460 Glp Jobs - Page 10

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

Job Title: Analytical Scientist - Phy-Chem Studies (Agrochemical & Pharma) Company Name: Vivo Biotech Ltd Location: Hyderabad Experience: 3+ Years CTC: 3Lpa - 5.5Lpa Job Description: We are seeking a detail-oriented and skilled Analytical Scientist with hands-on experience in conducting Phy-Chem and validation studies for agrochemicals and pharmaceutical compounds. The ideal candidate will have strong knowledge of global regulatory guidelines and be capable of preparing study-related documentation while maintaining audit readiness at all times. Key Responsibilities: Conduct Physico-Chemical studies for agrochemical compounds in accordance with regulatory requirements. Perform method validation studies for agrochemical products as per SANTEE/SANCO guidelines. Execute validation studies for pharmaceutical compounds as per ICH guidelines. Carry out dose formulation analysis to support toxicological and regulatory studies. Prepare and maintain Standard Operating Procedures (SOPs) for newly initiated studies. Develop study plans and compile final study reports as per relevant regulatory guidelines. Ensure all studies are conducted in compliance with GLP, OECD, OPPTS, CIPAC, SANCO, and SANTEE guidelines. Maintain effective communication with Quality Assurance (QA) personnel throughout the study lifecycle. Utilize Microsoft Excel for accurate calculations, data analysis, and result interpretation. Remain audit-ready at all times for sponsor audits, NGCMA inspections, or other regulatory reviews. Desired Candidate Profile: Strong understanding of regulatory frameworks applicable to agrochemical and pharmaceutical studies. Prior experience working in a GLP-compliant environment. Excellent documentation and report writing skills. Detail-oriented with good communication and coordination skills. Flexible and proactive approach, especially regarding audit preparedness. Thanks & Regards G NagaSravani - HR nagasravani.g@virinchi.com

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1 5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification Sc Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

Maintain the Laboratorys Quality System. , Perform analytical tests in the laboratory, Assist with laboratory administrative duties, Maintain smooth laboratory work flow, Obtain lab certifications and complete QA/QC assignments, Promote good customer relations with all clients. Sample collections , Analytical and problem solving abilities as well as team building ability, Strong and efficient verbal and written communication skills, Ability to adapt and drive change, Experience with ISO standards; ASTM and/or DIN standards Must have strong Knowledge of ISO 17025:2017 & Must have implemented the same in any Lab. Knowledge of GC, HPLC shall be an added advantage. Candidate must be well conversant with MoU Qualification- Graduate with Training of ISO 17025:2017

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreements with external partners Risk assessments and periodic performance reviews of critical vendors Handling of audit observations and CAPA follow-up Supporting change control and deviation management related to vendors Qualifications B.Pharm / M.Pharm / M.Sc. in a relevant discipline 5-8 years of relevant experience in Quality Assurance, specifically in Vendor Management Sound knowledge of GMP regulations (USFDA, EU, MHRA, etc.) Experience in vendor audits and supplier qualification Strong documentation, communication, and interpersonal skills Proficiency in QMS tools and audit management systems

Core Purpose of the Role: As a Study Director - Toxicology: Responsible for ensuring that GLP toxicology studies; acute, repeat dose and reproduction are carried out to the required scientific and regulatory standards as per Global regulatory guidelines [ICH/OECD]. Function as single point of study control, overall responsibility for the scientific, technical and regulatory conduct of studies, scientific interpretation, documentation and reporting of results. Role Accountabilities: Study Director for in vivo toxicology studies Coordination with local cross-functional teams like veterinary science, biopharmaceutics, bioanalysis, pharmacokinetics or in vitro biology before, during and after execution of toxicology studies Conduct of in-life phases of toxicology studies in rats, mice and rabbits Dose administration in rats, mice and rabbits with various routes of administration Use of on-line data capture system- Pristima Blood sample collection for toxicokinetic Assistance during necropsy activities such as organ weighing, data entry in PROVANTIS software Assistance in conducting rabbit electrophysiology studies Coordination with veterinary science team IAEC meetings- preparation and maintenance of FORM-B and FORM-D Blood collection in rats and mice via different routes for clinical pathology analyses Preparation and following of in-house SOPs Co-ordination for preventive maintenance and calibration of instruments. Archival of materials from toxicology studies. Any other duties given from time to time by the line manager

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)

Maintain the Laboratory's Quality System. , Perform analytical tests in the laboratory, Assist with laboratory administrative duties, Maintain smooth laboratory work flow, Obtain lab certifications and complete QA/QC assignments, Promote good customer Must have strong Knowledge ISO & Must have implemented the same in any Lab. Knowledge of GC, HPLC shall be an added advantage.

: - Excellent knowledge of products Manufacturing of Colour Cosmetics personal care, Skincare, Cream, Shampoo, Hair Oil, Conditioner, Face Wash, Body Wash, Body Lotion and Foot Care ,Lipstick, Nail Polish Etc. Lay down procedure to implement GMP & GLP norms and ensure documentation & compliance Define AQL for incoming raw material and components Develop vendor base to meet cost, quality (manufacturing and product), and innovation requirements Development of new formulation as per the business demand Preparation of documents & Registration of product, label compliance with regulatory authorities - local & overseas. Skills :- Must come from the personal care background. Worked for the majority of their career in the development of formulations for personal care products. Familiar with cosmetics compliance requirements for EU, US FDA. Ready and able to work on multiple product formulations at the same time, with a view to develop potentially new products.

Job Title: Section Head (Toxicology)Location: Bangalore Industry: Pre-clinical Contract Research Organization Job Type: Full-time About the Role: We're seeking an experienced Section Head to lead our toxicology team, combining scientific expertise with strategic oversight. This dual-role position demands strong leadership, regulatory knowledge, and cross-functional collaboration to support drug development from discovery to late-stage clinical trials. Key Responsibilities: Design and manage toxicology studies. Mentor teams and shape toxicology strategy across programs. Collaborate with cross-functional teams to support drug development. Requirements: Experience: 12-15 years of relevant experience in toxicology or a related field. Education: Ph.D. or Master's degree in Veterinary Sciences or Biosciences. Desirable Certifications: DABT Certification and FELASA certification. Skills: Expertise in acute and repeat-dose toxicity studies. Strong understanding of pharmaceutical R&D and agrochemical testing processes. Proven cross-functional team collaboration. In-depth knowledge of GLP and global regulatory guidelines. Excellent scientific writing and communication skills. Strong team leadership and project management skills. High proficiency in data analysis and interpretation. Behavioral Competencies: Excellent communication and adaptability. Effective time management. Proven mentoring and team leadership. Experience integrating toxicology insights into clinical development. Ability to manage complex studies and cross-functional teams. What We Offer: Opportunity to lead in a dynamic CRO environment. Collaborative team. Growth opportunities. If you're a seasoned professional with expertise in toxicology and leadership, apply now with your resume. How to Apply: Email: Sekhar.Sompalli@advinus.eurofinsasia.com We look forward to hearing from you!

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)

Job Title: Principal Scientist - (Study Director in Toxicology) Location: Bangalore Industry: Pre-clinical Contract Research Organization Job Type: Full-time About the Role: We are seeking an experienced Principal Scientist to lead our toxicology studies, designing, conducting, and reporting non-clinical safety studies (GLP and non-GLP) in support of drug development and regulatory submissions. This role demands strong scientific leadership, regulatory expertise, and cross-functional collaboration. Key Responsibilities: Design, conduct, and report non-clinical safety studies (GLP and non-GLP) for drug development and regulatory submissions. Provide scientific leadership and ensure regulatory compliance in toxicology studies. Collaborate with cross-functional teams to ensure study integrity and success. Requirements: Experience: 8-10 years of relevant experience in toxicology or a related field. Education: Ph.D. or Master's degree in Veterinary Sciences or Biosciences. Desirable Certifications: DABT Certification and FELASA certification. Skills: Expertise in repeat dose toxicity, teratology, and reproductive toxicity experimentation. Strong understanding of pharmaceutical R&D and agrochemical testing processes. Excellent team working and leadership skills. In-depth knowledge of GLP and regulatory guidelines. Strong scientific writing and communication skills. Ability to manage multiple projects and lead teams. Proficiency in data analysis and interpretation. Behavioral Competencies: Excellent communication and adaptability. Effective time management. Continuous learning and improvement. Structured work approach. What We Offer: Opportunity to work in a dynamic CRO environment. Collaborative team. Growth opportunities. If you are a motivated professional looking to lead in toxicology, apply now with your resume. How to Apply: Email: Sekhar.Sompalli@advinus.eurofinsasia.com

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Job Summary: The R&D Chemist is responsible for conducting research, developing new chemical products, and improving existing formulations. This role involves working in a laboratory setting, performing experiments, analyzing data, and ensuring that products meet the required quality, safety, and performance standards. The R&D Chemist will collaborate with cross-functional teams to drive innovation and support the companys product development initiatives. Key Responsibilities: Research & Development: Conduct experiments to develop new chemical products or improve existing formulations. Perform research on the properties, composition, and reactions of substances to develop new processes or materials. Develop formulations for chemical products, ensuring that they meet performance, quality, and safety standards. Innovate new product ideas and applications based on market trends, customer needs, and emerging technologies. Analyze experimental data, interpret results, and make recommendations for further research or product optimization. Laboratory Work: Perform laboratory experiments using chemical techniques, including synthesis, purification, and characterization of chemical compounds. Maintain accurate records of experimental procedures, results, and observations in laboratory notebooks. Operate and maintain laboratory equipment, ensuring accurate and reliable results. Ensure that all laboratory work complies with safety regulations and standard operating procedures (SOPs). Product Testing & Analysis: Conduct tests to evaluate the performance, stability, and safety of chemical products. Use analytical techniques such as chromatography, spectroscopy, and titration to measure the chemical properties of substances. Interpret test results and adjust formulations to optimize product performance or resolve issues. Work closely with quality control and production teams to ensure that products meet required standards before commercialization. Collaboration & Cross-functional Support: Collaborate with the production, quality assurance, and regulatory teams to ensure that new formulations are scalable for manufacturing. Support the technical sales team by providing expertise on the chemical properties and applications of products. Liaise with suppliers and external research institutions to source materials or gather information for product development. Documentation & Reporting: Prepare detailed reports on research findings, product development progress, and experimental results. Document all research and development activities, ensuring that accurate records are maintained for regulatory and patent purposes. Present research findings and new product ideas to senior management and other departments. Assist in preparing technical documentation for new product launches or regulatory submissions. Regulatory Compliance & Safety: Ensure that all R&D activities comply with relevant regulatory standards and industry guidelines. Follow proper safety protocols in the laboratory, ensuring safe handling, storage, and disposal of chemicals. Stay up-to-date with changes in chemical regulations and industry trends to ensure that products are compliant. Continuous Improvement & Innovation: Stay informed about advancements in chemical research, materials science, and industry technologies. Participate in training and development programs to enhance knowledge of new methods, tools, and techniques. Propose new ideas and improvements for products, processes, and materials to keep the company at the forefront of innovation. Qualifications: Bachelors degree in Chemistry, Chemical Engineering, or a related field. 3+ years of experience in an R&D or laboratory environment, preferably in the chemical, pharmaceutical, or materials industries. Strong knowledge of chemical synthesis, formulations, and analytical methods. Experience with laboratory techniques such as chromatography, spectroscopy, and titration. Excellent problem-solving skills and attention to detail. Proficiency in using laboratory equipment and software for data analysis. Ability to work independently and as part of a team in a dynamic, fast-paced environment. Preferred Qualifications: Masters degree or PhD in Chemistry or related discipline. Experience in product development in industries such as coatings, adhesives, polymers, or specialty chemicals. Familiarity with regulatory standards (e.g., REACH, OSHA, GHS) and industry-specific guidelines. Knowledge of Good Laboratory Practices (GLP) and ISO standards. Strong project management and communication skills.

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)

Role & responsibilities Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant molecules. Responsible for Media & Feed formulation & preparation, components role verification & utilization based on spent media analysis for overall process improvement Responsible for Process scale up & scale down operation at various scales of Bioreactors. Responsible for analysing scientific research data using statistical software to analyse trends and patterns to help interpretation & establish the robust process. To carry out day-to-day Cell culture works with minimal guidance, sample preparation, productive coordination with cell culture and analytical groups for completion of assigned work. Maintain records and complete documentation of all the performed experiments. Compiling and interpreting experimental data of experiments in an efficient and timely manner. Visiting manufacturing facility for carrying out various R&D & process validation batches in co-ordination with Production team. Preparing SOPs, Qualification documents, AMCs, Maintaining Logbooks & LNBs. CMC data package, URS, Qualifications, Process development report, BMR & implementation of Quality system. Preferred candidate profile Must have experience in Upstream Process Development Must have experience of working on Bioreactors Must have experience in Mammalian cell culture Good knowledge and understanding of proteins. Sound knowledge on Good Laboratory Practices (GLP). Hands-on experience on protein purification technique.

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)

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)

Role & responsibilities 1.HPLC,UPLC and GC analysis of raw material, intermediate, finish product, stability sample, equipment cleaning and distilled solvent, Analytical Method development and validation 2.HPLC,GC, UPLC calibration HPLC and GC Analysis of all in-process,Intermediate, Finish Product,Stabiltity Analysis Equipment cleaning, Distilled Solvent and Raw materials. If required then sampling of finished product. Working Standard Qualification. Calibration of HPLC and GC. GCHS. R&D Analytical Metliod Development of new molecule. Analytical Method Validation. lnstnmrent Troubleshooting

Summary 6-to-8-year HVAC and Clean room design experience in Pharma, Biopharma, API facilities, well conversant with global standards for HVAC as well as Pharmaceuticals to implement in HVAC design like ASHRAE, SMACNA, ISO, ISPE, GMP, GLP, UKMHRA etc. BMS -EMS knowledge will be added advantage. Environment Sustainability knowledge. About the Role Key Responsibilities: Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc. ) to ensure appropriate execution of service deliverables Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc. ) and perform follow-up actions if required Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures. Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers. Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes. Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable. Essential Requirements: HVAC Engineer 5+ years of career span in Design, Installation and Validation of Centralizing Air conditioning & ventilation system in Pharmaceutical/Biotech Industry globally. Leadership experience for the management of internal and external resources Sound knowledge in all aspects (cost, schedule, quality) of project controlling and reporting with special focus on trend analysis and forecasting Solid analytical / data interpretation skills Sound computer skills (MS office, MS project, SAP, PM-Tools) Desirable Requirements: Degree in engineering or equivalent with specialization in HVAC design & controls Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Req ID: 329333 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Trakwise support to join our team in NOIDA, Uttar Pradesh (IN-UP), India (IN). Trakwise support resource Trackwise Support for onprimse and Digital version of trackwise for a lifesciences client. Need overall 4/ 5 yrs experience in supporting Trakwise both the on-prime and Digital versions. Work indepndently on the support issues, including admin activities and enhacements that are asigned. Minimum 4-5 years of administering and supporting applications/solutions. Strong understanding of drug discovery or related life science industry experience is required . Experience with scheduling systems is a plus. Data visualization, workflows and reporting tools (Salesforce Dataloader, flows, admin module) Strong knowledge in GLP process and GXP process Communciate with US/ UK based client based teams. Good communciation. Work in 3pm to 12am(Midnight) shift

Qualification:- M.Sc. (Chemistry)/ B. Pharma/ M.Pharma Experience:- 2-7 Years in API plant (HPLC/ GC/ LCMS/ HPI / method valication knowledge must)

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view. Randomly review of standard, column and chemical management logbooks. Ensure in-house compliance system. Randomly review of QMS activities (i.e. change control, incident, deviation). Maintain hygienic condition in laboratory. Follow GxP (GMP, GDP, GLP) for all processes. Ensuring proper use of Personal Protective Equipment. Thorough review of IQ/OQ and PQ of instrument/equipment. Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP. Perform internal audit of AD and provide appropriate training to AD team. Accompany the internal audit and provide appropriate response to audit observations. Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance. Tracking and monitoring of calibration planner and preventive maintenance planner. Responsibilities Qualifications M. Pharm/ M.Sc. Chemistry