299 Method Validation Jobs

Qualification Required And Experience Qualification - MSC (Microbiology & Biotechnology) Exp - 3 to 5 Years Primary Responsibilities P lan for sampling & testing of raw materials, finished products, in-process samples, swabs, air and water, stability samples as per the given QC plans and customer specifications for microbiological testing and monitoring Sampling and Environmental monitoring Analysis and reporting (including SAP entry and COA) Trending, Investigation and CAPA for microbiological failures Surveillance for microbiology compliance Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation) GLP and documentation, laboratory facility maintenance Release of raw material (in absence of QC Head) Preparation of Microbial SOPs and STPs Participate in various quality improvement programs and organizational initiatives Isolation and identification of isolates and maintenance of standard culture Key Result Areas Perform complete Microbiological testing Lay down systems and practices for ensuring FTR, microbiological quality of products In order to ensure production and delivery of microbial compliant capsules Key Interfaces Timely completion and reporting of all Microbiological testing to enhance smooth production activity No external failures for microbiology No non-compliance in internal and external audits Improvement in microbiology trends Show more Show less

The ideal candidate for this position will have a mission to make good health more affordable and accessible, helping millions around the world enjoy healthier lives. Working with the leading manufacturer of generic medicines, you will be a part of a team that produces products listed on the World Health Organizations Essential Medicines List. With at least 200 million people worldwide taking our medicines daily, we are continuously striving to make a positive impact and are looking for individuals to join us in this mission. Your responsibilities will include conducting Microbiological testing on various products, such as in-process, finished products, pre-formulation study samples, and stability samples. You will review analytical results, develop and validate Microbial methods, and manage laboratory resources efficiently. In addition, you will be responsible for calibration and maintenance of analytical instruments, ensuring compliance with regulatory requirements, and maintaining safe practices in the work environment. To be successful in this role, you should have an M.Sc. in Microbiology or Biotechnology, with at least 6 to 10 years of experience in a pharmaceutical company. You should possess FDA approval in Microbiology, be familiar with regulated markets (US/EU/Canada), and have a strong understanding of Microbiology, Microbial analysis, and method validation. Proficiency in basic computer skills (MS Excel, Word) is required. If you are a dedicated Microbiologist with a passion for making a difference in the healthcare industry, we encourage you to apply for this position and be a part of our team dedicated to improving global health outcomes.,

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Dedicated Centre Job Description Designation: Research Associate (9-I) or Senior Research Associate (9-II) Job Location: Bangalore Department: BBRC PD ARD GMP About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngenes clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- a strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Job Purpose (1-2 Lines): Analytical Research and Development working on Analytical GMP testing (AGT), and Syngene BMS Laboratory (SBL) stability programs Key Responsibilities Testing of samples (drug substance and drug product for release testing and stability) using chromatographic, dissolution, and wet analytical techniques under a GMP environment following cGMP practices Analysis of API clinical campaign samples manufactured in Syngene pilot plant Qualification or requalification of API reference standards. Performing instrument calibration and qualification Performing method validation, and method transfers Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab Deliver analytical results within the established windows and as per applicable guidelines Compliance & implementation of quality systems Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Electronic lab notebook documentation Miscellaneous lab responsibilities Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II; Technical/Functional Skills The candidate should have a good educational and theoretical, analytical chemistry background Good knowledge of analytical techniques The candidate should understand instrument calibration, qualification, method validation, and analytical testing Good understanding of documentation as per GxP requirements (electronic notebook) The candidate should have good proficiency in MS office tools Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred. Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II Behavioral Skills Strong commitment toward work and a high level of dedication, enthusiasm, and motivation Good speaking-listening-writing skills, attention to detail, proactive self-starter Ability to work successfully in a dynamic environment Should be able to work in a team and flexible for working in shifts. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cGMP grade materials. You will be directly involved in drafting technology transfer documents, risk assessments, process FMEA, method validation protocols, facility fit assessments, and other related activities necessary for the release and testing of microbial and mammalian fermentation-based products. You should have familiarity with analytical assays such as HPLC, GC, SDS-PAGE, agarose gel electrophoresis, densitometry, dd-PCR, RT-PCR, ELISA, UV-Visible spectrophotometry, western-Blot, as well as microbiological techniques like BET, BioBioburdend Sterility testing. Additionally, the position may entail assisting in cell bank testing and release under cGMP regulations and coordinating with third-party collaborators for external testing as needed. Your responsibilities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols, study reports, and publications with minimal supervision. You will work as part of the method transfer and method validation team, ensuring timely and successful completion of process transfers while addressing any unexpected technical challenges. We are looking for individuals who are enthusiastic, highly motivated, and capable of multitasking. The role requires working collaboratively within a team environment and independently across various aspects of projects related to microbial-derived products.,

Job Overview: As a Microbiologist at our organization, you will be responsible for conducting research, experiments, and analysis within the fields of microbiology, water technology, and environmental science. Your role will involve collaborating on R&D projects, devising innovative solutions, analyzing data, and working closely with internal teams and external partners. It is essential to ensure compliance with scientific standards while contributing to the advancement of the organization's research objectives. Job Description: In this role, you will be expected to: - Execute scientific research and experiments in the microbiology field. - Develop new processes and technologies related to water, wastewater, and environmental applications. - Analyze and interpret data, and prepare comprehensive reports and presentations. - Collaborate effectively with cross-functional teams and external stakeholders. - Ensure that the laboratory complies with quality and safety standards such as NABL and ISO 17025. - Act as an authorized signatory for NABL reports. - Stay abreast of advancements in the field and integrate new technologies for continuous improvement. Key Qualifications: - Hold a Master's degree in microbiology, Environmental Science, or a related field. - Possess at least 5 years of experience in scientific research within the microbiology domain. - Demonstrate strong analytical, problem-solving, and data interpretation skills. - Proficient in the use of microbial lab equipment, research tools, and data analysis software. - Exhibit excellent communication and teamwork abilities. - Have knowledge of Microbial Test methods of APHA/BIS/BAM/ISO. - Skilled and experienced in testing water and wastewater samples. - Must be an NABL approved Authorized signatory for microbiology scope. - Capable of method development, validation, and evaluation of measurement uncertainty following International Standards. - Conduct sample analysis of water, wastewater, and sludge samples and coordinate with R&D projects. - Perform method verification and measurement uncertainty assessment. - Conduct critical consumables evaluation, media quality checks, and culture handling. - Monitor environmental parameters and instruments for calibration, breakdowns, and maintenance. - Handle ILC/PT raw data and calculations efficiently. - Develop documentation and systems in line with the Quality Management System per ISO/IEC 17025:2017.,

Key Responsibilities: Conduct comprehensive Extractables and Leachables (E&L) analysis using Liquid Chromatography-Mass Spectrometry (LC-MS) for pharmaceutical packaging and drug delivery systems. Develop, optimize, and validate LC-MS methods for the detection and quantification of E&L compounds. Analyze, interpret, and report LC-MS data to assess potential risks associated with material impurities. Prepare and review Standard Operating Procedures (SOPs), study protocols, validation reports, and analytical reports for E&L studies. Ensure compliance with regulatory guidelines (USP, ICH, FDA, ISO) and Good Laboratory Practices (GLP). Maintain, troubleshoot, and calibrate LC-MS equipment, ensuring the instrumentation is always operating at peak performance. Collaborate with R&D, formulation, packaging, and quality assurance teams to ensure the safe use of materials in drug products. Stay updated on current industry standards and evolving regulatory requirements for extractables and leachables testing. Participate in internal and external audits, providing technical expertise on E&L testing as required. Effectively manage laboratory workflows to meet project timelines and ensure accurate, high-quality data generation.

Department: ADL Experience: 5+ Years Qualification: M.Sc. (Analytical Chemistry) Location: Vadodara Job Description: We are looking for an experienced Executive in the Analytical Development Laboratory (ADL) to support R&D activities. The role involves method development, validation, analytical testing, and ensuring regulatory compliance of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for pharmaceutical substances and products. Conduct analytical testing using HPLC, GC, UV, Mass Spectrometry, etc . Troubleshoot analytical issues and ensure data accuracy and reliability. Adhere to quality control protocols and support audits (Customer/Regulatory). Maintain and calibrate lab instruments and stay updated with new analytical technologies. Follow QMS, SOPs, and safety standards. Skills Required: Strong knowledge of analytical chemistry techniques. Experience in pharmaceutical R&D. Good documentation and communication skills.

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

Vipul Organics Limited (VOL) is a leading manufacturer of specialty chemicals and colorants, committed to innovation, quality, and environmental safety. With a strong legacy and global presence, we are now looking to strengthen our team with a dedicated Instrumentation Chemist at our Palghar unit. Key Responsibilities: Conduct precise chemical analysis using Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) . Ensure regular calibration, maintenance, and troubleshooting of GC and HPLC instruments. Record, analyze, and report test results in a timely and accurate manner. Maintain laboratory standards as per safety, regulatory, and quality protocols. Support the QC and R&D teams in routine and special analysis projects. Candidate Profile: Education: B.Sc. in Chemistry (mandatory) Experience: 1- 2 years in instrumental analysis (GC and HPLC expertise required) Skills: Strong analytical ability, attention to detail, and familiarity with laboratory documentation Availability: Immediate joiners preferred Job Location: Palghar, Maharashtra

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 02-08-2025. 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 : 02-08-2025 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

As a part of this role, you will be responsible for sample preparation, daily calibration, and the maintenance of equipment, including keeping a detailed log of all activities. You will also be involved in method development, method validation, and conducting sample analysis in accordance with ICH M10 guidelines. Operating, maintaining, and calibrating LCMS equipment will be a crucial part of your responsibilities. In addition, you will be required to adhere to documentation procedures as outlined in Bio analytical SOPs and ICH M10 guidelines. This will involve thorough record-keeping and ensuring all documentation is accurate and up to date. Furthermore, you will be expected to review data and reports to ensure quality and compliance with relevant standards. Your attention to detail, ability to follow guidelines meticulously, and commitment to maintaining accurate records will be essential for success in this role. If you are looking for a position that offers diverse responsibilities in a dynamic environment, this opportunity may be the perfect fit for you.,

As the Quality Control Manager for injectable products, your primary responsibility is to ensure the adherence to quality control procedures in compliance with cGMP and regulatory standards such as FDA and EMA. You will oversee the testing and release of raw materials, in-process materials, and finished products, ensuring the proper documentation and traceability of quality control processes. Leading and managing the quality control team is a key aspect of your role, where you will provide mentorship, training, and motivation to ensure the team's effectiveness. Daily coordination of activities, task assignments, and setting priorities to meet production schedules are essential tasks. Regular performance evaluations and fostering continuous improvement within the team are also part of your responsibilities. You will be in charge of supervising the inspection and testing of injectable products for stability, sterility, endotoxins, potency, and other specifications. Sampling of materials and products for testing, as well as reviewing and approving laboratory test results, fall under your purview. Ensuring regulatory compliance with local and international standards, managing quality audits, and inspections by regulatory agencies, and implementing corrective and preventive actions are crucial aspects of your role. Root cause analysis of quality-related issues, initiating corrective actions, and collaborating with other departments for issue resolution are also part of your responsibilities. Overseeing the qualification and calibration of QC equipment, ensuring validation of analytical methods, and maintaining accurate documentation of test results and quality-related activities are essential tasks. Leading initiatives for continuous improvement, developing training programs for employees, and maintaining industry standards and SOPs are also key responsibilities. To qualify for this role, you should have a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field, along with 5-8 years of experience in quality control in a pharmaceutical or injectable manufacturing environment. Strong knowledge of cGMP, FDA, EMA guidelines, laboratory testing methods, and quality management systems is required. Strong leadership, organizational, and communication skills, problem-solving abilities, and attention to detail are essential skills for this role. Proficiency in Microsoft Office and quality control software systems is also necessary. Excellent decision-making skills, interpersonal skills, and a proactive approach to quality management and compliance are personal attributes that will contribute to your success in this role.,

Division Department Sub Department 1 Job Purpose Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements Key Accountabilities (1/6) Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission Conduct extensive literature search Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTIs on different analytical instruments under GLP environment Conduct Fate and Purge studies/carryover studies Perform method validation Prepare specification based on carryover studies Perform method transfer to manufacturing units for routine QC analysis Key Accountabilities (2/6) Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples for impurities Review the entire process to identify the source of impurities Perform degradation study to identify impurities Analyse packing material in case of leachable and extractable Key Accountabilities (3/6) Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose Perform chemical and physicochemical analysis to arrive at the purity, potency and structural identity of the molecule Store impurities as per chemical properties Key Accountabilities (4/6) Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API Incubate samples at various conditions Select packing material Perform analysis of stability samples Compile trend and identify degrading impurity Evaluate shelf life of the drug substance for expiry conclusion Key Accountabilities (5/6) Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues Attend various webinars, conferences Evaluate various demo datas generated by instrument manufacturers at their demo labs Compare various parameters like shorter run time, solvent consumption, cost factor and environment safety Key Accountabilities (6/6) Major Challenges Changes in the Regulatory guidelines: Keeping abreast with latest regulatory guidelines and interaction with RA department Conflict regarding the priorities of samples: Interaction with cross-functional team along with the managers to prioritise the samples Delay in cross-functional activities: Interaction with immediate supervisor for clarity of responsibility Difference in instrument compatibility for analysis: Escalated to supervisors Key Interactions (1/2) API R&D/ F R & D for planning, product information and result discussion (daily) RA for regulatory discussion for Deficiency, DMF filing (as per need basis) IP or patenting any product or getting information of any known patent (as per need basis) Units for sample requirement, Method transfer, Method validations, investigations (weekly) Purchase & Imports for impurities/chemicals, instrument and Equipment (as per need basis) HR for Personal discussion and organisation rules and regulation, company policy discussion (as per need basis) Key Interactions (2/2) Outsource Labsfor external analysis (weekly) Vendors-Instruments/Equipment for service and support (as per need basis) Application specialists for application support to resolve any challenging queries (as per need basis) Dimensions (1/2) Minimal error for lab compliance and maximise output Maximise instrument utility by working in shifts Online delivery of analytical data to R&D Ensuring 100% compliance with the regulatory Meet the turnaround times for projects Publish two papers in a year Dimensions (2/2) Number of trials on various techniques during development stages Key Decisions (1/2) Result discussion for online monitoring of samples with R&D Change in method of analysis with supporting analytical data to the respective Group Leader Key Decisions (2/2) Education Qualification Sc Relevant Work Experience Minimum 15 years of experience in pharmaceutical industry with analytical experience Good presentation and communication skills are preferable Show

Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of processing/packing as per requirement. To review & approval of API Analytical Method Transfer Protocol/Report and method validation documents. Preparation & review of Annual Product Quality Review. Preparation, Review & Approval of Hold Time Study Protocol/Reports, and other study protocols/reports Work Experience 7-9 year Education Masters in Science or Pharmaceutical Chemistry Post Graduation in Pharmacy Competencies

Job Purpose and Impact The Assistant Manager - QC will provide expertise with all daily operations in quality control laboratories. In this role, you will support the buildup and maintenance of the rapid technology platform by providing reliable accurate analytical figures as well as perform validation and troubleshooting of new analytical methods to ensure they meet the requirements and deadlines. Key Accountabilities Provide analytical support to Rapid Technology Application platform by releasing precise and accurate results and ensure scope of testing parameter is sufficient to build MPA module. Provide ongoing technical support to stakeholders, investigate quality problems and deliver improvement actions with follow up. Perform method validation and verification to roll out new testing method in the lab. Document standard operating procedures, identify possible trends in testing results with data analysis software and provide input to team members to improve quality control system. Organize and maintain accurate and pertinent data, including spreadsheets, graphs and reports. Maintain systems and techniques for reporting data across functional areas. Organize and participate ring tests with the goal to check and control methods and equipment. Handle basic issues and problems under direct supervision, while escalating more complex issues to appropriate staff. Other duties as assigned Qualifications Minimum Qualifications Bachelor's degree in a related field or equivalent experience Preferred Qualifications "Able to work independently, possess positive working attitude with high initiative level, and communicate effectively" Necessary English reading capacity Experience with chemical analysis (preferable)- oils and fats, starch, sweeteners, etc. Knowledge in calibrate, maintain and troubleshoot various analytical instruments such as GC, HPLC, AAS, ICP, NIR etc Able to demonstrate sound understanding of Statistical Process Control (SPC), method validation and report writing Minimum of Three years of working experience in the Food industry Lab.

Role Name In Community Title Senior Executive Department Sales Hiring Manager Deepak Subramanian Brief Role Description Narayana One Health is in the process of setting up a strategic team tasked with bringing health and insurance closer to patients. The initiative involves setting up primary and secondary care services that are easily accessible to patients and are supported by hyper-responsive processes built to keep patient needs and satisfaction at the center of focus. The initiative aims to bridge the gap between Narayana One Health’s in-hospital offering and patient’s everyday healthcare needs and provide patients access to a continuum of care tailored to their specific healthcare needs. Narayana One Health is looking for Senior Executives for Bangalore, India. This is an individual contributor role in an employee-oriented, high-performance environment that emphasizes spreading Nayana One Health Care Benefits in Bangalore (Karnataka). Your role will entail, Qualification of Leads (via various channels), by calling them, meeting face to face and selling Narayana Arya insurance plans to customers and briefing them about the HealthCare benefits of Arya Insurance via individual reach and through a referral channel model known as One to Many. Responsibilities: 1. Identify Engage and build relationships with Key Community Leaders of Cultural Associations, RWAs etc. 2. Manage Engagement with Community by executing agreed formats of events and sponsorships 3. Generate Interest for Arya Insurance Plans 4. Carry out Right Execution Daily (RED) and adhere to P-100 Program Guidlines 5. Ensure correct Activation and closures at Individual and at channel level. 6. Deliver Monthly targets on Inputs and Outputs Requirements and skills 1. Graduate Degree with Minimum 3-4 years' experience in sales (B2C, B2B or both)- preferred experience in Insurance or financial products and services. 2. Keen Interest in Healthcare and Health Insurance. 3. Passion for new Business Initiatives. 4. A knack for sales and positioning an idea. 5. Highly creative with experience in identifying target audience. 6. Good Communication Skills. 7. Proficient in using CRM, Analytical Tools. Location – Bangalore

Exp. in ARD/AMD of minimum -15 to 20 years Lead the development and validation of analytical methods Prepare and review technical documentation Drive analytical strategy in global or cross-functional project teams

As an On-site Application Chemist at Toshvin Analytical, you will play a crucial role in providing post-sale customer support on GCMS-MS applications. Your primary responsibility will involve visiting customer sites on a daily basis or being stationed at one customer location for a period of 6 to 12 months anywhere in India. In this role, you will support customers in method development, optimization, and validation activities related to their sample matrices. Your expertise in troubleshooting customer application issues and demonstrating advanced software capabilities will be essential. You will be expected to collaborate with the local application lab principals to address any unresolved customer application requests. Additionally, conducting application training sessions for customers" chemists to ensure effective utilization of the system and software will be part of your responsibilities. You will also prepare detailed application support reports and deliver PowerPoint presentations to customers as needed to communicate the activities carried out and results achieved. To excel in this role, you should have 6-8 years of experience in Pharma/Testing Lab/Food Testing Lab, with hands-on experience in TQMS, preferably with Shimadzu equipment. Your background should include expertise in analytical method development (AMD) activities, method development & validation protocols, proficiency testing requirements, and knowledge of existing regulations in Pharma/Food/EU Norms/Codex Test Methods. A minimum qualification of B.Sc. in Organic Chemistry or Analytical Chemistry is required, while an M.Sc. or equivalent post-graduation in Organic/Analytical Chemistry is preferred. Key Success Behaviours for this role include proficiency in handling chromatography sampling techniques such as Headspace Samplers, Thermal Desorption, Pyrolyzer, etc. Experience in analytical method development, optimization, and validation using these techniques is crucial. Familiarity with application workflows in relevant industry segments and knowledge of global regulations will be advantageous. Effective communication skills in English, both spoken and written, along with a willingness to travel extensively locally and outstation for customer support activities, are essential traits for success in this position. If you are a bright, motivated, and committed individual seeking a long-term career opportunity with one of the leading instrumentation companies in India, we encourage you to submit your CV to careers@toshvin.com. Join our team of experienced professionals at Toshvin Analytical, where growth meets opportunity.,

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: