371 Method Validation Jobs - Page 15

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 22-08-2025. 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 : 22-08-2025 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

Job Responsibilities: A) Project Management Undertake on-going referencing and literature reviews and provide strategic inputs to projects at all stages Evaluate methods under consideration by conducting literature survey (incl. regulatory guidelines, pharmacopeia guidelines, publicly available research, etc.) Identify initial cell-lines/ anti-body requirement based on method(s) identified Conduct lab experiments for bio-assay/ immuno-assay development and optimization Conduct lab experiments to qualify the method for reproducibility Prepare/provide inputs for the preparation of necessary documents like Method development report, Method qualification protocol and report. Method validation protocol and report, Standard Analytical Procedures (SAP), Method transfer protocol and report. Ensure tech-transfer by demonstrating process to plant operators (in lab premises) Observe process in plant and resolve any queries that may arise (post-transfer) B) Bio-assay/Impurity assay (HCP and HCDNA) /Binding ELISA assay/SPR assay/BET Method development, qualification and transfer Conduct regular analysis for non-GMP and non- release batches (not transferred to plant) - support other labs by stability testing samples provided by them Prepare and share detailed reports with the relevant labs upon completion of the tests Conduct Bioassay, HCP, HCDNA, Protein A ELISA, SPR, Binding assay and BET method development/qualification and routine analysis (C) Other tests and routine processes Conduct / guide RAs for conduct of regular analysis for non-GMP and non-release batches (not transferred to plant) - Support other labs by stability testing samples provided by them tests as requested. Prepare/review and share detailed reports with the relevant labs upon completion of the tests Conduct/ guide RAs for conduct of method development/qualification and routine analysis Review protocols and reports provided by CRO (based on expertise) Coordinate CRO with ADA assays, Antibody generation, purification and biotinylating activity for in-house HCP method. (D) Materials and equipment management Procure and maintain inventory of cell-lines/anti-bodies/ consumables/ equipment: Share details of requirements with purchase team Engage in technical discussions with vendors to identify and recommend suitable ones to lab head and Supply Chain Raise PR for purchase Oversee Check materials upon receipt and store them as per set-norms (freeze in case of cell-lines) Track and maintain inventory in order to control and manage short-falls and damage Maintain inventory-logs and intimate superiors in case of short-falls and damage Manage cell-culturing and sub-culturing process: Prepare cell-banks (by freezing cell-lines) for storage Passage cells (remove vials from these banks) as per testing need Calibrate select lab-equipment on regular basis to facilitate use Ensure scheduled and break-down maintenance by coordinating with vendors/ maintenance team ( E) Regulatory and compliance Accurately capture all lab experiments in raw- data and lab-notebooks (incl. electronic data- capture) in real-time on an on-going basis. Adhere to regulatory, SOPs and safety guidelines for all processes. Ensure timely closure of regulatory queries by conducting and documenting lab experiments. Ensure data integrity in all respects Compile and Review all project-related documents created during lab activity on a regular basis Prepare/ modify SOPs by gauging work ability of the processes/practices in timely manner (F ) Business (people & budgets) planning, continuity and improvement Conduct SOP and induction trainings for subordinates Provide timely and relevant inputs for the preparation of capex budget Identify and implement continuous improvement initiatives to enhance process efficiency Take initiative to provide time and inputs (based on expertise/interest) to other on-going projects (G) Learning and improvement Attend all mandatory trainings Take initiative to provide inputs (based on expertise/interest) to other on-going projects Take initiatives for self-development and update self on recent developments in own area of work Take initiative to train fresh RAs upon induction or guide them with select lab processes (basis expertise) (F) Quality Compliance Initiate change control for New instrument IQ/OQ/PQ/CSV of new instrument. GDP Compliance Compliance related to internal and external audits

What you will do - This role intends to recruit a talent who will seat on the divisional team and will have responsibilities for making testing efforts and goals a success working with local and global test lab Drive consistency in terms divisional procedures, be an active contributor in making development/verification testing a success. Responsible for sign off on key deliverable from testing/test lab perspective. Example: protocols, reports etc Ensure continual improvement in capability building , quality, delivering higher value services. Learn and contribute In making overall R&D process efficient by bringing predictability in terms of plan, execution, budgeting of development/verification testing. Act as a technical mentor for the project team to resolve the technical challenges. Analytical problem solvers; Dedicated achievers; Curious learners; Goal-oriented developers Conduct technology exploration and influence application in the business. Good understanding of Project Management concepts/approaches & Effectively communicate intent, progress and challenges of projects What you will need- Required- B. Tech / B.E / M. Tech / M.S. Mechanical; Minimum Experience10years and maximum 15 years. Minimum 5 years in similar role of product development/product testing Solid 3D CAD modelling skills (Creo). Experience on designing & development of machined/forged/cast components; manufacturing process with focus on DFM & DFA methodology; mechanical design engineering principles. Preferred- Proven Expertise in Material Selection Knowledge (materials specific to medical devices). Good knowledge of current industry standards for product development and risk control practices; designing of jigs & fixtures, inspection methods; GD&T principles and application. Know-how of tolerance stack-up, DFMEA, Risk analysis. Should have expertise on developing verification and validation methods.

Conduct Extractables & Leachable studies Operate LC-MS/MS, GC-MS/MS, UHPLC, GC-FID Method development, validation & data interpretation Ensure GLP, NABL, 21 CFR Part 11 compliance Exp. in PFAS, BPA, Nitrosamines preferred MSc/M.Pharm/Biotech required

Role & responsibilities 1. Development of Analytical methods. 2. Validation of Analytical methods. 3. Preparing analytical method development reports. 4. Literature survey for existing analytical methods. 5. Carry out literature survey by establishing the strategies. 6. Maintenance of FDA department. 7. Coordinating various development activities in FDA laboratory. 8. Maintenance of reference standard, working standards and their standardization. 9. Co-ordinating the activities in Chemical and Instrumentation. 10. Analytical Method Development and handling of Troubleshooting. Preferred candidate profile M.Sc. - Analytical / Organic Chemistry Candidate from Vadodara or nearby location preferred

Candidates should have good hands on Experience on HPLC, GC, Stability, Wet Lab, RM Sampling & Analysis, Documentation, Standardization of Karl fisher Titrator. Responsible for Calibration of Instruments. Can handle QMS & AMV activities Required Candidate profile Preferred immediate Joiners. USFDA preferable. Interested candidate can share CV on sachin.kapte@enaltec.com Mob.8976826875

Role & responsibilities Execute Analytical method Validation activities of drug substances (API) by using HPLC,GC and Spectroscopic techniques as per regulatory guidelines Execution and coordination for Analytical method transfer activities of drug substances(API) Calibration of the Analytical instruments as per the master calibration schedule. Preparation and review of analytical protocols and reports (Analytical Method Validation). Handling of Laboratory investigations like OOS,OOT,Incidents,deviation etc

About The Role Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Basic Minimum Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Education/Experience: A masters degree in Pharmaceutical/Analytical Chemistry Experience level : 0"“2 years of Analytical testing of Pharmaceutical Raw Material (e.g. ROI, LOD, pH, KF, etc) and GMP experience preferred. Additional Information Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience Strong Math Skills Logical Thinking, Good Reasoning Ability Motivation to excel Coaching/mentoring of peers

Roles: Manage Execution: Coordinate onsite IoT implementation and commissioning for DigitalPaani projects. Plan & Track: Develop detailed project plans, monitor progress (e.g., via Jira), and ensure timely delivery. Solve Problems: Support onsite teams to overcome hurdles and keep projects within budget. Requirements: Automation Experience: Skilled in PLCs, sensors, wiring, and electrical panel management. Organized & Practical: Strong at planning, documentation, and onsite execution. Industry Fit: Water industry experience is a plus; large-site execution is ideal but not required.

Aragen Life Sciences is seeking an HPLC expert for the position of Analytical Research Scientist to execute method development & validations focused on the API of new chemical entities (NCEs) and generics. The ideal candidate should possess a strong understanding of the fundamentals of analytical chemistry and HPLC combined with expertise in method development and validation based on sound scientific principles.

Principal task: Analytical Method Development by HPLC for all Project. Review the analytical method development data, validation study data and method transfer protocol and reports. Calibration of HPLC system. To maintain GLP/GDP in working environment. Preparation of analytical data and submit for review. Analytical Method Development and Validation. Responsibilities: Calibration of HPLC’s as per SOP and maintenance of HPLC Systems. Maintaining record for all analytical reports by entering all the data in raw data note book and timely release of analytical reports. Preparation & Review of analytical method validation protocol and report as per the current regulatory requirement. As per Protocol, perform the Analytical method validation of RS, Assay and Chiral for KSM, Intermediate and Finish product of compendia and non-compendia compound. Preparation & Review of Protocol & report of analytical method transfer report. Maintain records for all analytical reports by entering all the data and timely release the analytical reports to concern department.

Knowledge on how to develop the LCMS / HPLC suitable method from the GCMS method.Preferable to handling of LC-HRMS instrument and technical knowledge on E & L studies.Method development for GTIs and Nitrosamines by LCMS.Collect the literatures.

Serves as lead engineer on mid- to large size projects. Provides specialized technical input to studies and design for staff's specific area of expertise. Approves and signs off on work. Provides technical expertise for studies and design efforts. Presents complex technical solutions to clients. Performs quality control reviews of work developed by others. Participates in development of technical proposals. Provides estimates for the engineering budget and schedule to meet requirements on large projects.

Responsibilities: Responsible for Documentation work in QC Department Candidate must have Experience of HPLC , GC & Wet Analysis. Shall maintained all records related to manufacturing Overall looking after the complete filling, packing activities and Procurement of the packing material. To ensure the compliance of safety Requirement Cleanliness Hygiene and Environment in Working Areas. Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity. Required Skills: Team player Good in communication Required Qualification: - B.Sc/M.Sc - Chemistry

Responsibilities: To follow Good Laboratory Practices. Carry out routine analysis & Ensure documents pertaining to day to day analysis. Calibrate instrument used for analysis as per SOP and maintain its record. Method Transfer Activity. Should have experience of handling and calibration of GC, HPLC, KF, UV, Viscometer, Potentiometer, Tintometer, PH Meter etc. Various analyticals methods development and wet analysis along with related documentation. Required Skills Must be excellent in written and spoken English; Net savvy and adept at computer skills. Good in communication. Required Qualification : - B.Sc/M.Sc - Chemistry

Responsibilities: Responsible for Documentation work in QC Department Candidate must have knowledge of HPLC/GC. Responsible for manufacturing the batch as per MOM or BMR. Shall maintained all records related to manufacturing Overall looking after the complete filling, packing activities and Procurement of the packing material. To ensure the compliance of safety Requirement Cleanliness Hygiene and Environment in Working Areas. Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity. Required Skills: Must be excellent in written and spoken English; net savvy and adept at computer skills Attention for detail Team player Good in communication Required Qualification : - B.Pharm/B.Sc/M.Sc - Chemistry

Position: Pre-Clinical Designation: Research Associate Job Location: Dholka, Gujarat 1. Study Sample Analysis- Clinical studies 2. Method Development and Method Validation - Preparation of STP And MVP 3. Coordinate with QA & QC department for timely completion of Projects reports 4. Preparation of SOP and method development and method validation documents 5. Maintaining GLP & ensure 100% compliance

Role & responsibilities 1) Responsible for Laboratory execution of analytical activities on daily basis and ensuring compliance to the Safety and quality system as per cGMP. 2) Responsible for Laboratory execution of instrument calibration, stability analysis, WRS preparation/Qualification and for procurement of reference standard etc. 3) Responsible for maintaining stock of working reference standards and chemicals required routinely for raw material analysis. 4) Review and release of finished product, inprocess, intermediates, raw material, reaction monitoring results. 5) Responsible for Laboratory execution of analytical method validation/Verification and Method Transfer activites. 6) Coordination for reagents and volumetric solutions preparation, standardization and maintenance. 7) Coordination for maintaining analytical columns of HPLC, GC, IC and spare parts of instruments and Equipments. 8) Coordination of AMC / CMC of analytical laboratory instruments and its calibration. 9) Coordination for disposal of retained analytical samples of raw material, packing material, inprocess and stability samples. 10) Preparation, revision, review and checking of Raw material, inprocess, intermediates, reaction monitoring and finished products specifications and test procedure and departmental SOPs. 11) Planning and execution to review, checking of IQ, OQ and PQ documents of instruments and equipment. 12) Prepare and Review of certificate of analysis (COA) for finished products. 13) Responsible for investigation of incidents and Deviations in coordination with internal and cross functional team 14) Complying EHS promotional activities and complying EHS statutory requirements of the analytical department. 15) Handling of the ICP-MS/ ICP-OES, Ion Chromatography, GC-MS, UPLC,ION Meter and commissioning experience of the product and new Laboratory setup. Job specification: Experience : 6-10 Years Qualification : M.Sc Analytical Chemistry or M.Sc (Chemistry with large industrial experience in analytical method development and structure elucidation.)

Conduct analysis of pharmaceutical products using HPLC. Develop & validate analytical methods. Documentation & Reporting. Calibration & maintenance of analytical instruments. Participate in regulatory inspections and audits, Required Candidate profile Experience of Pharma companies is mandatory. Should be aware of QMS related to QC. It is on the rolls of Cotecna Life Sciences. Share resume on nilesh.kadam@geochem.net.in or call on 9870476784.

1. Develop, validate, and optimize analytical methods for raw materials, intermediates, and finished products. 2. Perform stability studies, impurity profiling, and release testing in line with ICH and regulatory guidelines. 3. Prepare comprehensive documentation, including method development reports and validation protocols. 4. Collaborate with formulation scientists to support product development and scale-up. 5. Troubleshoot analytical methods and instrumentation, ensuring efficient lab operations. 6. Ensure compliance with GMP, GLP, and regulatory standards within ADL.

Role & responsibilities Handling of Analytical Method validation of Assay and dissolution as per ICH Guidelines. Responsible for the Analysis of Finished products as per STP. Responsible for the Qualification and Maintenance of Working Standards. Responsible for sending of samples to external laboratory and receiving of reports. Maintenance of records / documents for external laboratory services. Dissolution: Carrying out different Media study with compilation of results. Regular Stability Analysis: Well versed with handling of regular Stability samples analysis. Operation and regular maintenance of stability chambers. Documentation: Good knowledge on GLP, GDP, CGMP and maintenance of records, usage logbooks. Preparation of Standard testing procedure for API, In process and finished products, Responsible for report preparation after completion of the analysis. Responsible for generating COAs for working standards and finished products. Responsible for Protocol based studies. OPERATION AND CALIBRATION OF THE FOLLOWING INSTRUMENTS: Knowledge on HPLC with Empower 2 and 3 Software. (UV/PDA) Knowledge on UV-Visible Spectrometer. Knowledge on Dissolution Tester. Knowledge on Operation and Maintenance NOTE: Immediate joiners pereferable