489 Method Validation Jobs - Page 9

Must Abide by the rules & regulations of the laboratory. Responsible for Performing tests as per authorization and ensuring the TAT Compliance. Ensure Safe Handling of Equipment’s. Filling all logbooks for the equipment’s as per usage Ensure to wear all the PPE’s and lap aprons before performing the tests without fail. Ensure to follow safety rules & Maintain 5S. Pesticides & Mycotoxins analysis in food & agriculture as per authorization. Follow ISO 17025 requirements in lab with respect to Quality compliance and other regulatory requirements. Internal calibration of equipment’s Maintenance. Handling, Operating & Calibration, Maintenance of LC MSMS. Handling, Operating & Calibration, Mainten...

1. Supervise end to end operations of food Chemical lab maintain the TAT for all the samples. 2. Implementation of Quality System as per all applicable accreditations like ISO 17025, FSSAI, EIC, APEDA etc. 3. Maintain all relevant documentation and presents as needed for quality audits and Regulatory audits 4. Implementation and Complying to the other TUV SUD Process and Policies 5. Implementation of good laboratory practices 6. Ensure on time method development / verification and validation 7. Implementation of any new process as decided by the management 8. Monitoring the turnaround time of the sections / reports as per the given schedule 9. Testing capability confirmation to sales and co-...

Job Title: Invitro BA Scientist Job Location: Bangalore, Hyderabad' About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines • Overall adherence to safe practices and procedures of oneself and the teams ...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 25-07-2025. 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 i...

Conduct quality control tests on API samples using various analytical techniques such as HPLC, GC, UV, etc. Method Verification, Calibration

Should be capable of handling instrument like HPLC, GC , UV, IR and potentiometry Should have the GMP knowledge and compliance requirement of QC Should have the knowledge on Good laboratory practices .

Role & responsibilities Required for Quality Control(Formulations) Quality Control(QC)- Need 1 to 5 years of experience. *Analysis of Finished Product & Stability *GLP and LIMS, Documentation Preferred candidate profile Perks and benefits

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).

Exp: 2- 6 yrs • Knowledge in Method Development on Assay, RS, dissolution for formulation complex molecules. • understanding of Q1/Q2 evaluation • PEQ processes and characterization • Instruments: HPLC, GC, KF, UV, IR, etc. pranathi.p@orbicular.co.in

Aspirant should have experience in GC-MS Caliber to handle Method Development, Validation, and Stability studies. Regulatory requirements (like USFDA, MHRA, EMA, and other Markets) Coordinating with the Should have GLP, ALCOA+, GDP, QMS

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis 32S/32P Reference Standards 32S/32P Characterization of Impurities 32S/32P Justification of Specification 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report bas...

NOTE: Only Male & Candidates from AP & Telangana Preferred. Kindly Understand the JD It's not for the Clinical Trails Department 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Qualifications required: Bachelors / Master's in Pharmacy, M.sc Chemistry/Organic Chemistry (2023/24/25 Passed outs with certificates in hand) Role and responsibility: In process quality control of ongoing studies. Review of raw data, chromatograms and reports of the method validations and studies. Checking of all the instruments and equipments for the calibration status and appropriate labeling. Checking and monitoring of the day-to-day activities in the lab for compliance to...

As a member of our team, your primary responsibilities will include the development and validation of methods for Assay, Dissolution, and related substances. You will also be responsible for the calibration of analytical instruments to ensure accurate and reliable results. Conducting routine and stability samples analysis of OSD formulations will be a key part of your role. To excel in this position, you must possess a good quality mindset and have a thorough understanding of GLP requirements. Your ability to write technical reports and prepare power point presentations will be essential for effectively communicating your findings and recommendations. Join us in this dynamic role where you w...

You will be joining USP's Global Biologics department as a Sr. Scientist - I (RSS-Review), where you will play a crucial role in supporting the development of USP documentary standards and reference standards for biological products. In this hands-on, non-supervisory position, you will be responsible for ensuring the accuracy, clarity, and compliance of scientific documents, managing the reference standard stability program, and driving continuous process improvements. Your primary responsibilities will include performing technical and quality reviews of documents, developing and reviewing SOPs and training materials, assisting in investigations of quality-related issues, and collaborating w...

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