356 Method Validation Jobs - Page 3

You have proven experience working in GMP/GLP and scientific environments. You possess basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, as well as peptide characterization. Your expertise lies in at least one of these subjects. Additionally, you have experience in related compound method development and method validation for Peptide drug products using LC-UV and Amino acid analyzer. Hands-on experience with SEC-UV SEC-MALS, SV-AUC, CE, and data interpretation is also one of your strengths in at least one of the techniques and data interpretation. You are skilled in the preparation and review of method development and method validation reports. Knowledge of ICH guidelines and regulatory requirements for peptide products is part of your expertise. As a team player, you are willing to work at different job locations as per the team's requirement. Furthermore, having knowledge of scientific writing will be a plus. Qualifications required for this role include an M. Pharm/M. Sc degree. Amneal is an equal opportunity employer that values diversity and inclusion, ensuring no discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative people management for both current and future business needs. The team performs key roles such as: - Executive Role: Specialists in all aspects of people management, providing high-level strategic input into key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practice employment policies and procedures across the organization. - Facilitator Role: Partnering closely with different areas of the organization to support, advise, and enhance their ability to meet objectives through highly effective employment practices in areas like Talent Acquisition, Learning and Development, Reward systems, Performance Management, and Health and Wellbeing. - Consultancy Role: Providing expert advice to the organization and its managers on various aspects of workforce management, employee relations, and performance. - Service Role: Keeping the organization informed and equipped to handle developments impacting employment matters, including changes in legislation and labor market characteristics.,

Experince in HPLC & GC will be preffered Quality Control Inspection Sampling, inspection and testing of material (Analysis of material) Analytical method validation Conduct test such as Tests: GC, HPLC QC Documentation Male Candidates can apply

As a part of this role, you will be responsible for method development, method validation, and routine analysis in Orals and Non-orals Formulations. Your area of experience will include conducting the Microbial Enumeration Test, Test for specified Micro-organisms, Bio-burden Test, Antimicrobial Effectiveness Test, Sterility Test, Bacterial Endotoxin Test, Microbiological Assay, Microbial Culture propagation, maintenance, and enumeration, Growth Promotion Test, as well as Environment monitoring. In addition to the above, you will also be involved in the preparation of SOP's/STP's/Documentation, calibration of laboratory equipment/Instrument, ensuring work is conducted as per cGMP/GLP Compliance, and having exposure to LIMS. Your role is crucial in ensuring the accuracy and reliability of testing procedures and results, and your expertise in various microbiological tests will contribute significantly to the overall quality and compliance standards of the organization.,

As a valued member of our team, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your dedication to quality, coupled with our customer-oriented culture, rooted in science and compliance, will directly impact patient care. You will contribute to upholding a quality culture that evolves to meet patient needs, guaranteeing that our products meet the highest safety and efficacy standards. In this role, your responsibilities will include creating, reviewing, and approving test method transfer and validation protocols, reports, and equipment qualification records. You will maintain compliance with Good Manufacturing Practices in Quality Control and Stability laboratories, support media preparation, handle Bio ball cultures, and conduct microbiology-related investigations. Additionally, you will perform testing on various samples, manage Laboratory Information Management System builds, review laboratory data, serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and provide training to junior colleagues. To excel in this role, you must possess a Master's degree in microbiology with a minimum of 6 years of relevant experience. Strong technical skills in method validation and testing, along with experience in microbiological testing of water, are essential. A deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations, coupled with attention to detail and robust knowledge of quality systems, will be key to your success. Effective written and verbal communication, interpersonal skills, and familiarity with research unit clinical and analytical laboratory environments are also necessary. Preferred qualifications include relevant pharmaceutical experience, a strong understanding of computer system hardware, infrastructure, and networks, as well as experience with Laboratory Information Management Systems (LIMS). Proficiency in data analysis and interpretation, knowledge of regulatory requirements and guidelines, strong problem-solving abilities, effective time management, organizational skills, and the ability to mentor and train junior colleagues are considered advantageous. Your work location will be on premise, and Pfizer is proud to be an equal opportunity employer that complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates. Join us in upholding quality assurance and control to make a meaningful difference in patient care.,

You should be fluent in Application Development and have experience in developing applications for compound and biomolecule analysis. Your expertise in Mass Spectrometry will be crucial, as you will be skilled in using mass spectrometry for detection and analysis. Additionally, you should be well-versed in instrument handling and operation, understanding mass spectrometry instrumentation and its operational workflows. Proficiency in sample pre-processing techniques is required for accurate analysis, along with a strong ability in quantification and spectral data interpretation. You should also be skilled in method troubleshooting and validation, capable of identifying issues and ensuring method consistency and compliance through process and method validation. The key requirements for this role include a postgraduate or PhD in Analytical Chemistry with specialization in Mass Spec or Physics. The job location for this position is Bangalore. For more information or to apply, please contact us at career@bigtec.co.in or hr@bigtec.co.in.,

Key Accountabilities Accountability Cluster Major Activities / Tasks Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform part method validation, forced degradation studies, excipient compatibility studies, reverse engineering, add-mixture studies, in-use studies, hold-time study and analysis of routine & stability studies Conduct cleaning validation studies Perform analysis of API, excipients and secondary material (packaging material, ink, adhesive etc.) Develop cost effective & time saving analytical method for new or existing product Evaluate the pharmacopeia and verify the documents Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Maintain the lab instruments / equipment and troubleshoot the issues Perform calibration (schedule / breakdown) and calculate instrument utilisation Up-keep the HPLC/GC/IC columns as per cGLP Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Record and document all analytical activities in timely manner in Lab note-book, instrument/equipment and column log book Provide base documents for MOA / COA preparation for better coordination in analytical studies Provide support to units or CFTs for transfer of analytical methods and techniques by visiting and demonstrating them with the relevant analysis to ensure successful and timely transfer of products Transfer methods and technologies to other units and departments Study the literature to resolve units and regulatory queries and conduct investigation studies in stipulated time period Analyse samples at pilot plant and unit for trace determination (Cleaning Validation) Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents Follow safety guidelines by ensuring use of PPE & MSDS of chemicals at time of analysis Upkeep the samples given for analysis and ensure timely destruction after analysis as per SOP Dispose solvents and waste generated during the analysis Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations Arrange analytical requirements like column, impurities, standards, placebo and samples for units and other department like Validation Lab or Outsourced Lab Review and recommend corrections in the MOA, COA & Specifications Major Challenges Delay in developing analytical method due to unavailability of HPLC/ GC columns, reference impurities and specific instruments. Overcome by prior planning and by using alternate resources Additional or rework due to frequent changes in project priorities. Overcome by proper planning Key Interactions Internal External Formulation R&D for improving the quality of product (Daily) Loan Licence Team for analytical requirements which has to be provided (Weekly) Units for execution of project in unit (Twice a week) CRO for outsource analysis, validation, verification, release etc. (Twice a week) Service Engineers for breakdown of equipment and instruments (Fortnightly) Dimensions Average number of projects : 8 (FY2016-17) Average number of analytical method developed : 10 (FY2015-16) Average number of part method validation : 7 (FY2015-16) Average number of method transfers / unit queries : 2 Average number of additional projects: 4 (e.g. CIP, CHC, POC, etc.) Average number of Tec Mar studies completed : 10 per year Average number of new monographs evaluated : 10 per year Key Decisions: Decisions Recommendations Finalisation of analytical method or any change in existing method to Group/Sub-Group Leader - Formulation ADL Comments: Skills & Knowledge Educational qualifications: M. Sc. (Analytical Chemistry) / M. Pharm. Relevant experience: 2-4 years of experience in pharmaceutical organisation with knowledge of handling instruments like HPLC, GC, Dissolution tester and DPI related instruments Knowledge of current guidelines like ICH, EMEA, WHO

Summary 400! This is the number of associates in Global Analytical R&D, across 4 countries, working tirelessly on innovative and patient centric medicines. As part of this group, you design, plan and/or perform scientific/technical studies. By bridging the analytical science to the clinical performance, you will drive the transformation of our molecules into medicines that improve and extend patient s lives. The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD). About the Role Major accountabilities: Design, plan and interpret scientific experiments for projects at different clinical phases of drug substance and drug product development with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports. Provide scientific guidance to the laboratory associates Write, review and/or approve analytical documentation in timely and high-quality manner, such as releases, analytical batch records, method validations, stability, technical reports, SOP s etc. ensuring compliance with Novartis and health authorities guidelines Helping to define the overall analytical control strategy Contribution to scientific exchange groups within Novartis Report and present scientific/technical results internally and contribute to publications, presentations, and patents Manage interactions and contribute to a high level of collaboration with internal and external stakeholders. Adhere to Quality metrics, Compliance and Good Documentation Practices following ALCOA+ principles, GLP, OQM, HSE, ISEC and Novartis guidelines. Should be a Team player by adding value in collaborating with other teams to support project deliverables within agreed timelines, mentoring new joiners, active participation in project meetings / networks / meetings and contributing to team goals while meeting individual objectives. Ability to perform investigations, guide team members, communicate proactively and clearly to global stakeholders and handle multiple priorities. Provide input into CMC documents to support regulatory submission and respond to HA queries. Role Requirements PhD in analytical chemistry or equivalent and a minimum 6 years experience or M. Pharma/M. Sc with a minimum of 12 years experience in the pharmaceutical industry in analytical research and development Experience in leading analytical activities in NCE across different phases of drug development, including complex injectables, parenteral, oligonucleotides/ peptides. Strong experience in various chromatography techniques is a pre-requisite. Experience in mass spectrometry applied to biological molecules would be an asset Profound expertise in liquid chromatography separation techniques such as (RP, IEX and HILIC) is a must Experience in Late phase method validation is an asset Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc. GMP experience in analytical laboratory Successfully demonstrated expertise in a specific scientific/technical area Good presentation skills and scientific/technical writing skills. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Walk In Drive For Quality Control Department In Formulation Division @ Burgula Department :- Quality Control Qualification :- BSC | B Pharmacy | MSC | M Pharmacy Experience :- 5 to 6 Years Interview Date:- 30-07-2025 Interview Time:- 9AM TO 2.00PM Work Location: - MSNF-VI,Burgula Venue Address:- X59Q+P95, Mothighanapur, Burgula, Telangana 509202 Note:- Candidate should bring Update Resume , Offer Letter, Increment Letter,CTC,Payslips ,Bank Statement, Certificates,Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Business - Research & Development Department - ADL ( API ) Position - Research associate to Team Lead Qualification - M.Sc./M.Pharm Experience - 3 to 8 Years Contact - Sharad Yadav ( HR ) - sharad.yadav@cadilapharma.com

Job Summary We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards. Roles & Responsibilities You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods. You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples. You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities. You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development. You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department. You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed. You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour. You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency. You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions. You will be responsible to evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process. You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements. You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualification Educational qualification: Masters in Science/ Organic chemistry Minimum work experience: 4 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Active Pharmaceutical Ingredients. Experience in Process Optimization (Manufacturing) Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. 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/#!/

As a Micro Lead API at our Ahmednagar location in the grade of G9B- Sr. Manager 2, your primary responsibility will be to plan, review, and monitor all activities within the Microbiology department. You will lead the department, ensuring smooth coordination with other departments to prioritize tasks and provide timely support and testing to prevent delays in analysis. Your role will involve reviewing all departmental documents and results in the LIMS system specifically in the microbiology section. You will oversee the lysate sensitivity test, Bacterial endotoxin test of WFI and API products, as well as validate the bacterial endotoxin test and microbial quality of products. Additionally, you will be responsible for the procurement, receipt, storage, maintenance, and reconciliation of biological indicators, media, reagents, standard cultures, and bioball. Calibration and operation of the TOC analyzer, environmental monitoring activities, qualification, and calibration of all instruments in the microbiology laboratory will also fall under your purview. Participating in investigations, reviewing deviations/OOS/OOT/OOC/Lab Event, and SOP revisions in the micro section online are crucial aspects of your role. You will need to maintain logbooks, prepare and review GMP documents, ensure fumigation activities, and review trends for water and environmental monitoring. Adherence to online good documentation practices, validation of autoclave, Dry heat sterilizer (DHS), Incubators, Laminar Air flow, HVAC, preparation of reagents, inventory, and stock record maintenance, GLP compliance, and safety protocols are essential responsibilities. Furthermore, you will be expected to support review and compliance activities in the quality function, coordinate with corporate functions regarding microbiology activities, and follow any other responsibilities assigned by the Quality head. Graduates in Microbiology or equivalent with experience in Micro testing/leading are encouraged to apply.,

As an Analytical Technical Writer, your main responsibility will be to prepare and review analytical technical documents based on laboratory data. This includes but is not limited to product specifications, analytical test methods, validation protocols, reports, stability study protocols, and reports. You will also be required to collaborate with client stakeholders and external laboratories to gather necessary documentation. Additionally, you will be responsible for managing change control processes in coordination with cross-functional teams and ensuring timely implementation of changes. Your role will involve reading analytical laboratory data and transforming it into a report format. It is essential to have experience in verifying the completeness and accuracy of technical reports, as well as managing the lifecycle of technical documents. You will support cross-functional teams by providing technical documents for submission requirements and adhere to client documentation standards and best practices. To be successful in this role, you should hold a minimum of M. Sc. in Chemistry, M. Pharmacy, or a related scientific field. A minimum of 2-4 years of experience in Quality Control, QA documentation, R&D, or Analytical Quality Assurance is required, along with strong analytical thinking skills. If you are passionate about analytical writing and possess the necessary qualifications and skills, we invite you to join our team as an Analytical Technical Writer in Mumbai on a full-time basis.,

We are looking for a highly skilled and experienced Analyst-QC to join our team at eClerx Services Ltd. The ideal candidate will have a strong background in IT Services & Consulting, with excellent analytical and quality control skills. Roles and Responsibility Collaborate with cross-functional teams to identify and prioritize testing requirements. Develop and implement comprehensive test plans and cases to ensure high-quality deliverables. Conduct thorough analysis of test results and identify areas for improvement. Work closely with the development team to resolve defects and enhance overall product quality. Participate in continuous improvement initiatives to optimize testing processes. Maintain accurate records of test cases, results, and defect reports. Job Requirements Strong understanding of software testing principles, methodologies, and tools. Excellent analytical, problem-solving, and communication skills. Ability to work effectively in a fast-paced environment and meet deadlines. Experience with quality control processes and procedures. Familiarity with industry standards and best practices for software testing. Strong attention to detail and ability to identify defects and errors.

You get to collaborate on: Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE.

Job Summary Job Title Research Associate I Location Whitefield, Bangalore Shift General Essential Duties and Responsibilities: Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines. Make sound technical recommendations in routine analytical activities. Provide analysis/redesign of key experimental procedures. Produce scientific experimental data based on written procedures like method of analysis, protocols etc. Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc Provide input to select analytical techniques and procedures to solve problems within area of responsibility. Apply technical theories and principles to projects within area of expertise. Independently analyze and propose solutions to research challenges. Learn newer analytical techniques to enhance the capability and productivity. Author documents like Method of analysis/ protocols/ reports Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory. Participate and take ownership of equipment installation and qualification activities as per QMS. Document laboratory work performed pers GDP. Work according to appropriate quality standards and quality principle (e.g., Data Integrity, ALCOA) Follow Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement. Qualifications: Hands-on experience in chromatographic and/ or spectral techniques like LC-MS/MS, GC-MS, and/or ICP-MS/ ICP-OES. Operation of analytical tools/ instruments (weighing balances, pH meters etc.) and wet chemistry sample preparation techniques. Should have analytical problem-solving skills, high learning agility, innovative experimental attitude along with good presentation skills. Excellent written and verbal communication skills in English. Demonstrates an inclusive attitude and an ability to collaborate with team members and cross-functional team members for project deliverables. Ability to objectively assess, organize, and clearly communicate information. Ability to interpret available information and make recommendations to resolve technical challenges. Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner. Provide and accept critical feedback from others in a constructive manner. Adapt to changes and have an agile mindset. Embrace diversity and inclusion, value differences. Education and/or Experience: Educational Qualification: Postgraduate/ Ph. D. in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ Ph. D.) Professional Experience: 3 to 6 years of relevant experience

Conduct NPD, process optimization, scale-up & value engineering. Develop synthetic routes, validate methods, identify raw material alternatives. Maintain documentation. Support validation & transfers. Coordinate with QA, QC & production.

Hiring - ADL (AMD) - Nagpur Location Location - Nagpur MH Company - Pharma (MNC) Core OSD Formulation + Method Validation Experience Msc or Mpharm /bpharma Responsibility - Sr. Role Description 1. Analytical Method Development New analytical method development and troubleshooting of existing method of different types of Oral solids dosage form (Granules, Tablets, Pellets, Capsules etc.) for Regulated market projects or as per business need. 1. Ensure robust & cost effective method development of product by considering the available facility & resources 2. Conduct Literature survey, different pharmacopoeia & pharmacopeia forum search and review & application of same in AMD. 3. Conduct Pre-formulation studies (API characterization and Drug-Excipients compatibility studies). 4. Operation and calibration of different analytical instruments. 5. Take into account existing QC facility while developing any product for successful method transfer. 6. Analytical method validation and method transfer activity. 7. Maintain the Good Laboratory practices, Good Documentation practice and Good hygiene practices. 8. Prepare for all type of internal and external audit/inspection. 2. Stability Studies of R&D Products 1. Responsible for stability studies of new R & D products for Regulated market projects. 2. Responsible for interpretation of stability data of the products related to analytical methods. 3. Observations of stability trend and discussion of same with formulation team. 4. Management of stability batches analysis and take the decision for stability studies of different batches as per requirement. 3. Routine Support to F&D Team 1. Responsible for providing routine support for the new product development for regulated market projects. 2. Planning and execution of routine batches analysis in minimum possible time. 3. Analytical data review and to provide the online results and observations to F&D Team. 4. GLP, GDP and Documentation Support 1. Responsible for maintaining the overall GLP and GDP in the Laboratory and providing overall GLP support during day to day activities. 2. Maintenance of working standards, Impurities and reference standards 3. Responsible for preparation, review and approvals of all the documents generating in the ARDL laboratory. 5. Team Building 1. Ensure continuous training and up-gradation of knowledge of the R&D team so that they are at the cutting edge of technology. 2. Set challenging goals for team members to ensure they deliver as per their true potential & as per the need of organization. 3. Identify & nurture the top talent of team. 4. Arrange a monthly interaction with team members to understand & resolve their performance bottle necks & also give them feedback for course correction. Performing any other responsibility as per the requirement, in the larger interest of organization. Interested!!!Please share your cv at Neetij@selectsourceintl.com Thanks & Regards

Must Abide by the rules & regulations of the laboratory. Responsible for Performing tests as per authorization and ensuring the TAT Compliance. Ensure Safe Handling of Equipment’s. Filling all logbooks for the equipment’s as per usage Ensure to wear all the PPE’s and lap aprons before performing the tests without fail. Ensure to follow safety rules & Maintain 5S. Pesticides & Mycotoxins analysis in food & agriculture as per authorization. Follow ISO 17025 requirements in lab with respect to Quality compliance and other regulatory requirements. Internal calibration of equipment’s Maintenance. Handling, Operating & Calibration, Maintenance of LC MSMS. Handling, Operating & Calibration, Maintenance of GC MSMS. CRM Management, Preparation, Storage, Disposal and Record maintenance. Roles and Responsibilities • Must Abide by the rules & regulations of the laboratory. • Responsible for Performing tests as per authorization and ensuring the TAT Compliance. • Ensure Safe Handling of Equipment’s. • Filling all logbooks for the equipment’s as per usage • Ensure to wear all the PPE’s and lap aprons before performing the tests without fail. • Ensure to follow safety rules & Maintain 5S. • Pesticides & Mycotoxins analysis in food & agriculture as per authorization. • Follow ISO 17025 requirements in lab with respect to Quality compliance and other regulatory requirements. • Internal calibration of equipment’s Maintenance. • Handling, Operating & Calibration, Maintenance of LC MSMS. • Handling, Operating & Calibration, Maintenance of GC MSMS. • CRM Management, Preparation, Storage, Disposal and Record maintenance.

1. Supervise end to end operations of food Chemical lab maintain the TAT for all the samples. 2. Implementation of Quality System as per all applicable accreditations like ISO 17025, FSSAI, EIC, APEDA etc. 3. Maintain all relevant documentation and presents as needed for quality audits and Regulatory audits 4. Implementation and Complying to the other TUV SUD Process and Policies 5. Implementation of good laboratory practices 6. Ensure on time method development / verification and validation 7. Implementation of any new process as decided by the management 8. Monitoring the turnaround time of the sections / reports as per the given schedule 9. Testing capability confirmation to sales and co-ordination with sales team for smooth lab operation. 10. Immediate response to internal or external enquiries. 11. Implementation of the safety guidelines for the respective areas 12. Minimize wastages inside the laboratory 13. Support in data inputs for new investment planning 14. Regular employee engagement 15. Driving continual improvements projects 16. Monitoring Expenses and take the required actions as on required 17. Coordinate and ensure Calibration / Preventive Maintenance / repair schedule with adequate documentation. 18. Equipment /method troubleshooting / repairs 19. Shift management and leave Management of the lab team 20. Supporting technical manager for RCA and CAPA 21. Ensure on-time training of respective team as per training planner Roles and Responsibilities 1. Supervise end to end operations of food Chemical lab maintain the TAT for all the samples. 2. Implementation of Quality System as per all applicable accreditations like ISO 17025, FSSAI, EIC, APEDA etc. 3. Maintain all relevant documentation and presents as needed for quality audits and Regulatory audits 4. Implementation and Complying to the other TUV SUD Process and Policies 5. Implementation of good laboratory practices 6. Ensure on time method development / verification and validation 7. Implementation of any new process as decided by the management 8. Monitoring the turnaround time of the sections / reports as per the given schedule 9. Testing capability confirmation to sales and co-ordination with sales team for smooth lab operation. 10. Immediate response to internal or external enquiries. 11. Implementation of the safety guidelines for the respective areas 12. Minimize wastages inside the laboratory 13. Support in data inputs for new investment planning 14. Regular employee engagement 15. Driving continual improvements projects 16. Monitoring Expenses and take the required actions as on required 17. Coordinate and ensure Calibration / Preventive Maintenance / repair schedule with adequate documentation. 18. Equipment /method troubleshooting / repairs 19. Shift management and leave Management of the lab team 20. Supporting technical manager for RCA and CAPA 21. Ensure on-time training of respective team as per training planner

Job Title: Invitro BA Scientist Job Location: Bangalore, Hyderabad' About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines • Overall adherence to safe practices and procedures of oneself and the teams aligned • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self • Compliance to Syngene s quality standards at all times • Hold self and their teams accountable for the achievement of safety goals • Govern and Review safety metrics from time to time Core Purpose of the Role : • To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment • Processing of different matrices samples of PK studies • Optimization of test compounds manually as well as automated on LCMS/MS • Develop methods with the team lead • Independently handling of HPLC for UV based samples analysis. • Documenting the lab note books online and compound management Syngene Values All employees will consistently demonstrate alignment with our core values ' Excellence Integrity Professionalism Experience 3- 10+years Education : Msc/Pharm/Mtech/Phd/ Fresh phd with relevant exp during academics or any postdoc Skills and Capabilities • Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory • Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods • Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis • Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required • Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra • Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff • General understanding of Drug metabolism and Pharmacokinetics • Should be able to deliver scientific presentation in departmental journal club and write official Project reports

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 25-07-2025. Requirement for Executive - FAR&D - Formulation Analytical Research & Development(FAR&D) Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting. Write cGMP Quality documents including Standard Operating Procedures, laboratory equipment procedures and investigational protocols. Excellent, enthusiastic, clear communication skills, both written and verbal, with a diverse audience are critical to the success of this position. Proven ability to interact with cross - functional and cross - cultural teams. Previous experience of running analytical techniques such as HPLC, Dissolution, KF, IC with the ability to extract and prep various samples in a variety of forms. As this role involves liaising with other departments on a regular basis, you will need good communication skills and the ability to work effectively as part of a team. Note : Formulation Quality Control Candidates also eligible. Interview Date : 25-07-2025 Department : Formulation Analytical Research & Development(FAR&D) Experience : 1 to 6 Years Qualification : M. Pharmacy / M.Sc. / B Pharm Position: Executive Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue Details MSN Laboratories, R&D Center,Pashamylaram, Hyderabad

Conduct quality control tests on API samples using various analytical techniques such as HPLC, GC, UV, etc. Method Verification, Calibration

Should be capable of handling instrument like HPLC, GC , UV, IR and potentiometry Should have the GMP knowledge and compliance requirement of QC Should have the knowledge on Good laboratory practices .

Role & responsibilities Required for Quality Control(Formulations) Quality Control(QC)- Need 1 to 5 years of experience. *Analysis of Finished Product & Stability *GLP and LIMS, Documentation Preferred candidate profile Perks and benefits

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).