750 Method Validation Jobs - Page 22

About Us Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs. Job Roles & Responsibilities Analytical Method Development & Validation: Develop and optimize analytical methods for pharmaceutical compounds using HPLC, GC, UV-Vis, and other analytical techniques. Perform method validation studies including accuracy, precision, linearity, specificity, and robustness testing. Transfer analytical methods between laboratories and...

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file. Responsible to follow safety precaution as per laboratory procedure. Responsible to escalate any issue / incident to reporting manager for prompt corrective action. Responsible for method development studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for method Validation studies of API, Drug Product & In process Material preferably Peptide molecules Responsible for routine and stability studies of API, Drug Product & In process Material preferably Peptide molecules Responsible...

Description: To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc.). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP,...

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Act as Senior Analyst in Bioanalytical Biosimilar Department Department : Bioanalytical- Proteins & Biosimilars Designation: Executive Location : - Ahmedabad Education : M.SC Biotechnology/ Biochemistry Experience: 4-6 yrs. CTC range : 8-10 Lac/annu...

Role & responsibilities 1. Knowledge of calibration and operation of HPLC with empower software. 2. Sound knowledge of analytical method development and Analytical method validation of OVI, purity, and assay method by HPLC as per pharma guidelines. 3. Knowledge of caliberation and operations of all equipments like balance, ph meter, in analytical opeartion. 4. good knowledge of sample preperation as per GLP. 5. Knowledge of retreival and storage working standards and columns. 6. Handling of final compilation of raw data, chromatographic data complying with GLP requirements. 7. Recording all analytical activities, approximately in respective raw data forms. 8. knowledge of preperation of gene...

HPLC Analysis Method Validations Method Developments. Calibrations. Forced Degradation Studies Required Candidate profile HPLC Analysis

Regular Batch Analysis by using LCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS

Role & responsibilities 1. Knowledge of calibration and operation of HPLC with empower software. 2. Sound knowledge of analytical method development and Analytical method validation of OVI, purity, and assay method by HPLC as per pharma guidelines. 3. Knowledge of caliberation and operations of all equipments like balance, ph meter, in analytical opeartion. 4. good knowledge of sample preperation as per GLP. 5. Knowledge of retreival and storage working standards and columns. 6. Handling of final compilation of raw data, chromatographic data complying with GLP requirements. 7. Recording all analytical activities, approximately in respective raw data forms. 8. knowledge of preperation of gene...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 05-07-2025. 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...

Sterility, bioburden, endotoxin, AET/PET testing Method validation for medical & polymer products Lab setup, media prep, equipment handling Water (WFI/CS) & environmental monitoring Data review as per cGMP & compliance norms and Maintain lab records

Dear All, We are looking for Nitrosamine exposure candidates who are having an experience of 3-5 Years into the industry. Responsibilities: Lead method development and validation for trace-level detection of nitrosamines and NDSRIs using advanced instrumentation (GC-MS/MS, LC-MS/MS). Perform root cause analysis and establish robust impurity control strategies based on analytical data and scientific rationale. Prepare and review method validation protocols, risk assessment reports, and regulatory documentation for nitrosamine-related investigations. Interpret analytical data in compliance with GLP, ICH guidelines, and regulatory agency expectations. Drive nitrosamine risk assessments for APIs...

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Department – Sales, New Generation Insulin BU Novo Nordisk India Pvt Ltd

Analytical method development of API and intermediate. Handling of HPLC, GC, Karlfisher, potentiometry titration. Preparation of specification and STP. Titration expertise. Daily work reporting, literature search and trouble shooting in QC Labs. Required Candidate profile Must worked in ADL department of API industry for at least 5 Years. Perks and benefits PF Transportation Canteen

Walk-In Drive For API Analytical Research & Development(AR&D)- MSN Laboratories, Pashamylaram, R&D center on Saturday 05-07-2024. Requirement for Executive / Senior Executive - API AR&D - API Analytical Research & Development(AR&D) HPLC,GC,GCMS,LCMS,PXRD High performance liquid chromatography (HPLC) & GC HPLC with Software lab solu. UV-VIS Spectrometer GC with Software lab solution PH-Meter Moisture Analyser Karl Fischer titrator Micro- Weighter Balance Responsible for an Analytical team involved in Method development, Method Transfer and Validation for various stages of drug development. Method Validation of analytical methods as per internal and country specific regulatory guidelines and e...

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and m...

We are looking for a skilled R & D (Analytical Development) Professional with 4 to 9 years of experience to join our team. The ideal candidate will have a strong background in analytical development and excellent problem-solving skills. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance product quality. Collaborate with cross-functional teams to design and execute experiments and tests. Analyze data and results to identify trends and areas for improvement. Design and develop new products and processes using analytical techniques. Conduct research and stay updated on industry trends and developments. Provide technical support and guidance to junior...

R & D (Analytical Development) - Agrochemical Industry-Saykha,Gujarat. Industry Engineering Engineering Design R&D Quality Qualification Key Skills Green Field Projects UPLC R & D Analytical Development Chemical Research Chemical Chemical Analyst Analytical Chemical Analytics We are looking for a skilled professional with 5 to 11 years of experience to join our team as an R & D (Analytical Development) specialist. The ideal candidate will have a strong background in analytical development and excellent problem-solving skills. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance laboratory efficiency. Collaborate with cross-functional teams to design...

R & D (Analytical Development) - Agrochemical Industry-Saykha,Gujarat. Industry Pharma R&D Biotech Qualification M.Sc Key Skills R & D Analytical Development LAB Agrochemical UPLC Green Field Projects HPLC Chemical Research We are looking for a skilled professional with 5 to 11 years of experience to join our team as an R & D (Analytical Development) specialist. The ideal candidate will have a strong background in analytical development and a passion for driving innovation. Roles and Responsibility Develop and implement new analytical methods and techniques to drive business growth. Collaborate with cross-functional teams to design and execute experiments and studies. Analyze data and result...

Department : Analytical R&D Open Positions : LCMS, HPLC, Wet Lab, Solid state characterization and DQA Work Locations : Shameerpet, Hyderabad Job Description: Need to have strong theoretical knowledge (HPLC/LCMS/WETLAB) Plan and conduct the analysis with required skills. Record the observations meticulously and update to the TL/SME. Share and discuss the observations with supervisor. Independent in maintaining the instrument and setting up the instrument for analysis. Expected to be aware of basics in analytical chemistry (basic analytical techniques Theory and application) as well as handling of laboratory equipment / instruments with basic understanding. Expected to be aware and working in...

Preparing test solutions, compounds,and reagents for conducting tests and advising and coordinating test procedures(qualitative and quantitative chemical and collect/physical analysis of raw materials. Experience in making lab SOPs and study reports 6+ yrs of Agrochemicals/chemicals in Green field/brown field Projects Exp in handling instruments like UPLC, LC-MS , GC, ICP-OES, XRD & DSC