750 Method Validation Jobs - Page 20

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...

SENIOR QUALITY CONTROL ANALYST Job Objective: The Quality Control (QC) Analyst specializing in Method Validation and Method Development is responsible for developing, validating, and transferring analytical methods for pharmaceutical raw materials, intermediates, and finished products. The role ensures compliance with regulatory requirements and contributes to continuous improvements in analytical methodologies. Qualifications: Bachelors/Masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related field. Experience: More than 8 years of experience in method validation, method transfer, and regulatory compliance within a pharmaceutical QC or analytical development en...

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Leadership role to manage team size of 10+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Managing multiple instruments (LC-MSMS, GC-MSMS, ICP-MS, IC etc.) Method development experience in LC-MS...

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Medicinal chemistry; Research and development; Literature search; Scifinder / Reaxys; Design and synthesis; combiflash/Biotage; C-C coupling etc Qualifications MSC - Organic Chemistry.

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Planning/performing and reporting of acute toxicology studies Assist in preparation of SOP"™s, Protocols and Reports Participate in GLP / AAALAC related activities Literature search Maintenance of animal house and relevant documents as per GLP and AAALAC norms. To Assist and work along with SD and TC in Plann...

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. The Project Manager Assistant (PMA) position is an administrative role working directly with a group of Project Managers, focusing on a specific area of the business. This role requires ...

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

End-to-end formulation and development of injectable dosage forms (Liquid, Lyophilized, Emulsion, etc.) Handling of scale-up, exhibit batches, and tech transfer Cross-functional coordination with ADL, RA, QA, and Manufacturing

Planning and executing assay-runs for cell based assays and ELISA as part of Method Development and Method Qualification studies Analysis of the data using parallel line analysis and equivalence testing Writing protocols and reports for Method development and Method qualification studies Maintenance of the cell lines, preparation of cell banks Review of raw data and data recording sheets and to ensure good documentation practices. Planning of day-to-day activities independently. Trouble shooting of the issues (if any) aroused during execution of assay-run. Involving in documents preparation for SOP, STP, MOA.

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical a...

Development and validation of analytical methods for injectable dosage forms Stability study execution and data interpretation Support for formulation development and regulatory submissions (US/EU) Instrument handling: HPLC, GC, UV, KF, etc. Preparation of method validation reports, protocols, and SOPs

1. Receipt, storage and usage of medias, Microbial cultures, materials and documentation 2. Perform viable / non-viable monitoring activities, media plates observations and documentation in testing facilities. 3. Environmental monitoring, sampling, receipt, testing and documentation of all Microbiology samples. 4. Perform cleaning, fumigation and other activities in Microbiology laboratory. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Preparation of dilute disinfectants, reagents solutions / indicator solutions. 7. Responsible for compliance to cGLP. 8. Operation and usage of instruments. 9. Execution of method validations / method verification samples. 10. Rece...

1. Receipt, storage and usage of medias, Microbial cultures, materials and documentation 2. Perform viable / non-viable monitoring activities, media plates observations and documentation in testing facilities. 3. Environmental monitoring, sampling, receipt, testing and documentation of all Microbiology samples. 4. Perform cleaning, fumigation and other activities in Microbiology laboratory. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Preparation of dilute disinfectants, reagents solutions / indicator solutions. 7. Responsible for compliance to cGLP. 8. Operation and usage of instruments. 9. Execution of method validations / method verification samples. 10. Rece...

Eligibility : M.Sc / M.tech (Life Sciences / Biotechnology) Technical Skills : Various Extraction Techniques Purification techniques Phytochemical Activity (Qualitative quantitative) HPLC CG AAS FTIR UV-Vis Spectrophotometer General Skills : Complete knowledge of MS Office Standardisation of SOP Sample flow management English (Reading and Writing) Candidate must have a personal Laptop

1) Experience in preparing and reviewing of Method Development Report. 2) Knowledge of ICH Guidelines. 3) Strategic planning and performing Validation studies, Solubility Studies, Impurity and Standard Qualification. 4) Exposure of working on HPLC, LCMS, GC, UV and other equipment. 5) Ability to perform an analysis of related substances, assays and purity by using HPLC, IC. 6) Ability to perform analysis of residual solvents by using gas Chromatography. 7) Preparation and Review of development and validation/ method transfers/ protocols and reports based on R&D qualifications or monographs. 8) Ability to work in a team and contribute towards collective goals.

Food Tech -calibration ,maintenance and inter of LC-MS,GC-MS method validations and method verification for food and water samples, testing peptides, residue, antibiotics, water samples and water samples using GC-MSMS &LC-MSMS

Develop analytical methods for biochemistry samples using GC-MS, LC-MS, and other relevant techniques. method validation, optimization, and transfer to ensure accuracy and reliability of results. data analysis, and reporting in accordance .

The job is based in Hyderabad and is suitable for freshers. Qualifications required are B.Pharm / M.Sc. / M.Pharm. Preferred skills include good communication and analytical skills, as well as the ability to work well in a team in order to complete tasks in a timely manner. The detailed responsibilities of the role include bioanalytical sample preparation using various extraction techniques, conducting method development, method validation, and sample analysis in accordance with regulatory requirements, operating laboratory equipment such as pipettes, centrifuges, evaporators, and extractors, as well as handling data generation, compilation, and reporting of results.,

You will be joining the Bio Analytical Department at PTC - MORAIYA as a Probationer-R&D Executive. With 2-3 years of experience and an educational background in M.Sc or B. Pharma, you will be responsible for various tasks including sample preparation, method development, method validation, and subject sample analysis. Your role will involve operating, calibrating, and maintaining equipment while keeping track of the equipment log. You will also be required to review bio analytical data, prepare and review SOPs, protocols, plans, and reports. Additionally, you will play a vital role in executing and maintaining GLP, GCP, Safety, and Quality systems within the department. Maintaining displays ...

You should have 16-20 years of experience in the pharmaceutical industry and be located in Pithampur. A degree in M.Sc./ M. Pharma / B. Sc. / B Pharma is required for this position. Your responsibilities will include daily planning of analytical activities, resource management, and work allocation. You will be responsible for planning and executing sampling and analysis for raw materials, packaging materials, intermediates, and finished products. You will review and/or approve the implementation of standard operating procedures, analytical protocols, and analytical reports. Additionally, you will review and/or approve the qualification and calibration of instruments. You will investigate and...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Role & responsibilities 1) Planning of analytical activity for assign Projects. 2) Review of Routine (F & D) and stability sample analysis as assign Projects and compilation. 3) Review of Specifications and Standard Test Procedures of Raw Materials, Finished Product for assign Projects. 4) Review of Analytical method development, partial validation and API Verification for assign Projects. 5) Maintain GLP in the laboratory as per regulatory requirement. 6) Proper Training to subordinates regarding Good documentation and GLP. 7) Proper archival of all laboratory documents (Analytical reports). 8) Proper utilization of laboratory equipment and person day to day. 9) Support to F&D, QA, QC and R...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 19-07-2025. 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...

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, GTI s on different ...

You are being hired for the position of QC Head at our company based in Ankleshwar, Gujarat. As the QC Head, you will be responsible for ensuring the quality of all batches manufactured, overseeing the Quality Control department functions, and managing activities related to quality assurance. Your main duties will include sampling, inspection, and testing of raw materials, packaging materials, in-process products, and finished products as per specifications for release or rejection. You will also be in charge of stability chamber handling, stability testing, and evaluation of shelf-life of products, as well as preparing stability testing protocols and reports. In addition, you will conduct m...