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3.0 - 8.0 years
4 - 6 Lacs
Bharuch
Work from Office
Plan, setup, monitor, &workup chemical reactions independently. Monitor progress of the reactions by using standard methods & analytical techniques (TLC, GC, HPLC, LCMS etc)Isolate product & Optimize reaction conditions for improved yields & output. Required Candidate profile Industry- Leading pharma, CRO (Contract research Organization), Agrochemicals
Posted 1 month ago
1.0 - 4.0 years
2 - 7 Lacs
Gurugram
Work from Office
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
Posted 1 month ago
4.0 - 8.0 years
4 - 6 Lacs
Bharuch
Work from Office
Monitor progress of the reactions by using standard methods and analytical techniques (TLC, GC, HPLC, LCMS etc). isolation product and Optimize reaction conditions for improved yields and output. Scale up of R&D developed products to kg scale Required Candidate profile Ensure parallel execution of multiple reactions conducted both by self &the team Characterization &identification of compounds using UV, IR, MR, LCMS & GCMS etc
Posted 1 month ago
5.0 - 10.0 years
4 - 9 Lacs
Gurugram
Work from Office
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
Posted 1 month ago
0.0 - 2.0 years
2 - 4 Lacs
Mumbai Suburban
Work from Office
Role & responsibilities As a research associate / Assistant, the candidate must play a leading role in ongoing pilot scale testing and research projects. The candidate will be responsible for ensuring the current pilot plant is successfully scaled up. The candidate is expected to vary process parameters and optimize the manufacturing process of fabricating membranes. Conduct lab scale trials and implement them successfully on pilot plant. Responsibilities include simulating processes, getting quotes, estimating total job / project cost and preparing proposals. Keep leads and supervisor informed of project status and work progress, required project material and equipment. Prepare and maintain accurate laboratory records. Having good knowledge of testing all types of chemicals for industrial applications. Should have good experience in handling all lab equipments. Would be responsible for testing of product sampling, incoming sampling & R&D testing. Generate and maintain accurate documentations of process specification, standard operating procedures (SOPs), equipment requirement and quality control standards throughout the technology transfer lifecycle. Preferred candidate profile Should be graduate, M.Sc., B.Sc. Chemistry, BE Chemical from reputed university. Minimum 2+ years of experience in the field of research and development, technology transfer work within Speciality chemical manufacturing industries. Excellent communication and interpersonal skills with the ability of effectively collaborate with both technical and non-technical team. Female candidate preferred. Research experience from environment analysis or membrane analysis . Sound knowledge of Material science, membrane technology is plus. Should be able to work individually. Strong understanding of processing, chemical manufacturing associated with analytical technique. Recent graduates / Fresher can also apply. Immediate joiners preferred. Work location Andheri West Mumbai. Week Off Alternate Saturday are off & Sunday. Contact hr@vipulorganics.com
Posted 1 month ago
4.0 - 6.0 years
3 - 4 Lacs
Hyderabad
Work from Office
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
Posted 1 month ago
9.0 - 14.0 years
6 - 10 Lacs
Bharuch
Work from Office
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
Posted 1 month ago
2.0 - 6.0 years
3 - 4 Lacs
Navi Mumbai
Work from Office
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
Posted 1 month ago
2.0 - 5.0 years
4 - 7 Lacs
Ahmedabad, India
Work from Office
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)
Posted 1 month ago
4.0 - 8.0 years
6 - 10 Lacs
Medak, Telangana
Work from Office
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)
Posted 1 month ago
4.0 - 8.0 years
6 - 10 Lacs
Medak, Digwal
Work from Office
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)
Posted 1 month ago
4.0 - 8.0 years
3 - 7 Lacs
Medak, Digwal
Work from Office
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)
Posted 1 month ago
5.0 - 8.0 years
5 - 10 Lacs
Ahmedabad
Work from Office
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
Posted 1 month ago
4.0 - 8.0 years
3 - 7 Lacs
Medak, Telangana
Work from Office
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)
Posted 1 month ago
4.0 - 8.0 years
3 - 7 Lacs
Medak
Work from Office
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)
Posted 1 month ago
2.0 - 7.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation AR&D Department . Job Openings: 3 Nos Position : Research Analyst or Sr Research Analyst Experience : 3 - 8 Yrs Job Description: Responsible for Analytical Method Development activities solid orals and injectables Responsible for Responsible for Planning and Monitoring of Method development activities and Regular Analysis for solid orals and Injectables. Responsible for Routine and Stability analysis activities for solid orals and injectables. Responsible for the Review of documents generated in Method development activity. Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Responsible for the review of Routine samples documents, Preformulations documents for the Solid oral products and Parental products. Responsible for the Review of Calibrations documents (i.e Dissolution, HPLC, UV and balance). Knowledge on ICH guidelines and all Regulatory guidelines. Responsible for XRD - FARD Experience. Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:
Posted 1 month ago
2.0 - 4.0 years
4 - 6 Lacs
Mumbai
Work from Office
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
Posted 1 month ago
1.0 - 6.0 years
4 - 8 Lacs
Kolkata
Work from Office
Role Purpose The purpose of the role is to source and hire the right talent against the requirements shared by the business and ensuring a positive employer brand experience for the candidate throughout the hiring process. Do 1. Hire the required talent from the different sourcing channels Understand business projections and urgency of talent requirements across order and cadre demands, skill type (type A/B/C), volume vs. niche etc. As per the talent requirements shared by the business, Create sourcing plan as per hiring channel mix and cost considerations Utilize job portals, consultants, employee referral to find the right fit from the industry/ within Wipro For the shortlisted candidates, facilitate the selection process with the technical panel As per the requirement by the business, facilitate different selection tests like technical programming language skills Conduct HR evaluation round and negotiate with the candidate(s) on the salary, position etc Take necessary approval from the tower lead/ head ensuring, hiring is strictly as per Wipros salary range, minimizing exceptions to meet average cost per candidate target Formally roll out the job offer to the selected candidate(s) and coordinate with him/ her for offer acceptance Motivate, engage and maintain relationship with the selected candidate(s) from time to time till their joining Coordinate with the HRSS team for background verification of the selected candidate Communicate with Business Teams and Managers to from time to time on the status of joining etc 2. Manage Candidate Experience throughout the recruitment process Conduct candidate connect and pre-hiring candidate engagement activities to ensure healthy joining ratio Adherence to Wipro guidelines, processes and protocols with respect to responsiveness, clarity, compensation structure, SLAs, quality and auditability in all candidate communication, and deliver Zero valid escalation on hiring process Resolve candidate concerns and manage candidate escalations, turnaround slightest negative experience Daily maintain the data on the recruitment tool (Synergy) and upload all the candidate documents from time to time Ensure the weekly/ monthly/quarterly dashboards are updated and readily available for the management review Conduct meetings with WMG teams to update on the progress, risk and issues involved in hiring for a position and seek help if necessary Follow checks and balances placed by the recruitment team and conduct regular reviews with the management to ensure reliability, quality and integrity of recruitment data in the system Deliver No. Performance Parameter Measure 1. Fulfilment Targets Numbers per quarter as per plan (Fulfilment ratio, net add) Numbers per quarter as per plan (Fulfilment ratio, net add) Numbers per quarter as per plan (Fulfilment ratio, net add) 2. Average Recruitment Cost Per Person Deviation from Wipro salary range - Numbers as per plan 3. Customer Satisfaction Candidate Experience Zero escalations Hiring Manager satisfaction score As per plan 4. Cost of hiring (Cost incurred on portals, vendors etc) Deviation from Channel Mix and Budget - as per plan 5. Compliance % Deviation from Source-to-Hire policies Zero Online / Tool data reliability 100% Reinvent your world.We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.
Posted 1 month ago
5.0 - 10.0 years
5 - 8 Lacs
Hyderabad
Work from Office
Key Responsibilities: Perform analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs) as per approved specifications and SOPs. Operate and maintain analytical instruments like HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, etc. Review and verify analytical data and ensure proper documentation in line with cGMP and GLP guidelines. Prepare and standardize volumetric solutions and reagents. Carry out stability studies and maintain stability data as per ICH guidelines. Ensure timely calibration of laboratory instruments. Perform method validation/transfer activities as per regulatory and internal requirements. Involve in investigations related to OOS/OOT/Deviations and CAPA implementation. Coordinate with cross-functional departments like QA, Production, and R&D for smooth workflow. Comply with all safety protocols and maintain a clean and organized lab environment. Desired Candidate Profile: Hands-on experience in analytical techniques (HPLC/GC) is a must. Good knowledge of regulatory guidelines (ICH, WHO, USFDA, etc.) Strong documentation and communication skills. Experience in a regulated API manufacturing unit is preferred.
Posted 1 month ago
1.0 - 4.0 years
3 - 6 Lacs
Ahmedabad
Work from Office
Candidate should be exeprinecd in process development in R&D in API synthesis Candidate with the exeprience of handelling Photo reactor will be prefered . Experience in Vitamin synthesis will be prefered
Posted 1 month ago
2.0 - 7.0 years
3 - 7 Lacs
Jhagadia
Work from Office
"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. "
Posted 1 month ago
7.0 - 11.0 years
6 - 12 Lacs
Gurugram
Work from Office
Role & responsibilities 1. To undertake literature search & preparation of reports for a new development project. 2. To execute analytical method development trials as part of prototype development till technology transfer of new drug products at the manufacturing QC sites. 3. To guide & supervise development trainees or associates during analytical method / development of new formulations. 4. To prepare Master documents of Analytical Method Development / Analytical reports for submission & validation batches. 5. Material Master creation of Material code/ Vendor code in ERP of MIC creation of Analytical Raw material / Packing material / Finished products in ERP 6. To raise requisitions of analytical materials viz. Working, Impurity Standards, Columns, reagents & Solvents etc. for analytical method development requirements. 7. Involving in all Analytical Development QA activities & ensure compliance. Interested candidates can share their resume at shikha.mishra@walterbushnell.com
Posted 1 month ago
7.0 - 10.0 years
10 - 15 Lacs
Visakhapatnam
Work from Office
We are specifically opening this position to people in an Assistant Manager or Team Leader Role who think they are ready for the Next Challenge! The person filling this role should be meticulous and experienced to lead method development, validation, stability studies, and technology transfer activities at Synnat Pharma , Visakhapatnam. This role involves close collaboration with R&D, QC, and Regulatory teams, supporting product development and compliance with global pharmaceutical standards. The ideal candidate will have strong analytical expertise, leadership skills, and a commitment to regulatory compliance and continuous improvement. Responsibilities: Develop, optimize, and validate analytical methods (HPLC, GC, UV-Vis, Dissolution) as per ICH and regulatory guidelines Prepare and maintain validation protocols, analytical reports, and ensure GDP compliance Oversee method transfer to QC, provide training, and address troubleshooting Conduct stability studies and prepare data reports in alignment with regulatory expectations Collaborate with cross-functional teams (QA, QC, Packaging, Regulatory) to support product development Investigate and resolve analytical issues including OOS, OOT, and deviations; implement CAPAs Maintain up-to-date documentation and ensure compliance with GMP/GLP standards Evaluate vendors and key starting materials (KSMs); provide insights to management General Expectations and Past Experience: Strong understanding of analytical chemistry principles, techniques (HPLC, GC, Dissolution, UV-Vis) Proven experience in method development, validation, and regulatory compliance Familiarity with global pharmaceutical regulations (FDA, EMA, WHO) and ICH guidelines Hands-on experience with pharmaceutical quality systems (GMP, GLP) Skilled in handling regulatory submissions and documentation Excellent problem-solving abilities using data-driven approaches Leadership skills with experience in mentoring R&D scientists Familiarity with CAPA systems and good documentation practices
Posted 1 month ago
1.0 - 6.0 years
2 - 5 Lacs
Hyderabad
Work from Office
Role & responsibilities Primary Responsibilities: 1. Performance of Method Development, Validation and Study Sample Analysis using LC-MS/MS systems. 2. Operation, Calibrations and Maintenance of Pipettes, pH meter, Balance, HPLC, Dispensers and Turbo-Evaporators, Centrifuge, Solid-Phase Extraction, and other Bioanalytical equipment. 3.Preparation of Method Validation Protocols, Method Validation Reports, Standard Test Procedures, SOPs, and Bioanalytical Reports. 4. Responsible for documentation as per in house SOPs and practices in raw data forms and logbooks. 5. Compilation of Calibration Data, Bio analytical raw data forms and logbooks. 6. Maintenance of Workplace. 7. Reporting to supervisor/HOD about progress of the jobs assigned. 8. Follow in-house procedures for safe disposal of waste generated in the lab. 9. Recording the temperature and humidity in the lab. 10. To ensure all applicable SOPs are complied with for the work being done. 11. To ensure that raw data and other documents are recorded appropriately reflecting the actual sequence of events. 12. To ensure that all the results are being transcribed, reported, and calculated appropriately matching with chromatographic data and raw data. 13. Maintain cleanliness and safety aspects in the Lab. 14. To ensure proper labeling for all the reagents, solutions, and chemicals in the laboratory. 15. Ensure the archival of all completed study and validated documents. Secondary Responsibilities: 1. Maintenance of Columns and Reference Standards in the lab. 2. Any other responsibilities assigned by HOD. Preferred candidate profile Qualification : M.Pharmacy / MSc Chemistry Experience : 1-6 Yrs in Clinical Research - Bioanalytical
Posted 1 month ago
20.0 - 30.0 years
500 - 1000 Lacs
Hyderabad
Work from Office
Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization • You need to co-ordinate and follow up with external labs including training of their staff. • You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. • You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. • You will have to participate in handling and resolution of laboratory non-conformances with related documentation • You will be responsible for analytical methods and process compliance as per quality assurance requirement. Qualification Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 – 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills • Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies • Efficient in MS Office, Word/Excel/PowerPoint functionalities • Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. • Ability to understand analytical methods defined by global and local bodies • Ability to resolve analytical issue associated with different product matrix. • Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. • Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate • Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills • Systematic approach and strategic thinking • Possess excellent interpersonal skills, communication, coordination, and time-management skills • Ability to independently handle teams • Excellent oral/written communication and articulation skills • Passion for people development • Ability to prioritize work and change focus quickly • Ability to delegate effectively Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. 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/#!/
Posted 1 month ago
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