362 Method Validation Jobs - Page 15

Aragen Life Sciences is seeking an HPLC expert for the position of Analytical Research Scientist to execute method development & validations focused on the API of new chemical entities (NCEs) and generics. The ideal candidate should possess a strong understanding of the fundamentals of analytical chemistry and HPLC combined with expertise in method development and validation based on sound scientific principles.

Principal task: Analytical Method Development by HPLC for all Project. Review the analytical method development data, validation study data and method transfer protocol and reports. Calibration of HPLC system. To maintain GLP/GDP in working environment. Preparation of analytical data and submit for review. Analytical Method Development and Validation. Responsibilities: Calibration of HPLC’s as per SOP and maintenance of HPLC Systems. Maintaining record for all analytical reports by entering all the data in raw data note book and timely release of analytical reports. Preparation & Review of analytical method validation protocol and report as per the current regulatory requirement. As per Protocol, perform the Analytical method validation of RS, Assay and Chiral for KSM, Intermediate and Finish product of compendia and non-compendia compound. Preparation & Review of Protocol & report of analytical method transfer report. Maintain records for all analytical reports by entering all the data and timely release the analytical reports to concern department.

Knowledge on how to develop the LCMS / HPLC suitable method from the GCMS method.Preferable to handling of LC-HRMS instrument and technical knowledge on E & L studies.Method development for GTIs and Nitrosamines by LCMS.Collect the literatures.

Serves as lead engineer on mid- to large size projects. Provides specialized technical input to studies and design for staff's specific area of expertise. Approves and signs off on work. Provides technical expertise for studies and design efforts. Presents complex technical solutions to clients. Performs quality control reviews of work developed by others. Participates in development of technical proposals. Provides estimates for the engineering budget and schedule to meet requirements on large projects.

Responsibilities: Responsible for Documentation work in QC Department Candidate must have Experience of HPLC , GC & Wet Analysis. Shall maintained all records related to manufacturing Overall looking after the complete filling, packing activities and Procurement of the packing material. To ensure the compliance of safety Requirement Cleanliness Hygiene and Environment in Working Areas. Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity. Required Skills: Team player Good in communication Required Qualification: - B.Sc/M.Sc - Chemistry

Responsibilities: To follow Good Laboratory Practices. Carry out routine analysis & Ensure documents pertaining to day to day analysis. Calibrate instrument used for analysis as per SOP and maintain its record. Method Transfer Activity. Should have experience of handling and calibration of GC, HPLC, KF, UV, Viscometer, Potentiometer, Tintometer, PH Meter etc. Various analyticals methods development and wet analysis along with related documentation. Required Skills Must be excellent in written and spoken English; Net savvy and adept at computer skills. Good in communication. Required Qualification : - B.Sc/M.Sc - Chemistry

Responsibilities: Responsible for Documentation work in QC Department Candidate must have knowledge of HPLC/GC. Responsible for manufacturing the batch as per MOM or BMR. Shall maintained all records related to manufacturing Overall looking after the complete filling, packing activities and Procurement of the packing material. To ensure the compliance of safety Requirement Cleanliness Hygiene and Environment in Working Areas. Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity. Required Skills: Must be excellent in written and spoken English; net savvy and adept at computer skills Attention for detail Team player Good in communication Required Qualification : - B.Pharm/B.Sc/M.Sc - Chemistry

Position: Pre-Clinical Designation: Research Associate Job Location: Dholka, Gujarat 1. Study Sample Analysis- Clinical studies 2. Method Development and Method Validation - Preparation of STP And MVP 3. Coordinate with QA & QC department for timely completion of Projects reports 4. Preparation of SOP and method development and method validation documents 5. Maintaining GLP & ensure 100% compliance

Role & responsibilities 1) Responsible for Laboratory execution of analytical activities on daily basis and ensuring compliance to the Safety and quality system as per cGMP. 2) Responsible for Laboratory execution of instrument calibration, stability analysis, WRS preparation/Qualification and for procurement of reference standard etc. 3) Responsible for maintaining stock of working reference standards and chemicals required routinely for raw material analysis. 4) Review and release of finished product, inprocess, intermediates, raw material, reaction monitoring results. 5) Responsible for Laboratory execution of analytical method validation/Verification and Method Transfer activites. 6) Coordination for reagents and volumetric solutions preparation, standardization and maintenance. 7) Coordination for maintaining analytical columns of HPLC, GC, IC and spare parts of instruments and Equipments. 8) Coordination of AMC / CMC of analytical laboratory instruments and its calibration. 9) Coordination for disposal of retained analytical samples of raw material, packing material, inprocess and stability samples. 10) Preparation, revision, review and checking of Raw material, inprocess, intermediates, reaction monitoring and finished products specifications and test procedure and departmental SOPs. 11) Planning and execution to review, checking of IQ, OQ and PQ documents of instruments and equipment. 12) Prepare and Review of certificate of analysis (COA) for finished products. 13) Responsible for investigation of incidents and Deviations in coordination with internal and cross functional team 14) Complying EHS promotional activities and complying EHS statutory requirements of the analytical department. 15) Handling of the ICP-MS/ ICP-OES, Ion Chromatography, GC-MS, UPLC,ION Meter and commissioning experience of the product and new Laboratory setup. Job specification: Experience : 6-10 Years Qualification : M.Sc Analytical Chemistry or M.Sc (Chemistry with large industrial experience in analytical method development and structure elucidation.)

Conduct analysis of pharmaceutical products using HPLC. Develop & validate analytical methods. Documentation & Reporting. Calibration & maintenance of analytical instruments. Participate in regulatory inspections and audits, Required Candidate profile Experience of Pharma companies is mandatory. Should be aware of QMS related to QC. It is on the rolls of Cotecna Life Sciences. Share resume on nilesh.kadam@geochem.net.in or call on 9870476784.

1. Develop, validate, and optimize analytical methods for raw materials, intermediates, and finished products. 2. Perform stability studies, impurity profiling, and release testing in line with ICH and regulatory guidelines. 3. Prepare comprehensive documentation, including method development reports and validation protocols. 4. Collaborate with formulation scientists to support product development and scale-up. 5. Troubleshoot analytical methods and instrumentation, ensuring efficient lab operations. 6. Ensure compliance with GMP, GLP, and regulatory standards within ADL.

Role & responsibilities Handling of Analytical Method validation of Assay and dissolution as per ICH Guidelines. Responsible for the Analysis of Finished products as per STP. Responsible for the Qualification and Maintenance of Working Standards. Responsible for sending of samples to external laboratory and receiving of reports. Maintenance of records / documents for external laboratory services. Dissolution: Carrying out different Media study with compilation of results. Regular Stability Analysis: Well versed with handling of regular Stability samples analysis. Operation and regular maintenance of stability chambers. Documentation: Good knowledge on GLP, GDP, CGMP and maintenance of records, usage logbooks. Preparation of Standard testing procedure for API, In process and finished products, Responsible for report preparation after completion of the analysis. Responsible for generating COAs for working standards and finished products. Responsible for Protocol based studies. OPERATION AND CALIBRATION OF THE FOLLOWING INSTRUMENTS: Knowledge on HPLC with Empower 2 and 3 Software. (UV/PDA) Knowledge on UV-Visible Spectrometer. Knowledge on Dissolution Tester. Knowledge on Operation and Maintenance NOTE: Immediate joiners pereferable