489 Method Validation Jobs - Page 18

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical a...

Role & responsibilities Responsible for performing and overseeing ELISA (Enzyme-Linked Immunosorbent Assay) testing, ensuring high standards of accuracy, quality control, and efficiency in laboratory operations. This role involves leading a team of technicians, optimizing assay protocols, managing lab inventories, and analyzing data. Deliver GLP and non-GLP ELISA/LBA, MSD ECL, and Luminex Multiplex Analysis for Pharmacokinetic (PK), Toxicology (Tox), Biomarker, Bioavailability (BA), Biosimilar, Immunogenicity, and other bioanalytical studies. Complete Method Development or Method Transfer of customized, robust, and highly sensitive Chromatographic Assay using necessary sample preparation Dev...

Roles and Responsibilities Conduct bioanalytical research activities such as method development, validation, and sample analysis using techniques like HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. Develop and validate methods for bioanalysis of biologics and biosimilars according to regulatory requirements (e.g., USFDA). Collaborate with cross-functional teams to ensure timely delivery of high-quality results. Perform stability testing of biological products under various conditions. Troubleshoot issues related to instrument calibration, maintenance, and operation. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Phar...

Ajanta Pharma is looking for Research Associate- Method Development- Ophthalmic to join our dynamic team and embark on a rewarding career journey Design and validate analytical methods for ophthalmic drugs Conduct laboratory testing and data interpretation Ensure regulatory compliance and documentation accuracy Collaborate with R&D and QA for development alignment

Instrument Handling - pH Meter, Analytical Balance, Friability Tester, Disintegration Apparatus, Hot Air Oven, Moisture Balance, UV Sprct. Raw & Packing Material Testing Strong GLP Adherence Robust GMP Documentation Regulatory Compliance Awareness Required Candidate profile Experience: 2–3 years in pharmaceutical Quality Control Strong knowledge of analytical instruments and QC procedures Soft Skills: Detail-oriented, organized, good interpersonal & communication skills

*Greetings*!! *We Are Hiring_Quality Control _ Chennai Location* *Education*- B.Sc / M.Sc *Experience* - 2 to 5 Years *Location* - Chennai *Preferable Candidate from only Pharmaceutical Manufacturing* Key Skills - handling HPLC , QMS , Raw materials and Wet Analysis For more details and to apply, please reach out at pna@softgelhealthcare.com or call 8608396077 References will be highly appreciated

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.

Responsibilities: * Ensure compliance with regulatory standards * Conduct chemical testing and method validation * Collaborate with R&D team on product development * Manage quality control processes from start to finish

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

GTI & NDSRI by using LCMS. Review of Method Development & Method Validation Data Preparation of Protocols & Validation Reports Handling of Incidents, Deviations & Change Controls.

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in so...

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in so...

Roles and Responsibilities Conduct stability studies, method validation, and analysis of finished products using techniques such as GC, HPLC, UV-Vis, KF, FTIR, and dissolution testing. Ensure compliance with GLP guidelines and maintain accurate records of all experiments and results. Collaborate with cross-functional teams to resolve issues related to product quality control and manufacturing processes. Develop and implement new methods for analyzing raw materials, intermediates, and finished products. Participate in method development activities to improve existing methods or develop new ones.

Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic d...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- Holi Child School, Near Dundigal Police Station, Gandi Maisamma on Saturday 31-05-2025. 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 ...

Department: Quality Location: Kurla Travel: Low Job Overview: Remote support to PPL sites in reviewing analytical data remotely, preparing master build in LIMS (Lab Vantage / Labware), Document Preparation (specifications, test methods, protocols, etc.) and uploading for review in ensure, initiating QMS elements in Trackwise / eDMS. Key Stakeholders: Internal Site Quality Team (QC, QA), Corporate Functions Key Stakeholders: External Regulators (during inspection), Solution Providers Reporting Structure PPL Site Quality (Functionally) and CQA Document, Data Review & Creation (Administratively) Qualification B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology Exp...

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- Qualychrome Research Labs, H.No .5-5-35/128, plot no.177, near Venkateswara Swamy temple, Prashanti Nagar, Kukatpally, Hyderabad, Telangana on Saturday 31-05-2025. 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, w...

About the Role We are currently seeking a data-driven and detail-oriented Program Intern to join the Founder’s Office. This role will involve critical thinking, problem-solving, and analytical thinking to drive operational improvements and support strategic initiatives. The charter for this role will include Work closely with the founder/senior leaders to turn ideas into validated experiments. Dive into industry trends, discover competitor insights while also working on user research. Build a hypothesis to solve the different problem statements, execute, validate and scale the results Align with stakeholders across the org to drive the actionables; be a driving force in cross-functional team...

We are seeking a skilled Analyst with hands-on experience in HPLC or GC or ICP techniques. The candidate should be well versed with Method Development, Method Validation and Method Transfer. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Mohali) Accountabilities: This position is accountable for critically reviewing any data and documents generated in Quality Control Laboratory as well as executed Batch records which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Ensure during pre-submission review of all data pertaining to submission to USFDA that all Finished products, Drug Substances, Intermediates, Raw materials and Packaging materials are tested as per approved procedures under cGMP conditions and documented precisel...

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Gurugram) Accountabilities: This position is accountable for critically reviewing data and documents generated by Analytical Research Department and Product/Packaging development department which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Responsibility: Perform thorough review of raw data (pertaining to R&D related activities (viz. Analytical Method Validations /Analytical reports / Analytical Method Transfer / Product Development Report etc. ) compiled by respective department & alr...

• Perform analytical testing using advanced instruments like HPLC and GC. • Conduct dissolution analysis using HPLC and UV methods • Carry out method verification and transfer for various analytical procedures

Walk-In Drive : Analytical Services Required Qualification & Experience: M.Sc. Chemistry/Analytical/M-Pharmacy, with 0 - 3 Years of experience in the field of pharmaceutical industry/CRO setup. Candidate should have knowledge in method development and validations by GCMS /LC-QTOF. Candidate should have knowledge on GLP/cGMP. Good to have experince in E&L. Job Responsibilities Carries out experimentation in the area of GCMS/LC-QTOF for E&L studies. Records experimental data, ensuring clear and accurate transcription of results and calculations. Completes assigned work with quality and in a timely manner. Assists the group leader in instrument qualifications, implementing laboratory procedures...

a. Candidates should have hands on experience in qualification and calibration of instruments like HPLC/Dissolution/UV/GC/IR/KF. b. Candidate should be well conversant with GXP, QMS and SOPs preparation. c. Should able to work on software like Empower, LIMS, Nichelon, QAMS & DMS. d. Qualification : M.Sc ./M. Pharma/B. Pharma. e. 4-7 years of experience will be preferred

The Opportunity Avantor is looking for an Associate for the Customer Support team. Its an entry level position; provide initial technical product support to customers by handling inquiries and troubleshooting basic technical product-related issues. Gather information to identify and assess the nature of the problem. Record incident in a tracking system to maintain log of product issues for escalation and product development teams. Typically refer to transcript or established process in training manuals and guides to recommend solutions. Escalate complex issues to higher-level technical product support specialists or management. What were looking for Education: Post-secondary education or equ...