299 Method Validation Jobs - Page 10

Greeting from Biophore India pharmaceutical Pvt Ltd. Hiring for Formulation Analytical R&D Department. Position : Research Analyst or Sr. Research Analyst Exp 2 - 7 Yrs. Job Location: Pashamylaram - Patancheruv -Hyderabad. Salary : As Per Company Norms Qualification: M .Pharma or M Sc or B.Pharm Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Ref to Friends or colleagues.

Method development and validation of Genotoxic impurities/ nitroso amine impurities/NDSRIs in pharmaceutical products/ substances by LC-MS/MS. Development of MS compatible methods for the HPLC RS methods for the identification of unknown peaks by LC-MS Development of MS compatible methods for the identification of degradation impurities and unknown impurities

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Role & responsibilities 1. generate sample run list from the laboratory's information management system (LIMS). 2. Set up the LCMS system for sample analysis and run samples according to defined methods. Documents activity according to company sops. 3. Process and review instrument data and document all observations according to company sops. 4. Update data into Laboratory's LIMS. 5. Prepare reagents required for routine analysis. 6. Write or contribute to the review of written SOPs in the laboratory. 7. Understand and comply with all safety procedures applicable to the type of work performed. 8. Work with all laboratory personnel to maintain a safe and clean working environment. 9. Work with the QAU and Safety Officer to address and correct issues arising from quality assurance or safety audits. Preferred candidate profile M.SC/M PHARMA ANY GRADUATE/POST GRADUATE

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring

Develop analytical methods for biochemistry samples using GC-MS, LC-MS, and other relevant techniques. method validation, optimization, and transfer to ensure accuracy and reliability of results. data analysis, and reporting in accordance .

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Physical R&D Researcher I - TAPI Date: May 2, 2025 Location: Greater Noida, India, 201306 Company: Teva Pharmaceuticals Job Id: 61663 Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industrys broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service. Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market. Your experience and qualifications MSc Chemistry / B Tech (Chemical Engineer) with 1-5 years of experience in relevant industry and profile How you ll spend your day Perform Polymorph screening as per guideline. Follow cGMP Documentation and EHS compliance at workplace Perform Virtual and Experimental Screen and evaluate all literature that relates to solid-state issues. Screen new forms by performing stress tests and File ASAP new forms in patent application Analyze laboratory samples by XRD, DSC, TGA and other characterization techniques. Assess kinetic stability and interconversions and produce scheme of all polymorphic transitions Produce solubility curves of different polymorphs and assess thermodynamic stability relationships Develop detection methods to assess polymorphic purity and monitor in the laboratory samples Support the development of the crystallization process with full characterization Monitoring stability and physical properties of micronized/milled materials Perform calibration, method development, method validation, and troubleshooting using various instruments like PXRD, DSC, TGA and Particle size analyzer Knowledge of various regulatory guidelines w.r.t. method development, product development, and documentation.

Qualifications: Educational Background: M.Sc. in Chemistry, Pharmaceutical Chemistry, or related field. M.Pharm in Pharmaceutical Analysis is a plus. Experience: 38 years of experience in analytical development within the pharmaceutical industry. Technical Skills: Proficiency in analytical techniques such as HPLC, UV-Vis spectroscopy, and dissolution testing. Familiarity with method validation and stability study protocols. Soft Skills: Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Ability to work independently and in a team-oriented environment.

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

Role & responsibilities 1. Performing Stability analysis, Method transfer and Method Validation. 2. Develop formulations for solid oral dosage forms (Tablets, Capsules) with expertise in compression, granulation, coating, OSD, and formulation development. 3. Conduct production monitoring activities to ensure compliance with quality standards. Desired Candidate Profile 4. Strong understanding of tablets, capsules, compression, granulation, coating processes; knowledge of OSD technology an added advantage. 5. Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports. 6. To carry out analytical method development, method validation and testing of impurities in finished products on LCMS/MS and GCMS/MS 7. RM (HPLC)GCTesting 5. Preparation, review of departmental SOPs and training of analysts. 6. Calibration and validation of instruments equipments. 7. Review and maintenance of all logbooks in the department. 8. Procurement of columns, chemicals/ reagents/ solvents and standards for Stability analysis, Method Transfer and Method Validation.

Qualification - Msc Chemistry - 3- 6 Yrs Experience Experience of GC / HPLC Preferred . Experience in Zydus : Min.12 months Job Responsibilities o Handling of HPLC system /GC o Up-keep of all Instrument Usage Log,Inward Register, Training Records etc. o Usage of SOPs, Specifications and STPfor Inprocess, Intermediate, FiniAsh Product, Recovered Solvents, and CleaningSample. o Handling of LIMS for Receiving ofsample along with Intimation Slip for Inprocess, Intermediate, Finish Product,Recovered Solvents, Cleaning Sample and outside sample etc. and testing as pertheir Specification and STP. o To follow the GMP, Safety norms andadhere to companys policy. o Attending Training classes i.e.Internal and External program as per schedule. Usage of SOPs, Specificationsand STP for Inprocess, Intermediate, Finish Product, Recovered Solvents, andCleaning Sample. o Receiving of sample along withIntimation Slip for Inprocess, Intermediate, Finish Product, RecoveredSolvents, Cleaning Sample and outside sample etc. and testing as per theirSpecification and STP. o After analysing and writinganalytical data, hander over the raw data to senior person for review. o Timely reporting of results andinvestigation of any deviation, OOS, incident. Maintain house-keeping and GLPin working area. o Additional Job activities endorsed bySuperior.

Responsible to prepare analytical method development, development validation, method transfer protocol and reports. Perform F&D Trial sample analysis, Wet analysis and stability sample analysis with proper data complication. Operation of machine and instrument like HPLC(Make = Shimadzu,Thermo Software =Chromeleon, Lab solution,LC Solution), UV spectrometer (Make = Shimadzu, Software = Lab Solution), IR (Make = Shimadzu, Software = Lab Solution) Dissolution apparatuses, Liquid partical counter and Karl fischer for water content. Perform instrument calibration as per respective SOP daily pH meter calibration and balance verification.

Literature survey for assigned projects. Analysis of innovator samples as and when provided. Analysis of development batches. Analysis of stability batches. Writing of experiments online in Laboratory Notebooks (LNB) with all details. Processing of raw data and calculations after completion of each analysis. Analytical method development of drug products. Analytical method verifications for drug substances. Preparation of Specifications-STP for Raw materials and finished products.

Laxmi Organic Industries Limited. We are looking for candidates interested in Technical Associate-Quality for Dahej. Job Title: Technical Associate-Quality Department: Quality Control/ Quality Assurance Location: Dahej. Job Purpose Analysis of Raw material, water sample, Packing material In-process & Finished products Role and Responsibilities Operational: Daily analysis of water, In-process, Daily Finished product sampling and analysis Daily sampling of RM, In-process, Finished product. Dispatch of finished product dispatches of tanker, drum, bags sampling and analysis. Counter samples storage, retrieval, instruments cleaning Detection of abnormalities during analysis and report it to the concerned authority. Raw Material inspection, sampling and analysis. Result recording in SAP. HPLC and GC Data storage Packing material sampling and analysis. Checking of certificate of analysis Report any near miss /incident or any non-compliance To Support Various ISO, Process safety and Responsible Care Initiatives Responsible to compete any other assignment given by the senior. Deviation reporting and recording OOS reporting and recording. Required Knowledge (of any equipment / Tools and techniques / Software) GC, HPLC, UV, Titrimetric, Karl Fischer, Potentiometer, QESH Education Essential: M.Sc in Chemistry Preferred: M.Sc in Chemistry (Analytical, Organic, Inorganic) Experience Essential: 2-4 years in chemical industry If you are interested, kindly share your updated cv on below email id. Email Id: siddhi.pathak@laxmi.com Telephone No: 9125652023

Role & responsibilities 1. Performing Stability analysis, Method transfer and Method Validation. 2. Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports. 3. To carry out analytical method development, method validation and testing of impurities in finished products on LCMS/MS and GCMS/MS 4. FG (HPLC) 5. Preparation, review of departmental SOPs and training of analysts. 6. Calibration and validation of instruments equipments. 7. Review and maintenance of all logbooks in the department. 8. Procurement of columns, chemicals/ reagents/ solvents and standards for Stability analysis, Method Transfer and Method Validation.

Role & responsibilities Execution of immunoassay method development based on ELISA platform. Method validation and study sample analysis for the estimation of antibodies in biological matrices for various vaccine projects using various immuno-analytical techniques. Handle multiple projects, work in a team, in co-ordination with team members, ensure smooth execution of immunology and clinical serology activities. Responsible for execution of assays / experiments, and recording of data in appropriate documents. Responsible for data analysis and communication of experimental results from time to time to supervisor or concerned personnel. Ensure that all instruments in immunology and clinical serology laboratory are maintained as per the schedule and calibrated on time. Preparation of SOPs, LCRs, GCRs, analytical plans and analytical reports etc. based on the requirement. Perform the activities in clinical serology laboratory in compliance with GCLP and approved SOPs. Follow appropriate safety practices using proper PPEs like apron, goggles and gloves etc. while performing laboratory activities. Take directions from the supervisor and work in a collaborative environment and being a team member mind set. Preferred candidate profile

For day to day sample extractions & instrument (LCMS/MS - GCMS/MS) sequencing Roles and Responsibilities Testing of various agriculture and food products for chemical and nutritional testing by standard and in-house methods Hands on expireance in Proximate Analysis Operating the lab instruments like pH meter, weighing balance, incubator, GCMS/MS & LCMS/MS, UPLC Preparation of standard solutions Daily maintenance of lab equipment. Following good laboratory practices Following disposal process for samples & solutions as per SOP. Accurate analysis and interpretation of test results Maintenance of laboratory documents and records Validation of methods and calibration/verification of instruments Ensuring purity and validity of CRMs Conduct sensory evaluations of food samples

Expertise in ICP-OES and ICP-MS techniques. Expertise in Ion Chromatography working knowledge of various chromatography and spectroscopy techniques, including HPLC GC. independently managed development tasks, consistently delivering within timelines. Required Candidate profile Ideal Candidate should Be M.sc With 5 + Years of Experience in ADL Department Must Have Experience in Method Development & Method Validation. Must Have Experience in Ion Chromatography

Operation and Calibration of Analytical Balance Method Development Method Validation Scale up Batch Analysis, Investigating Analysis HPLC Analysis Instruments handling

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. 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 M.Pharm (Pharmaceutical Analysis) / M.Sc Chemistry Additional Information Experience level : 0 - 2 years in Bio/Pharmaceutical Analysis 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

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

Maintenance and use of GC FID To test and analyze proximate parameters like UV parameters, Analysis of Fatty acids Maintaining samples before and after analysis Maintaining the CRM Method verification & validation SOP preparation Interpretation of the results. Qualifications 6-8 years experience of working in food testing laboratory. Proficient in analytical techniques of wet chemistry, proximate analysis, watr analysis, Allergen testing, Meaurement of Uncertanity calculation. Greaduate Bsc/Msc 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.),

Responsible for managing & operating all testing Labs & achieving revenue from all labs as defined by the management Responsible for implementation of quality policy throughout the labs Reviewing the contracts for new test methods as per the company norms Effective coordination with internal teams and other operational department or labs Ensures all lab staff have adequate resources to perform all aspects of work required Ensures all lab staff are adequately trained to safely perform all required job functions and that competency records are maintained Ensures corporate policy & procedures in the laboratory Provides employee motivation and champions the quality system, including, calibrations, quality assurance, training and lab quality system. Maintains an open door policy and communicates with lab staff to promote empowerment and accountability Obtains and maintains an in-depth knowledge of local market requirements Understands customer requirements and organizes lab procedures, schedules and staffing to provide for meeting/exceeding same Handles required disciplinary matters in a fair and consistent manner and maintains open communication with the all the departments Represents Spectro by appearance and conduct with strong ethical attitude Ensures laboratory practices meet or exceed company policy and industry standards Reads, understands and enforces the company quality and safety measures May on occasion be required to perform the duties of the lab supervisor and/or lab technicians Establishes or adjusts work schedules to meet testing requirements and control costs Markets actively for new clients Other duties as may be assigned by higher management Qualifications M.Sc/Phd/B.Tech Minimum 10 to 15 years of experience in managing Lab operations from NABL accredited testing company or testing labs

To Prepare sample for the determination of heavy metals, micro minerals and minerals in Food and Agriculture samples as per ISO, IS and Customer specific requirements adopting test methods ISO, AOAC and IS methods using Microwave digestor. Maintenance of standard Reference Materials, Chemicals, Reagents and Glassware used in the laboratory. Responsible for all the instruments related to Metal analysis. Maintaining samples; before, during and after analysis. Qualifications 3-4 years experience of working in food testing laboratory. Proficient in handling ICP-MS and method validation for heavy metals analysis Graduate 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.),

Job description: Leadership role to manage team size of 10+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Managing multiple instruments (LC-MSMS, GC-MSMS, ICP-MS, IC etc.) Method development experience in LC-MSMS, GC-MSMS and ICPMS instrument Preparation and Implementation of SOPs related to E& L , 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 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 Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab. Skills Required: For M.Sc, 16-18 years of Discovery Analytical R&D experience and for PhD, 14-16 years of 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 Qualifications Qualification M.Sc./PhD/Postdoc Additional Information Specialization Analytical Chemistry/Organic Chemistry, Department E&L Experience (years) 16 - 20