356 Method Validation Jobs - Page 7

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause. To use Rubrics template for investigation report writing. To provide appropriate support to site in preparing for or during regulatory inspection for investigations. Qualification looking someone with strong QC investigation background, QC Compliance, Analytical development Education :B.Pharm, M.Sc, M.Pharm Exp : 8-10 Years Industry : OSD preferred/ Injectable, API also work Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

We are looking for a skilled R & D (Analytical Development) Professional with 4 to 9 years of experience to join our team. The ideal candidate will have a strong background in analytical development and excellent problem-solving skills. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance product quality. Collaborate with cross-functional teams to design and execute experiments and tests. Analyze data and results to identify trends and areas for improvement. Design and develop new products and processes using analytical techniques. Conduct research and stay updated on industry trends and developments. Provide technical support and guidance to junior team members. Job Requirements Strong knowledge of analytical techniques and methodologies. Excellent problem-solving and communication skills. Ability to work independently and as part of a team. Strong attention to detail and organizational skills. Experience with data analysis and interpretation. Familiarity with industry standards and regulations. Minimum of 4 years of experience in the field, preferably in an employment firm or recruitment services firm.

R & D (Analytical Development) - Agrochemical Industry-Saykha,Gujarat. Industry Engineering Engineering Design R&D Quality Qualification Key Skills Green Field Projects UPLC R & D Analytical Development Chemical Research Chemical Chemical Analyst Analytical Chemical Analytics We are looking for a skilled professional with 5 to 11 years of experience to join our team as an R & D (Analytical Development) specialist. The ideal candidate will have a strong background in analytical development and excellent problem-solving skills. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance laboratory efficiency. Collaborate with cross-functional teams to design and execute experiments and studies. Analyze data and results to identify trends and areas for improvement. Design and develop new instrumentation and equipment to support analytical activities. Provide technical guidance and support to junior staff members. Stay up-to-date with industry developments and advancements in analytical technologies. Job Requirements Strong knowledge of analytical techniques such as HPLC, GC, and Spectrophotometry. Experience with data analysis and interpretation software. Excellent problem-solving and communication skills. Ability to work independently and collaboratively as part of a team. Strong attention to detail and organizational skills. Familiarity with laboratory safety protocols and procedures.

R & D (Analytical Development) - Agrochemical Industry-Saykha,Gujarat. Industry Pharma R&D Biotech Qualification M.Sc Key Skills R & D Analytical Development LAB Agrochemical UPLC Green Field Projects HPLC Chemical Research We are looking for a skilled professional with 5 to 11 years of experience to join our team as an R & D (Analytical Development) specialist. The ideal candidate will have a strong background in analytical development and a passion for driving innovation. Roles and Responsibility Develop and implement new analytical methods and techniques to drive business growth. Collaborate with cross-functional teams to design and execute experiments and studies. Analyze data and results to identify trends and areas for improvement. Design and develop new products and processes using analytical techniques. Conduct literature reviews and stay updated on industry developments. Provide technical support and guidance to junior team members. Job Requirements Strong understanding of analytical principles and techniques. Experience with experimental design and data analysis. Excellent problem-solving and communication skills. Ability to work independently and as part of a team. Strong attention to detail and organizational skills. Familiarity with industry standards and regulations.

Department : Analytical R&D Open Positions : LCMS, HPLC, Wet Lab, Solid state characterization and DQA Work Locations : Shameerpet, Hyderabad Job Description: Need to have strong theoretical knowledge (HPLC/LCMS/WETLAB) Plan and conduct the analysis with required skills. Record the observations meticulously and update to the TL/SME. Share and discuss the observations with supervisor. Independent in maintaining the instrument and setting up the instrument for analysis. Expected to be aware of basics in analytical chemistry (basic analytical techniques Theory and application) as well as handling of laboratory equipment / instruments with basic understanding. Expected to be aware and working in a safety compliant manner

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. Experience in making lab SOPs and study reports 6+ yrs of Agrochemicals/chemicals in Green field/brown field Projects Exp in handling instruments like UPLC, LC-MS , GC, ICP-OES, XRD & DSC

Job Title -Manager Research & Development(R&D) - Agrochemical Qualification: MSc (Organic Chemistry with first class), Experience: 4+ years in R&D Industry- Leading pharma, CRO (Contract research Organization), Agrochemicals JOB DUTIES AND RESPONSIBILITIES (Please mention in below table) Plan, setup, monitor, and workup chemical reactions independently Monitor progress of the reactions by using standard methods and analytical techniques (TLC, GC, HPLC, LCMS etc) Isolate product and Optimize reaction conditions for improved yields and output Purify compounds by different methods using chromatography, distillation and crystallization etc. Characterization and identification of compounds using UV, IR, NMR, LCMS and GCMS etc Ensure parallel execution of multiple reactions conducted both by self and the team Scale up of R&D developed products to kg scale and then technology transfer to pilot plant Troubleshoot as appropriate for successful execution with intimation to supervisor Experience 8 - 14 Years Industry Engineering Engineering Design R&D Quality Qualification M.Sc, Ph.D/Doctorate Key Skills Research & Development R&D Chemist Research & Development Executive HPLC UPLC GC R&D Manager

Role & responsibilities Sample analysis & Method Validations under the guidance of Section In-Charge Understanding the complete requirement of the method before initiating the analysis Maintenance of all logbooks of equipment being used in section Working reference standard preparation Maintenance of records for working reference standards with their logbooks under the supervision of Section In-Charge Glassware calibration Intermediate checks of equipment under the supervision of Section In-Charge Specific responsibility of the assigned instrument (AAS/ICP-MS, GCMS-MS, LCMS-MS, IRMS) Calculating uncertainty of measurement for different parameters Responsible for calibration, maintenance and uncertainty calculation of the specified instruments under the supervision of Section In-Charge Any other assigned work We are Looking for You with Qualification B.Sc./ B.Tech./ M.Sc./ M.Tech./ Equivalent degree in Biochemistry/ Biotechnology Technical Certifications Authorized Signatory would be an added advantage Experience 3 to 4 years of relevant experience required Expertise at Instrumentation/ Chemical Testing Working on Instrument like AAS/ICP-MS, GCMS-MS, LCMS-MS, IRMS (as per specific requirement) Behaviours & Aptitude Team Player Good Listener Positive Attitude Solution Oriented

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 Preparation and review of Specifications, Method of analysis procedures and Analytical development reports Experience in making lab SOPs & study reports.

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

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