750 Method Validation Jobs - Page 18

We are seeking a highly skilled Analytical Specialist in to join our Research and Development team for Nasal and Inhalation Division for developing, validating the analytical methods and evaluation of sameness studies forNasal and Inhalation products. You are responsible to Develop, validate, and transfer analytical methods for Nasal and Inhalation products, including spray characterization techniques (SP, PG, DSD) and inhalation-specific techniques (APSD, DDU, Pump Delivery) along with assay and impurity methods . Should be well versed with the planning and conducting experiments for the PoP BE/sameness studies Perform Drug Master File/Literature review, procure relevant materials, and stay...

Qualification Required And Experience Qualification - MSC (Microbiology & Biotechnology) Exp - 3 to 5 Years Primary Responsibilities P lan for sampling & testing of raw materials, finished products, in-process samples, swabs, air and water, stability samples as per the given QC plans and customer specifications for microbiological testing and monitoring Sampling and Environmental monitoring Analysis and reporting (including SAP entry and COA) Trending, Investigation and CAPA for microbiological failures Surveillance for microbiology compliance Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation) GLP and documentation, la...

The ideal candidate for this position will have a mission to make good health more affordable and accessible, helping millions around the world enjoy healthier lives. Working with the leading manufacturer of generic medicines, you will be a part of a team that produces products listed on the World Health Organizations Essential Medicines List. With at least 200 million people worldwide taking our medicines daily, we are continuously striving to make a positive impact and are looking for individuals to join us in this mission. Your responsibilities will include conducting Microbiological testing on various products, such as in-process, finished products, pre-formulation study samples, and sta...

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Dedicated Centre Job Description Designation: Research Associate (9-I) or Senior Research Associate (9-II) Job Location: Bangalore Department: BBRC PD ARD GMP About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngenes clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by t...

You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cG...

Job Overview: As a Microbiologist at our organization, you will be responsible for conducting research, experiments, and analysis within the fields of microbiology, water technology, and environmental science. Your role will involve collaborating on R&D projects, devising innovative solutions, analyzing data, and working closely with internal teams and external partners. It is essential to ensure compliance with scientific standards while contributing to the advancement of the organization's research objectives. Job Description: In this role, you will be expected to: - Execute scientific research and experiments in the microbiology field. - Develop new processes and technologies related to w...

Key Responsibilities: Conduct comprehensive Extractables and Leachables (E&L) analysis using Liquid Chromatography-Mass Spectrometry (LC-MS) for pharmaceutical packaging and drug delivery systems. Develop, optimize, and validate LC-MS methods for the detection and quantification of E&L compounds. Analyze, interpret, and report LC-MS data to assess potential risks associated with material impurities. Prepare and review Standard Operating Procedures (SOPs), study protocols, validation reports, and analytical reports for E&L studies. Ensure compliance with regulatory guidelines (USP, ICH, FDA, ISO) and Good Laboratory Practices (GLP). Maintain, troubleshoot, and calibrate LC-MS equipment, ensur...

Department: ADL Experience: 5+ Years Qualification: M.Sc. (Analytical Chemistry) Location: Vadodara Job Description: We are looking for an experienced Executive in the Analytical Development Laboratory (ADL) to support R&D activities. The role involves method development, validation, analytical testing, and ensuring regulatory compliance of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for pharmaceutical substances and products. Conduct analytical testing using HPLC, GC, UV, Mass Spectrometry, etc . Troubleshoot analytical issues and ensure data accuracy and reliability. Adhere to quality control protocols and support audits (Customer/Regulatory). Mai...

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

Vipul Organics Limited (VOL) is a leading manufacturer of specialty chemicals and colorants, committed to innovation, quality, and environmental safety. With a strong legacy and global presence, we are now looking to strengthen our team with a dedicated Instrumentation Chemist at our Palghar unit. Key Responsibilities: Conduct precise chemical analysis using Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) . Ensure regular calibration, maintenance, and troubleshooting of GC and HPLC instruments. Record, analyze, and report test results in a timely and accurate manner. Maintain laboratory standards as per safety, regulatory, and quality protocols. Support the QC and R...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 02-08-2025. Requirement for Executive - FAR&D - Formulation Analytical Research & Development(FAR&D) Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting. Write cGMP Quality documents including Standard Operating Procedures, laboratory equipment procedures and investigational protocols. Excellent, enthusiastic, clear communication skills, both written and verbal, with a diverse audience are critical to the success of this position. Proven ability to...

As a part of this role, you will be responsible for sample preparation, daily calibration, and the maintenance of equipment, including keeping a detailed log of all activities. You will also be involved in method development, method validation, and conducting sample analysis in accordance with ICH M10 guidelines. Operating, maintaining, and calibrating LCMS equipment will be a crucial part of your responsibilities. In addition, you will be required to adhere to documentation procedures as outlined in Bio analytical SOPs and ICH M10 guidelines. This will involve thorough record-keeping and ensuring all documentation is accurate and up to date. Furthermore, you will be expected to review data ...

As the Quality Control Manager for injectable products, your primary responsibility is to ensure the adherence to quality control procedures in compliance with cGMP and regulatory standards such as FDA and EMA. You will oversee the testing and release of raw materials, in-process materials, and finished products, ensuring the proper documentation and traceability of quality control processes. Leading and managing the quality control team is a key aspect of your role, where you will provide mentorship, training, and motivation to ensure the team's effectiveness. Daily coordination of activities, task assignments, and setting priorities to meet production schedules are essential tasks. Regular...

Division Department Sub Department 1 Job Purpose Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements Key Accountabilities (1/6) Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission Conduct extensive literature search Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTIs on different a...

Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of...

Job Purpose and Impact The Assistant Manager - QC will provide expertise with all daily operations in quality control laboratories. In this role, you will support the buildup and maintenance of the rapid technology platform by providing reliable accurate analytical figures as well as perform validation and troubleshooting of new analytical methods to ensure they meet the requirements and deadlines. Key Accountabilities Provide analytical support to Rapid Technology Application platform by releasing precise and accurate results and ensure scope of testing parameter is sufficient to build MPA module. Provide ongoing technical support to stakeholders, investigate quality problems and deliver im...

Role Name In Community Title Senior Executive Department Sales Hiring Manager Deepak Subramanian Brief Role Description Narayana One Health is in the process of setting up a strategic team tasked with bringing health and insurance closer to patients. The initiative involves setting up primary and secondary care services that are easily accessible to patients and are supported by hyper-responsive processes built to keep patient needs and satisfaction at the center of focus. The initiative aims to bridge the gap between Narayana One Health’s in-hospital offering and patient’s everyday healthcare needs and provide patients access to a continuum of care tailored to their specific healthcare need...

Exp. in ARD/AMD of minimum -15 to 20 years Lead the development and validation of analytical methods Prepare and review technical documentation Drive analytical strategy in global or cross-functional project teams

As an On-site Application Chemist at Toshvin Analytical, you will play a crucial role in providing post-sale customer support on GCMS-MS applications. Your primary responsibility will involve visiting customer sites on a daily basis or being stationed at one customer location for a period of 6 to 12 months anywhere in India. In this role, you will support customers in method development, optimization, and validation activities related to their sample matrices. Your expertise in troubleshooting customer application issues and demonstrating advanced software capabilities will be essential. You will be expected to collaborate with the local application lab principals to address any unresolved c...

You have proven experience working in GMP/GLP and scientific environments. You possess basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, as well as peptide characterization. Your expertise lies in at least one of these subjects. Additionally, you have experience in related compound method development and method validation for Peptide drug products using LC-UV and Amino acid analyzer. Hands-on experience with SEC-UV SEC-MALS, SV-AUC, CE, and data interpretation is also one of your strengths in at least one of the techniques and data interpretation. You are skilled in the preparation and review of method development and method validation reports. Knowledge of ICH ...

Experince in HPLC & GC will be preffered Quality Control Inspection Sampling, inspection and testing of material (Analysis of material) Analytical method validation Conduct test such as Tests: GC, HPLC QC Documentation Male Candidates can apply

As a part of this role, you will be responsible for method development, method validation, and routine analysis in Orals and Non-orals Formulations. Your area of experience will include conducting the Microbial Enumeration Test, Test for specified Micro-organisms, Bio-burden Test, Antimicrobial Effectiveness Test, Sterility Test, Bacterial Endotoxin Test, Microbiological Assay, Microbial Culture propagation, maintenance, and enumeration, Growth Promotion Test, as well as Environment monitoring. In addition to the above, you will also be involved in the preparation of SOP's/STP's/Documentation, calibration of laboratory equipment/Instrument, ensuring work is conducted as per cGMP/GLP Complian...

As a valued member of our team, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your dedication to quality, coupled with our customer-oriented culture, rooted in science and compliance, will directly impact patient care. You will contribute to upholding a quality culture that evolves to meet patient needs, guaranteeing that our products meet the highest safety and efficacy standards. In this role, your responsibilities will include creating, reviewing, and approving test method transfer and validation protocols, reports, and equipment qualification records. You will maintain compliance with Good Manufacturing Practices in Quality Control and ...

You should be fluent in Application Development and have experience in developing applications for compound and biomolecule analysis. Your expertise in Mass Spectrometry will be crucial, as you will be skilled in using mass spectrometry for detection and analysis. Additionally, you should be well-versed in instrument handling and operation, understanding mass spectrometry instrumentation and its operational workflows. Proficiency in sample pre-processing techniques is required for accurate analysis, along with a strong ability in quantification and spectral data interpretation. You should also be skilled in method troubleshooting and validation, capable of identifying issues and ensuring met...

Key Accountabilities Accountability Cluster Major Activities / Tasks Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform part method validation, forced degradation studies, excipient compatibility studies, reverse engineering, add-mixture studies, in-use studies, hold-time study and analysis of routine & stability studies Conduct cleaning validation studies Perform analysis of API, excipients and secondary material (packaging material, ink, adhesive etc.) Develop cost effective & time saving analytical method for new or existing product Evaluate the pharmacopei...