...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and complia...

Job Description The role will have the following responsibilities: Responsible for planning stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and comment...

Role & responsibilities Complete Analysis of various raw materials, In-process, Drug substance and finished Products in line with Pharmacopeia method and in-house Specification and test procedures. Change Control, Deviation, Root Cause investigation, CAPA, OOS, OOT, Incidence Calibration of Instruments HPLC , UV-Visible Spectrophotometer, pH Meter,KF Titrator, weight balance. Working standard preparation as per SOP. Ensure the timely analysis of samples GLP, GMP, GDocP (With respect to Regulatory Guidelines) Function in details of various Section of QC/QA(Eg.Raw Material, Finished Product,Stability Study etc. Data Integrity 21 CFR Part 11 Qualification, Calibration, Validation. Maintaining t...

Job title ADL executive Division phrama Function Analytical method validation Location dombivali Designation ADL executive Job Grade Reporting to (position) ADL Head Direct Reportees (Nos) Company Name Aart industries limited Key Role & Responsibilities 1)Able to performed method validation on GC HS 2)analytical method transfer 3) Able to performed method validation on GCMS 4)method development on GC 5)Handling incident and deviation 6) online review of system,log books 7)Aware of 21 CFR part 11 guidlines ICH and Anvisa Guidlines 8) GC MS and LCMS Linkages within / outside the organisation Internal External Job specification Experience min 9 years Qualification MSc CTC Range as per company b...

Capable to perform routine work on instrument's AB Sciex LC-MS/MS To monitor and give a first check for the activities completed by Analyst, Jr Analyst and Trainees Preparation and compilation of the Method Development Report, Method Validation protocol and Standard Testing Procedure and reports of respective validation and projects 4) Capable to perform routine activity in Bioanalytical Lab Perform Method development, Method validation and Subject sample analysis as per GDP and in house SOPs Preparation of Stock solution, Spiking solution and Biological Samples Knowledge of Method Validation and subject sample analysis of regulatory norms Compilation of Raw data for Method validation and Su...

Roles and Responsibility Conduct quality control tests on chemical products to ensure they meet specifications. Develop and implement quality control procedures to improve product quality. Collaborate with cross-functional teams to resolve quality-related issues. Analyze data to identify trends and areas for improvement in quality control processes. Implement corrective actions to address quality concerns. Maintain accurate records of quality control activities and results. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer v...

Required Skills & Competencies Strong knowledge of GMP, GLP, OOS/OOT guidelines. Hands-on experience with HPLC/GC/UV instruments.

We are looking for a highly motivated and experienced Research Associate II to join our team at Jubilant Biosys Limited. The ideal candidate will have a strong background in research and development, with excellent analytical and problem-solving skills. Roles and Responsibility Conduct experiments and collect data to support research projects. Analyze and interpret complex data sets to draw meaningful conclusions. Develop and implement new methods and techniques to enhance research efficiency. Collaborate with cross-functional teams to achieve project goals. Design and execute experiments to test hypotheses and validate results. Maintain accurate records of experiments, results, and procedur...

Role & responsibilities To Operate, loading samples, create, quantify and save the batches as per LCMS/MS SOP. To complete necessary documentation for bio-analysis such as raw data forms and logbook entries. To ensure that Bioanalytical method development and validation activity is progressing smoothly. To ensure that all the equipment and instruments in bioanalytical lab are appropriately qualified, calibrated and validated in line with SOP. To ensure that employees in the department are trained and up to date on all aspects related to bioanalytical systems and procedures and their record are maintained up to date. Ensure that records and data of bioanalytical equipment, processes and syste...