279 Glp Jobs - Page 3

? Job Description: ? ? We are looking for a skilled and proactive QA/QC professional with 2 5 years of experience to join our quality team. The candidate will be responsible for executing and overseeing quality assurance and quality control activities in compliance with regulatory and company standards. ? ? Key Responsibilities: ? ? Quality Control? ? Perform analytical testing of raw materials, in-process samples, and finished products. ? ? Operate, calibrate, and troubleshoot instruments such as HPLC, UV-Vis, GC, FTIR, and KF. ? ? Prepare and review analytical documentation including test reports, COAs, and calibration records. ? ? Guide and Mentor QC Executives / Trainees for analytical testing ? Quality Assurance? ? Review batch manufacturing and packaging records (BMR/BPR). ? ? Investigate and document deviations, OOS, OOT, and implement CAPA with timely closure. ? ? Review and manage controlled documents (SOPs, protocols, forms) issuance, retrieval, and archival. ? ? Perform internal audits; support regulatory audits (e. g. , WHO, ISO, etc. ). ? ? Oversee GMP, GLP, hygiene training for production and QA/QC staff. ? ? Coordinate stability studies, analyze trends, and maintain stability protocols and logs. ? ? Ensure data integrity in documentation and electronic systems. ? ? Participate in risk assessment and mitigation for quality events. ? ? Support technology transfer, scale-up, and cross-functional quality activities. ? ? Evaluate and audit vendors and suppliers as part of QA oversight. ? ? Requirements: ? ? 2 5 years of hands-on experience in analytical techniques and instruments in a regulated environment. ? ? Strong understanding of cGMP, GLP, and ICH regulatory requirements. ? ? Proficient in analytical instrumentation and documentation practices. ? ? Ability to handle audits, deviations, and quality systems independently. ? ? Excellent communication, collaboration and organizational skills. ? ? Team player with attention to detail and accuracy. ?

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOP s , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COA s as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Bachelors degree

Division Integrated Product Development Department Global Respiratory Sub Department 1 Respiratory -Formulations RD - DPI Job Purpose Execute the core method development activities and conduct analysis of routine as well as stability samples to finalize specifications and ensure timely delivery of product to unit. Key Accountabilities (1/6) 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 maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms 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 Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations Key Accountabilities (2/6) Key Accountabilities (3/6) Key Accountabilities (4/6) Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Key Interactions (1/2) Key Interactions (2/2) Dimensions (1/2) Dimensions (2/2) Key Decisions (1/2) Key Decisions (2/2) Education Qualification M. Sc. (Analytical Chemistry) / M. Pharm Relevant Work 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

Job Purpose: The QA Auditor is responsible for evaluating and ensuring compliance with applicable regulatory standards, including Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), across clinical research and laboratory operations. This role supports the organization's commitment to quality and regulatory integrity by conducting internal and external audits, identifying non-compliance, and driving corrective and preventive actions. The QA Auditor plays a critical role in maintaining high standards of data integrity, patient safety, and regulatory compliance, while supporting continuous quality improvement in alignment with international guidelines and sponsor expectations. Role & responsibilities: 1. Planning, Execution, and Oversight QA review of protocols, study/validation plan, and amendments, if any. Audit Planning and Management To plan & conduct in-process audit of studies and method validation to assure compliance with WHO-GCLP & applicable principles of GLP and ICH-GCP, SOPs, protocol, study plan/validation plan, STP, and applicable regulatory guidelines. Conduct retrospective audit of study raw data & report and validation raw data & report to assure compliance with WHO-GCLP and applicable principles of GLP & ICH-GCP, SOPs, protocol, study/validation plan & applicable regulatory guidelines, and prepare QA statement/authentication. To conduct system audit of various departments as per pre-defined schedule to assure compliance as per in-house SOPs and prepare & communicate audit report. Vendor audits/supplier audits. To review the Analytical and functional characterization data 2. Oversight of QMS Review of SOPs Monitoring and review of deviations Monitoring and review of change controls Monitoring corrective and preventive action 3. Assist in Sponsor Audits/Client & Regulatory Inspections To assist Lead, QA/designee to host sponsor/client audits and regulatory inspections. To assist Lead, QA/designee to address sponsor/client audit response as well as its closure (as applicable). To assist Lead, QA/designee to review regulatory audit response and queries as well as its closure (as applicable). To assist Lead, QA/designee to track, prepare and submit regulatory applications and follow-up until its approval. 4. Review & Monitoring To prepare and review quality assurance SOPs and review applicable operational SOPs. To review and provide inputs on audit reports prepared by QA team for delegated audits. To ensure closure of all raised observations and provide QA authentication. To ensure the controlling and distribution and QA data archiving. To ensure the controlling and distribution of documents. To update quality manual & its annexure periodically To assist Lead, QA/designee for trend analysis and quality review meetings. 5. Training & Development To train the new joiner in QA department on various QA aspects as well study/validation aspects as applicable. Maintain quality culture within department. 6. Other Responsibilities Any other responsibilities assigned by head, quality assurance/designee

To execute sampling and analysis of Raw materials along with relevant laboratory documentation. To execute analysis of finished goods, In-process, packing materials and cleaning samples along with relevant laboratory documentation. Result reporting after completion of analysis & relevant documentation . Before starting an analysis, following points (but not limited to) must be checked: Check all the instruments on the equipment required for the analysis are in working condition and are in calibrated state. Checking and ensuring proper status labels after confirming availability of all the requirements (as applicable) for analysis such as approved control procedure, analytical protocol, reference standards, chemicals, reagents, GC/HPLC columns, glassware, water preparation equipment, water bath, sonication baths, mobile phase bottle etc . Ensure the online documents pertaining to day-to-day analysis are efficiently completed in timely manner. Reporting the activities daily to immediate supervisor. Ensure timely calibration & preventive maintenance of equipment/instrument. Destruction of respective records & QC Samples like Retention samples of Raw Materials, analyzed samples. To take out the quality reports, Data / Results entry in SAP system. To prepare and maintain the working standards & documentation. Ensure timely raising and closure of deviations, quality events, change controls, OOS/OOT. To execute Analytical Method Validation / Transfer, cleaning validation as per approved procedure & protocol. Preparation and maintenance of Analytical data sheets and Excel spread sheets. Adequate knowledge of all equipment/instruments & their functioning in the laboratory & assist in equipment/instrument qualification activities. Ensuring the quality and integrity of all GxP data and documentation generated. Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111. Ensure fully Engagement and Involvement regarding awareness, clarity maintained related to data integrity. Ensure the 21 CFR Part 11 compliance in the Laboratory. Effective implementation of practices like cGMP & GLP, ISO 9001, ISO 14001, ISO 22000, ISO 18001, HACCP and SQF in QC Dept. To follow and maintain the standard chromatographic practices. Ensuring good house-keeping and accident free working in the Laboratory. To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs, safe, secure storage of hazardous, toxic, explosive, corrosive, irritant materials. Ensure proper maintenance of logbooks in QC lab. To fulfill the analytical requirements of FSSAI regulation. To undergo assigned trainings on cGMP, HSE & departmental procedures / policies. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. To identify & communicate incidents, QEHS non conformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of waste. Masters in Science

Job Title: Study Monitor Support Specialist Introduction to role: Are you ready to dive into the world of non-clinical study monitoring? As a Study Monitor Support Specialist, youll play a pivotal role in supporting the Study Monitor group within Regulatory Toxicology and Safety Pharmacology. Your contributions will be vital in ensuring the smooth execution of studies that pave the way for groundbreaking medical advancements. Accountabilities: - Support the study monitoring of in vitro safety pharmacology (hERG) studies. - Assist NonClinical Toxicology Study Monitors with key study activities. - Provide essential support for external study monitor activities. - Maintain and update supporting documents. - Identify and implement effective toxicology study processes to enhance efficiency and simplify operations. - Continuously evaluate the end-to-end process for CRO study management to identify weaknesses and gaps, focusing on improvement and simplification. - Manage financial aspects of study conduct, including approval and review of Statements Of Work, Invoices, and Purchase Orders. - Maintain a tracker for ongoing study costs. - Support ad hoc requests for metrics and information gathering activities. - Perform QC checks of submission documents. Essential Skills/Experience: - Fluent in English (spoken and written). - Experience working in a GLP Toxicology lab with an understanding of practices, principles, and concepts associated with planning and delivering non-clinical toxicology studies. - Ideally, experience relevant to the delivery of in vitro electrophysiology assays measuring activity at cardiac ion channels (including hERG). - Ideally BSc in Pharmacology / Toxicology. - Experience delivering to multiple concurrent projects, with the ability to take ownership. - Strong stakeholder management skills with excellent communication skills. - Experience in improvement projects with a drive to ensure efficient ways of working. - A dedicated team player with excellent communication and influencing skills, experienced in working in multidisciplinary matrix teams across various geographical locations. - Results-oriented with high scientific standards combined with a delivery focus to support project execution. - Proficient in the use of Microsoft Office products. At AstraZeneca, we are driven by curiosity and courage, constantly exploring new scientific frontiers to tackle some of the worlds most complex diseases. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to achieve breakthroughs that impact billions of lives globally. Here, you will find an inclusive environment where collaboration thrives, empowering you to make bold decisions and celebrate successes along the way. With opportunities for lifelong learning and career growth, AstraZeneca is where you can truly make an impact. Ready to take on this exciting challenge? Apply now and be part of our journey to redefine whats possible in healthcare! Date Posted 29-May-2025 Closing Date

Key Roles & Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities. 5. Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. 6. Effective maintenance of R&D records, distribution and archival systems. 7. Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory. 8. Ensure R&D team is trained for their relevant job function and GMP/ GLP training. 9. Provide quality related inputs to new projects, existing project, up gradations etc. 10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified. 11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site. 12. Establish raw material standards by studying manufacturing/ R&D requirements-conferring with suppliers. 13. Responsible to follow the safety and environmental procedures deployed in the site. Graduation and above in Science / Pharmacy

Job Summary : Experienced QC professional with 8-10 years in pharmaceutical quality control and compliance. Responsible for preparing specifications, test methods, and maintaining GMP, GDP, and GLP standards. Supports regulatory affairs, handles deviations, OOS, and change controls, and reviews analytical reports. Proficient in SOP creation, method updates, and team training as per cGxP and regulatory guidelines. Responsibilities: Preparation and updating specifications and test methods to ensure compliance with statutory and company standards Preparation of specification for input materials, intermediates, active pharmaceutical ingredients, finished products and stability products to ensure compliance with company standards. Maintenance of GMP, GDP & GLP in work To maintain Quality Control documents as per statutory requirements Updation and analysis of methods and analysis as per current cGCPL guidelines and regulatory requirements. Support to Regulatory affairs departments, as required Adherence to cGMP, ISO 14001, FSSC 2200 and HACCP norms and guidelines as required Preparation of SOP and related documents Initiating and involving in the incident, deviation and OOS. Initiating change control and edit form to make any changes required in the specifications, standard testing procedures, raw data sheets and SOP and closing the same Review and approval of analytical reports as required Training of concern persons related to quality documents as required Education Qualification: MSc Chemistry Years of Experience : 8 to 10 Years

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, define, analyze, and document testable business requirements, collaborating closely with customers, end users, and the IT team. Leverage good communication and analytical skills, business relationships, and business process expertise to understand, document, assess, and drive business change needs to accelerate process improvement and business growth. Drives re-use of existing solution capability or introduction of new technology to achieve program or project objectives Works independently and simultaneously on multiple projects with various domain experts to understand current business process landscape, enterprise alignment, and growth. Business Analysis ownership for [functional processes], Identify and evaluate potential solutions, favouring existing invest application estate. Prepares cases which define potential benefits, options for achieving these benefits through development of new or changed processes, and associated business risks. Measurably improve business process capability and performance indicators for delivered projects Attain a high re-use of technology while driving process standardization for owned processes Drives effective requirements' definition that creates objective, testable requirements that results in a business solution which meets or exceeds the defined objectives. Create functional requirements in Use Cases. Coordinate requirements walk-through and signoffs, verifying with collaborators that Use Cases and process models accurately portray specific business needs. Recommends options that best fit the business needs, value proposition and strategic roadmap. Identifies, analyses, and fixes the root cause of business and technical issues. What will you need to be successful? Education: Bachelors or masters degree in computer science, information systems, business administration, or other related field, or equivalent work experience. Experience : Minimum 5-7 years of relevant technical or business work experience . With at least 3 years of experience in information technology & regulatory affairs . Certification in business analysis is preferred. Proven Experience with Rimsys and PTC Windchill (PLM systems) Solid experience working within GxP-regulated environments , including validation of systems, Quality Systems, and compliance with regulatory standards Business process design and reengineering techniques and methods. Business analysis: takes responsibility for investigative work to determine business requirements and specify effective business processes through improvements in information systems, information management, practices, procedures, and organizational change. Selects and embraces suitable business analysis methods, tools, and techniques, selecting the appropriate approach from predictive (plan driven) or adaptive methods (iterative/agile). Collaborates with partners at all levels in the conduct of investigations for strategy studies, business requirements specifications, and feasibility studies. Designs and manages tests of new/updated processes. Manages selection/creation of relevant scenarios for testing and ensures that tests reflect realistic operational business conditions. Ensure tests and results are documented, reported to partners, and are available for specification of user instructions. Highlights issues and risks identified during testing to business customers. Defines and manages prioritizing, requirements definition, and prioritization activities for initiatives of medium size and complexity. Facilitates input from customers, provides constructive challenge, and enables effective prioritization of requirements. You Unlimited. We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Other reasons why you will love it here! Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance. Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave. Your Wellbeing: Parents/Parents in Laws Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave. Flexibility : Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About the Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e. g. , analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc. ) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e. g. , LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for assigned laboratory related area/activities (e. g. , chemical / reagents / consumables / samples / column / glassware management etc. ). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e. g. , Up4Growth). Minimum Requirements: Masters in Life Science (e. g. , analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc. Fluent in English (oral and written). Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience: Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills: Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages : English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Oversee and execute analytical testing of raw materials, in-process samples, and finished products. Ensure compliance with cGMP, GLP, and regulatory guidelines. Review and approve analytical data, test results, and documentation. Troubleshoot analytical instruments like HPLC, GC, UV, and FTIR. Support method validation, stability studies, and regulatory audits. Implement quality improvement initiatives and ensure data integrity

Literature survey for assigned projects. Analysis of innovator samples as and when provided. Preparation of test report against the Test request form received and compilation of results if necessary. Analytical method development of drug substances and drug products. Validation of drug products and verifications on activities for drug substances. To act as instrument in-charge for the allotted instruments and responsible for calibration and maintenance of the same. Carry out basic trouble shooting for instrument related issue, whenever required. ll Impart training with respect to instrument handling to junior colleagues. Preparation and checking ofMDR, MVR and MOA. Maintain GLP Activity in Laboratories. To participate in method transfer, critical analysis activity at plant or outside testing laboratories Analysis of development batches and stability batches. Writing of experiments online in Laboratory Notebooks (LNB) with all details. Processing of raw data and calculations after completion of each analysis.

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Method development & Validation ( HPLC /GC/ UV/ Potentiometer etc..) for both Solid orals and Injectables & Handling of all analytical instruments/ Equipments, SOPs prepation, SPEC and STPs prepation/ review,Stability samples analysis .

Requirement is for a dynamic young man having 3 to 7 Years experience in store management of a Pharmaceutical Formulation manufacturing Company for bulk Packaging Material . Added qualifications for Stores Management will be an advantage for consideration. The candidate should have complete knowledge of GMPs GLP and Good Storage Practices. Packing material receiving & update document Material Inward, checklist, GRN, Material arrange location wise etc. Experience: 3 to 7 Years (B.Pharma Candidate preferred Graduate) Age: Maximum 35 Years

Job description: Leadership role to manage team size of 20+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Planning and excution of projets in Analytical services Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Ensuring the compliance related to all the activities Method development/Validation experience in LC-MSMS, GC-MSMS and ICPMS instrument Preparation and Implementation of SOPs related to E& L,Stability studies, general laboratory processes and best guidance. Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab Monitor and management of day-to-day laboratory activities Subject Matter Expert for guiding extractables and leachable studies, Stability studies, Nitrosamine studies, PSD, PXRD, HPLC, GC-MS/MS, LC-MS/MS, ICP-MS, IC, Dissolution, UV-Vis, etc., including designing the preparation of protocols and report Extensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COA Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc. Resolving the team conflicts and provide training to the team for development and empowers team members Provide scientific and leadership direction to team members Knowledge on LIMS Supporting in setting up lab facility and instrument distribution Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab. Skills Required: For M.Sc, 20-25 years of Analytical R&D/QC experience in CRO environment Excellent technical, problem-solving, writing, influencing and communication skills Strong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teams Demonstrative communication skills and confident in conveying information to internal/ external customers Skill for resolving the team conflicts and provide training to the team for development and empowers team members Behavioral Competencies: Excellent oral / written communication skills and flexibility to work in a dynamic environment Excellent in Knowledge sharing at all levels. If you're a fit, send your resume to . Please share only relevant profiles. Qualifications M.Sc -Analytical Chemistry/Organic Chemistry/General Chemistry/Industrial Chemistry

Experience (years) 20-22+ years relevant experience or PhD in Microbiology with at least 15+ years of relevant industry experience. Job description: In-depth scientific expertise in Genotoxicology, with significant experience in designing, executing, and interpreting genetic toxicology studies in both regulatory (FDA, EMA, ICH, and OECD guidelines) and non-regulatory environments. Responsible for the execution, planning, performance, reporting/archiving, and management of studies such as the Bacterial Reverse Mutation Test (Ames Test), Bone Marrow Micronucleus Test, Chromosome Aberration Test, and In Vitro Micronucleus Test etc. Preparation of study plans, protocols, amendments to study plans, study reports, creation, and review of SOPs. Lead and manage a team of genetic toxicologists, providing mentorship and guidance to achieve departmental and organizational objectives. Oversee study directors across multiple studies and ensure consistent performance. Train and onboard new staff, ensuring they meet expected proficiency levels for quality work in compliance with GLP standards. Prepare monthly forecasts and reports, and plan for the effective use of resources. Focus on maintaining strong client communication, ensuring timely delivery of services, and fostering repeat business. Oversee laboratory maintenance, equipment validation and calibration, and procurement of reagent supplies. Participate in GLP/NABL activities, inspections, and ensure adherence to regulatory compliance guidelines; address Quality Assurance checklists and GLP compliance. Collaborate with HOS/HOD in budgeting, costing, planning, and conducting studies, as well as in the development of new platforms and operational activities. Support to business development and marketing efforts, generate new business leads alongside the BD team. Standardize and implement new in vitro test procedures. Qualifications / Skills Required: Masters in Microbiology (M.V.Sc / M.Sc) with at least 20-22+ years of relevant industry experience or PhD in Microbiology with at least 15+ years of relevant industry experience Understanding of the agrochemical and pharmaceutical R&D process Strong problem-solving skills and the ability to develop innovative solutions. Experience in managing internal and external collaborations. Willingness to adapt to rapidly changing scientific and regulatory environments. Effective team collaboration skills to achieve project goals, objectives, and deadlines. Behavioral Competencies: Strong oral and written communication skills. Ability to adapt and work efficiently in a dynamic environment. Excellent time management skills to effectively handle multiple projects. Highly motivated, takes responsibility for personal improvement, learning from experience and new situations. Strong training, presentation, analytical, and computer skills Thinks of and/or encourages new ideas and keen to experiment and see ideas implemented. Qualifications Qualification M.V.Sc / M.Sc. in Microbiology / PhD in Microbiology

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others. Role to manage team size of 1 to 3 scientists (M.Sc.) Good team player, should be able to lead the team of 1-3 scientist (M.Sc.) and monitor their day-to-day activities along with his own to complete the time bound tasks Strong interpersonal skill and managing cross functional teams Sound knowledge in synthetic/Medicinal chemistry Niche area chemistry experience is preferred Performing fundamental literature & patent searches related to project activities and develop alternative strategies Sound knowledge of scientific search engine such as SciFinder, Reaxys etc. Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc. Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab Qualifications For M.Sc, 7-10 years of Discovery/Medicinal Chemistry R&D experience and for PhD, 2-4 years of experience in discovery/medicinal Chemistry CRO. Additional Information Excellent technical, problem-solving, writing, influencing and communication skills Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Demonstrative communication skills and confident in conveying information to internal customer

Responsible to develop, implement and be responsible for the production plan for their respective departments. To deliver timely and accurate analysis of samples to meet customer commitments. Be responsible for record control, measurement traceability and testing results review and approve the testing reports. Maintenance of Standard Reference Materials, Chemicals, Reagents, and Glassware used in the laboratory. To support the installation of additional analytical equipment, methods for the analysis of all kinds of food/feed/water matrices based on the transfer of existing methods and knowledge form the Eurofins Group Preparation of standard operating procedures. Validation of non-standard test methods and non-routine test methods. Be responsible for skill training, reviewing, and appraising the laboratory staff. Be responsible for configuring and monitoring the instrument, equipment, and its environment conditions. Organize and supervise confirmation and verification of the testing methods. Estimation of measurement uncertainty for test parameters Scope preparation for new parameters Be responsible for control of nonconformity work, complaint, Retest request etc Reliable, independent, and service oriented approach to work Qualifications 8-10 years experience of working in food testing laboratory. Strong understanding of ISO 17025 implementation and accreditation process. Proficient in analytical techniques of wet chemistry, proximate analysis, heavy metals analysis. Should have strong leadership skills to handle team of analysts, allotting and supervising the task to team and also monitoring and evaluating the work done. Preferrably a food analyst Graduate in B.Sc / M.Sc in Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Plan and execute advanced microbiological research to develop new products and optimize existing processes. Conduct microbial culturing, isolation, identification, and characterization using classical and molecular biology techniques.

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with U.S.-based Biometrics leadership to align deliverables and timelines across global development programs. Support biostatistical leadership by overseeing the development and validation of Statistical Analysis Plans (SAPs), as well as generation of tables, listings, and figures (TLFs) for clinical study reports (CSRs). Supervise the creation and validation of SDTM and ADaM datasets in compliance with CDISC standards. Collaborate with Clinical Data Management leads (where applicable) to ensure effective Clinical Data Management practices and data quality. Ensure alignment of Biometrics activities with overall project goals, timelines, and regulatory requirements. Monitor workload, resourcing, and productivity across the India Biometrics team. Facilitate communication and integration across functional teams (Biostatistics, Statistical Programming & Clinical Data Management). Mentor and support the development of team members across both disciplines. Stay current with industry standards and regulatory expectations in Biostatistics, Statistical Programming , CDISC, and Clinical Data Management practices. Qualifications: Masters degree in Biostatistics, Statistics, Clinical Data Science, Life Sciences, or a related field. 15+ years of experience in the pharmaceutical, biotechnology, or CRO industry within biostatistics, statistical programming, and/or Clinical Data Management. Strong working knowledge of clinical trial processes and relevant regulatory requirements (e.g., GCP, CDISC, BLA/NDA submissions). Hands-on expertise Biometrics with all three functions (Biostatistics, Statistical Programming & Clinical Data Management). Ability to lead and manage cross-functional technical teams. Strong project management, problem-solving, and interpersonal communication skills. Proficiency in relevant tools and platforms (e.g., SAS, R, EDC systems, CDMS, Veeva eTMF, Quality Docs, and eQMS platforms). Experience working in a global team structure and across time zones. Proven track record of leading and managing cross-functional biometrics teams, with experience in overseeing the development and validation of statistical analysis plans and clinical study reports. Experience with CDISC standards (SDTM and ADaM) and proficiency in statistical programming languages (e.g., SAS, R). Familiarity with electronic data capture (EDC) systems and Clinical Data Management systems, with a strong understanding of data integrity and quality practices. Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment, with excellent organizational and problem-solving skills. Strong interpersonal and communication skills, with the ability to collaborate effectively with global teams and senior leadership. Commitment to continuous professional development and staying current with industry trends and best practices. Experience with Microsoft-based applications and ability to learn internal applications/systems, including Veeva platforms such as Quality Docs, eTMF, and CDMS. Experience with eQMS systems is a plus. Working conditions: This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

M. Sc Organic Chemistry with experience of process development in API R&D Should be ready to work in shifts Should have deep understanding of documentation and GLP Should have understanding of HPLC, GC and analytical techniques

Kamla Homes is looking for Trainee Officer - Packing to join our dynamic team and embark on a rewarding career journey Assist in the packing line operations and material setup Check packaging materials and labels for accuracy Maintain cleanliness and batch documentation Learn GMP guidelines and SOP compliance

Min. 8 years experience from API /Chemical organization Good knowledge on GMP & GLP activities & ensure its executions Should have experience handling QC instruments including GC & HPLC. Calibration, Qualification & Preventive maintenance Lab Instruments. Should able to prepare / maintain /implement documents as per standard practices. Good knowledge of ISO standard, Regularity & customer requirements & Lab safety and its compliance. Analysis of IP, Intermediate , RM & FP testing in time with appropriate release documentation and review of analysis data. QMS & Audit compliance with respect to Quality control activity.

The Position Organization : - Jubilant Biosys Designation & Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience. Experience in a drug discovery industry/ CRO in DMPK department. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.