362 Method Validation Jobs - Page 11

The selected candidate will work directly in a private setup focused on stock and commodity trding in a residential setup with free accommodation. This role is ideal for someone who is looking for a long-term, stable opportunity. Free meal Cafeteria Food allowance Shift allowance Over time allowance House rent allowance Flexi working Accessible workspace Assistive technologies Sports for women

Candidate must have experience from chemical manufactiring industry.

Find endless opportunities to solve our clients toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Strategy & Consulting, Global Network I Areas of Work: Cost takeout, earnings before interest, taxes, depreciation, and amortization, (EBITDA) improvement in Direct Spend | Level:Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad| Years of Exp:4-8 years for Consultant, 1-4 years for Analyst Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, Accenture Strategy and Consulting is the right place for you to explore limitless possibilities. As a part of our Cost & Productivity Reinvention (C&PR) practice, you will help organizations reimagine and transform their supply chains for tomorrow"”with a positive impact on the business, society and the planet. Together, let's innovate, build competitive advantage, improve business, and societal outcomes, in an ever-changing, ever-challenging world. Help us make supply chains work better, faster, and be more resilient, with the following initiatives: Be a part of the Accenture Cost & Productivity Reinvention (C&PR) practice that has expertise in delivering projects with quantified savings in the indirect and direct categories. Support and lead Cost & Productivity Reinvention (C&PR) engagements, including sourcing for direct, indirect categories, conducting spend analyses, market intelligence, identifying cost reduction or process improvement opportunities, data analytics, so on. Take the lead on all digital sourcing and technology initiatives. Work towards Accentures Cost & Productivity Reinvention (C&PR) approach for EBITDA improvement including direct material cost transformation, indirect material cost transformation, logistics cost transformation, manufacturing efficiency improvement & cost transformation conduct data analytics across financial data and operational data. Deliver cost transformation engagements for clients across industries. Bring your best skills forward to excel in the role: Strong analytics skills driven by the next wave digital and technology initiatives Ability to solve complex business problems and deliver client delight Excellent communication, interpersonal and presentation skills Cross-cultural competence with an ability to thrive in a dynamic environment Read more about us. Recent Blogs Qualifications Your experience counts! MBA from Tier-1 B School 1-4 years of experience for an Analyst and 4-8 years of experience for a Consultant, across direct materials, manufacturing, logistics, market intelligence, EBITDA improvement programs , Business case development, Strategy formulation, Spend analysis across financial and operational data Experience in a consulting firm and global exposure is desirable. Retail, Healthcare, CG&S, Automotive, Industrial, Logistics industry experience would be preferred. Hands-on experience with analytical tools such as MS Excel, PowerBI, Alteryx would be an added advantage What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Global Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Global Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world.For more information visit https://www.accenture.com/us-en/Careers/global-network At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team

Provide remote analytical support to PPL sites, including review of analytical data and preparation of documents such as specifications, test methods, and protocols. Upload documents for review in ENSURE and initiate QMS elements in TrackWise/eDMS. Prepare and review stability protocols and reports, and perform stability data trending and analysis B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Review of analytical data generated in the analytical lab (QC/AS) including but not limited to Cleaning verification data, IPC , raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner. Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc Knowledge in analytical data review in Empower/ Chromeleon / Open-Lab / Lab-Notebooks / LIMS / QMS module. Analytical Method Development and Documentation: Create and revise working test methods in compliance with compendia requirements and laboratory practices to support analytical testing. Change Request Forms (CRF) Management: Routinely initiate and manage Change Request Forms via the TrackWise system, including updates to product specifications and Certificates of Analysis (COA). Data Trending and Out-of-Trend (OOT) Analysis: Perform trend analysis of release testing data to identify OOT results. Develop, implement, and maintain procedures for trending and statistical data evaluation. External Data Review: Review analytical data generated by external laboratories to ensure compliance with specifications and quality standards. Share the review deficiencies with site team for further actions. Develop, revise, and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity . Conduct thorough Compendia reviews of USP (United States Pharmacopeia) monographs and ensure alignment with internal specifications and regulatory expectations. To participate and support site during customer audits and regulatory inspection. Lead and participate any other task assigned by HOD .

To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage. Performing qualification, periodic calibration, and maintenance of laboratory instruments. Maintain proper cleanliness, calibration, and qualification status of analytical instruments. Coordinate with warehouse and QA for sampling of incoming materials as per SOPs. Ensure proper labeling, storage, and disposal of samples and reference standards. Support internal, customer, and regulatory audits by providing required documentation and clarifications. Implement corrective and preventive actions (CAPA) as per audit observations. Additional Responsibilities: Participate in method validation, verification, and transfer activities as required. Assist in updating and reviewing SOPs, specifications, and analytical procedures. Contribute to continuous improvement initiatives in the QC department. Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor. Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

Role & responsibilities : Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables) Daily calibration of pH meters, balances etc. Stability sample management (loading & withdrawal as per stability plan) Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicable Hands-on experience of analytical instrumental techniques (HPLC with chromatographic software etc.) Assisting analytical method development/validation/method transfer activities, as per need Supporting other assigned lab responsibilities for GLP compliance Preferred candidate profile

Analysis of in-process, raw materials, intermediates API with expertise on HPLC and wet chemistry. To carry out analytical method development and method validation, in-process samples and finished products. To carry out analytical method transfer activity to QC. Trouble shooting of analytical instruments for difficulties faced during day-to-day operations. Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc. Literature Search for development of analytical methods. To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site Hands on experience on Instruments viz., Auto-titrator, HPLC and UV etc. Knowledge of regulatory requirements for different markets (US, EU, Canada etc.) Knowledge on ICH guidelines, forced degradation studies, impurity profile, etc. Your experience and qualifications M.Sc. / M. Pharm./ Ph.D. 4-8 Years relevant experience Sound knowledge of Chemistry and analytical method development, method validation and transfer, Instrumental method of analysis and logical approach for complex generic API. Teva s Equal Employment Opportunity Commitment

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 Your experience and qualifications M.Sc. Chemistry/B Tech (Chemical Engineer) with 1-5 years of experience in relevant industry and profil

We have opening for Formulation AR&D Department. Job Openings: 6 Nos Position : Research Analyst or Sr Research Analyst Handling Instruments like HPLC 1-5 Years Exp 2- 8 Yrs. Job Location: Pashamylaram - Patancheruv (Telangana) Salary : As Per Company Norms Qualification: Pharm or M.Sc. or M .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. Please share me update resume: careers@biophore.com Total Exp : Current CTC: Exp CTC: Notice Period: Current Designation:

Over see the development, implementation, and validation of analytical methods used for the testing of Active Pharmaceutical Ingredients (APIs) in compliance with internal standards, industry regulations, and customer requirements. The role requires leadership skills to manage a team, ensure compliance with good laboratory practices (GLP), and drive continuous improvement in method validation processes. This position also involves close collaboration with various cross-functional teams including R&D, Regulatory Affairs, and Quality Assurance.

Roles and Responsibilities Conduct quality control analysis of bulk drugs, APIs, and pharmaceutical products using techniques such as HPLC, GC, and method validation. Perform stability studies to ensure compliance with GMP guidelines. Calibrate instruments accurately and maintain records of instrument maintenance schedules. Ensure accurate documentation of test results, reports, and certificates of analysis. Collaborate with cross-functional teams to resolve quality issues. Only male candidates

Greeting from Biophore India pharmaceutical Pvt Ltd. Hiring for Formulation Analytical R&D Department. Job Openings: 6 Nos 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. Please Carry below documents: 1. Updated resume. 2. Last 3 months pay slips or bank statement 3. Offer letter or Increment letter from the present employer,4. Photocopies of all Education certificates Ref to Friends or colleagues.

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.