371 Method Validation Jobs - Page 8

Position: ADL Executive Location: Torrent Research Centre - Gandhinagar, Gujarat Experience required: 3 to 8 Years in ADL Method Development for Formulation Qualification: M.Sc./M.Pharm Required Experience HPLC/GC method development for OSD having exposure to regulated, Semi Regulated & India markets including: Complex generic, F2F, Topical & Dermaceuticals, Peptides, Oncology NI/GI & NDSRI' with LCMS/GCMS expertise, Solid state characterization, Microbiology (Probiotic subject matter expert). Job Description To develop analytical method for Assay, Related Impurity (Degradation Product), Content uniformity, Dissolution and other related tests Dissolution testing and evaluation. Analyzing formulation and raw materials Performing pre-formulation analysis To analyze formulation trials To analyze stability samples of development trials Literature review for drug substance (API) and drug Product (Formulation) To prepare reference and working standards Preparation of Analytical Method Development Report Preparation of analytical methods and COA (Certificate of analysis) To update instrument log book entries

1 Perform the testing of Raw Material/Finished goods/In process materials and report the results. 2 Handle the analytical instruments like HPLC, UPLC, GC, ICP, DSC, XRD, PSAetc 3 Calibration of the Analytical instruments as per the master calibration schedule 4 Investigate the analytical error/deviations during analysis and find out the root cause. propose appropriate corrective and preventive action for the same 5 Experience in making lab SOPs and study reports 6 Execute method validation and prepare the necessary reports 7 Reviews analytical chemistry testing records of raw materials, stability, and product for accuracy and adherence to test methods 8 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 9 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 10 Discuss work plan on daily basis with supervisor/ manager and Mentor junior lab personnel 11 Participate in project meetings and prepare weekly and monthly reports and submit to Manager 12 Regular lab duties including equipment maintenance, chemical inventory and lab clean-up 13 Maintain strict IP Confidentiality and adhere to all related data privacy policies

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 Required Candidate profile Experience in handling instruments like UPLC, LC-MS , GC, ICP-OES, XRD and DSC.

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 Required Candidate profile Experience in handling instruments like UPLC, LC-MS , GC, ICP-OES, XRD and DSC.

Setting strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art separation techniques (HPLC/UPLC/LCMS/GC) and familiar with XRD, DSC etc and automation Troubleshoot as appropriate for successful execution with intimation to supervisor Scale up of R&D developed products to kg scale and then technology transfer to pilot plan Required Candidate profile Preparation and review of Specifications, Method of analysis procedures and Analytical development reports Feel free to reach me on email

Company Name: Paushak Limited (Alembic Group company) Position: Research Associate Department: Research & Development Location: Halol, Vadodara Industry: Chemical / Agro Chemical / Specialty Chemicals Experience Required: 2 to 8 Years Education: M.Sc Organic Chemistry Job Responsibilities: Conduct literature reviews to support project planning and development. Perform process development , optimization , and scale-up of assigned chemical projects. Engage in method development and wet chemical analysis . Operate and maintain analytical instruments including HPLC , GC , and other lab equipment. Handle specialty chemicals with appropriate safety and analytical protocols. Support calibration, preventive maintenance, and troubleshooting of lab instruments. Maintain accurate documentation and records of experiments and results. Collaborate with cross-functional teams to ensure smooth project execution. Skills Required: Strong foundation in organic chemistry and chemical process development. Hands-on experience with HPLC , GC , and other analytical instruments. Proficiency in wet analysis and method development techniques. Ability to handle and analyze specialty chemicals safely and effectively. Good organizational and documentation skills. Effective communication in English, Hindi, and Gujarati.

Company Name : Paushak Limited (Alembic Group company) Position: Executive Sr. Executive (ADL) Department: Analytical Development Group Location: Halol, Vadodara Industry: Chemical / Agro Chemical / Specialty Chemicals Experience Required: 2 to 8 Years Education: M. Sc Organic Chemistry Job Responsibilities: Prepare and standardize volumetric solutions. Handle analytical instruments including HPLC, GC , and other lab equipment. Perform wet analysis, including calibration, preventive maintenance, and troubleshooting. Conduct method development for analytical procedures. Carry out stability studies for new products. Perform in-process and finished product analysis and reporting. Maintain daily analysis records and manage chemical and instrument inventories. Oversee column management, data backup, and waste management. Handle specialty chemicals with appropriate safety and analytical protocols. Skills Required: Proficiency in handling HPLC, GC , and other laboratory instruments. Strong experience in wet analysis and method development . Expertise in handling and analyzing specialty chemicals . Strong organizational skills for managing chemical stocks, instrument parts, and documentation. Familiarity with calibration protocols and stability testing.

Department - R&D (Synthesis) Qualification :- MSc (Organic chemistry) Reporting To :- R&D Manager JOB DUTIES AND RESPONSIBILITIES (Please mention in below table) 1. Plan, setup, monitor, and workup chemical reactions 2. Monitor progress of the reactions by using standard methods and analytical techniques (TLC, GC, HPLC, LCMS etc) 3. Isolate product and Optimize reaction conditions for improved yields and output 4. Purify compounds by different methods using chromatography, distillation and crystallization etc. 5. Characterization and identification of compounds using UV, IR, NMR, LCMS and GCMS etc 6. Ensure parallel execution of multiple reactions conducted both by self and the team 7. Scale up of R&D developed products to kg scale 8. Coordinate with senior team members to manage & deliver projects on time with high-quality standards of the deliverables 9. Regular lab duties including equipment maintenance, chemical inventory and lab clean-up 10. Participate in project meetings and prepare daily, weekly and monthly reports and submit to Manager 11. Maintain strict IP Confidentiality and adhere to all related data privacy policies 12. Participate in project meetings and prepare daily, weekly and monthly reports and submit to Manager

1 Plan, setup, monitor, and workup chemical reactions 2 Monitor progress of the reactions by using standard methods and analytical techniques (TLC, GC, HPLC, LCMS etc) 3 Isolate product and Optimize reaction conditions for improved yields and output 4 Purify compounds by different methods using chromatography, distillation and crystallization etc. 5 Characterization and identification of compounds using UV, IR, NMR, LCMS and GCMS etc 6 Ensure parallel execution of multiple reactions conducted both by self and the team 7 Scale up of R&D developed products to kg scale 8 Coordinate with senior team members to manage & deliver projects on time with high-quality standards of the deliverables 9 Regular lab duties including equipment maintenance, chemical inventory and lab clean-up 10 Document reactions, research findings/ observations accurately in lab note books to ensure data integrity 11 Participate in project meetings and prepare daily, weekly and monthly reports and submit to Manager 12 Maintain strict IP Confidentiality and adhere to all related data privacy policies Sheetal Tanwar

JOB DUTIES and RESPONSIBILITIES (Please MentionInBelow Table) 1 Perform the testing of Raw Material/Finished goods/Inprocess materials and report the results. 2 Handle the analytical instruments like HPLC, UPLC, GC, ICP, DSC, XRD, PSAetc 3 Calibration of the Analytical instruments as per the master calibration schedule 4 Investigate the analytical error/deviations during analysis and find out the root cause. propose appropriate corrective and preventive actionforthe same 5 Experienceinmaking lab SOPs and study reports 6 Execute method validation and prepare the necessary reports 7 Reviews analytical chemistry testing records of raw materials, stability, and productforaccuracy and adherence to test methods 8 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 9 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 10 Discuss work plan on daily basis with supervisor/ manager and Mentor junior lab personnel 11 Participateinproject meetings and prepare weekly and monthly reports and submit to Manager 12 Regular lab duties including equipment maintenance,chemicalinventory and lab clean-up 13 Maintain strict IP Confidentiality and adhere to all related data privacy policies

Job Overview: To perform AR&D actives as per GMP & Safety Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Job Description Timely perform and plan for Calibration and maintenance of instruments. Preparation, sterilization and disposal of microbiological media and accessories. Planning and execution of Water sampling and testing (Microbial and Chemical) of OSD and Ophthalmic facility. Preparation of trend for water system and environmental monitoring. Perform the Environmental monitoring of Sterility area, Ophthalmic and OSD facility and participation in media fill activity. Planning and execution of Microbial analysis of raw material, packing material, intermediate / in-process samples, Finished Product and Stability samples for Sterility testing, Particulate matter testing, Bacterial Endotoxin testing, Antimicrobial effectiveness testing, Bio burden testing and Packing material testing. Planning and execution Growth promotion testing, Preparation of microbial culture suspensions, maintenance of microbial culture and Identification of microorganisms. Planning and execution of online documentation, Upkeep of housekeeping in laboratory. Preparation of method validation MET / Sterility / BET / other miscellaneous protocol for validation study. Proper arrangement of samples and analysis of samples performed within time line. Report any quality concerns or suggestions for improvements to Supervisors/managers. Handling of water, calibration and purchase activity through SAP. Ensure timely initiation and closure of QAMS documents such as lab incidence. Handling of all microbial testing and calibration of instrument/Equipment through LIMS. Responsible to person any other task/activity assigned by supervisor /Manager. Work Experience Experience :- 2 to 4 yrs. Education Masters in Microbiology Competencies

Responsibilities: * Develop analytical methods using HPLC techniques. * Ensure compliance with regulatory requirements through method validation. * Collaborate on formulation projects from concept to launch. Provident fund Health insurance

1.Setting strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art separation techniques (HPLC/UPLC/LCMS/GC) and familiar with XRD, DSC etc and automation 2.Communicate with synthesis-R&D and lead assist in analytical method remediation/troubleshooting 3.Perform analytical characterization and data interpretation for complex organic compounds 4.Experience in making lab SOPs and study reports 6.Develop analytical methods that are accurate, precise, specific, and robust 7.Calibration of the Analytical instruments as per the master calibration schedule 8.Preparation and review of Specifications, Method of analysis procedures and Analytical development reports 9.Discuss work plan on daily basis with supervisor/ manager and Mentor junior lab personnel 10.Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.). 11.Participate in project meetings and prepare weekly and monthly reports and submit to Manager 12.Preparation of analytical technical documents for dossier Technology transfer executions of the projects. 13.Regular lab duties including equipment maintenance, chemical inventory and lab clean-up 14.Maintain strict IP Confidentiality and adhere to all related data privacy policies

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC/GC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. 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

Method Development of Assay, Dissolution and related substances, Method validation, Calibration of analytical instruments, Routine and stability samples analysis of OSD formulations, Good quality mind set and should understand GLP requirements technical report writing and power point presentation preparation. Responsibilities Qualifications M.Sc. chemistry/ pharmaceutical chemistry/ organic chemistry. Pharma ( QA, pharmaceutics)

Designation - QC Officer-Sr. Officer Location - Daehj Experience - 2 to 5 year Qualification: B.Pharm / M.pharm / M.sc (Chemistry) Required Candidate profile Roles and Responsibilities: 1.Experience in Section LCMS / PSD / HPLC / GC /Method Validation 2.Candidate preferred from Pharma API (Active Pharmaceutical Ingredient).

Business: PPL Digwal Department: PTS Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Department: PTS Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Business: PPL Digwal Department: PTS Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Please find below JD for position in Research & Development at Intas Plasma Fractionation Centre based in Ahmedabad dealing in Plasma Protein Products : Roles and Responsibilities - Characterization of plasma proteins by various physicochemical methods - Responsible for stability sample analysis by different methods and its data management - Analytical Method Qualification and Analytical Technology transfer - Method Development & Troubleshooting - Instruments Handling/ Techniques: SDS-Page , HPLC , GC, IEF and Western blot, ELISA - Reference standard qualification, instrument & micropipette calibration - Responsible for document preparation/review of LPs, MOA, MQP, MQR,TTD and documentation of related activities Desired Candidate Profile Candidate should have experience in biopharma/ biotech industry

Job Description Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Under general supervision of lab team leader, independently perform routine scientific research tasks using standard techniques, procedures and equipment. Adapt and optimize or develop new methods and procedures, actively contribute to technical solution finding process. Propose solutions and discuss with manager Show engineering and tech transfer proficiency Assist and support to R & D team and cross functional team in scale-up of new products technology Troubleshoot & or improve existing processes Summarize and document results in lab journal, prepare technical reports. Maintain clean working laboratory environment and suitable working equipment. Perform general lab assignments (e.g. raw material inventory review, lab instruments ) as assigned. Comply with regulations concerning safety, health and environment

1.Good Communication skills, 2.Method Validation 3.Instrumentation knowledge of LCMS & GCMS Qualification :M.Sc(Oraganic Chemistry/Analytical Chemistry) / M.Pharma