945 Method Validation Jobs - Page 5

Job Summary We are seeking an experienced Analytical Specialist specializing in Mass Spectrometry to develop sensitive and robust methods for quantifying genotoxic impurities in drug substances and products. This role involves method development, validation, troubleshooting, and resolving method-related issues. Your expertise in Mass Spectrometry will be crucial in creating accurate impurity profiles through comprehensive analysis. Roles & Responsibilities You will be responsible for developing sensitive and robust methods to quantify genotoxic impurities in drug substance and products. This involves selecting appropriate quantitation modes, validating methods, and transferring them to QC si...

Jubilant Biosys is looking for Senior Research Associate and Research Scientist for Preparative HPLC and NMR roles Location: Jubilant Biosys - Bengaluru Department: AR&D Skill: Preparative HPLC and NMR Experience: 8-15 Years Qualification: MSc Analytical Chemistry / MSc Chemistry/Organic/Industrial/General Immediate Joiners will be preferred

Role & responsibilities Analytical testing: Conduct a wide range of tests, including biochemical assays (Spectroscopic), Immunochemical assay (ELISA, Western blotting), DNA quantification (RT-PCR) and various chromatographic techniques (e.g., SEC, RP, SDS-PAGE,). Method development and validation: Assisting in or leading the development, optimization, and validation/qualification of analytical methods for the characterization of biosimilars and other large molecules. Biosimilarity studies : Perform studies to compare the biosimilar candidate to the reference product, focusing on physicochemical, functional, and safety properties. Statistical Data analysis and reporting: Processing and interp...

Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate pro...

Monitor product and process quality, conduct inspections and audits, document findings, ensure SOP compliance, report deviations, support corrective actions, coordinate with production teams, and maintain quality records accurately.

Responsibilities: Collaborate with cross-functional teams on method development & optimization Ensure compliance with regulatory requirements through QMS implementation Conduct regular audits & inspections Food allowance Health insurance Annual bonus Provident fund

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. What You Will Achieve In this role, you will: Ensure training records are updated and correctly filed to reflect current testing ...

Role & responsibilities : Assay Development & Execution: Perform method development, method qualification, and sample analysis for SPR, BLI, cell-based assays, and ELISA. Independently design, execute, and troubleshoot assay protocols. Ensure timely completion of all analytical activities with high scientific quality. Documentation & Reporting: Prepare and review technical documents including dMOA, MQP, MQR, MTP , and other assay-related reports. Maintain accurate, complete, and compliant records following Good Documentation Practices (GDP) . Contribute to data interpretation, documentation, and presentation of results. Equipment Management: Perform routine preventive maintenance (PM) and ca...

Relocation Assistance Offered Within Country Job Number #170434 - Mumbai, Maharashtra, India Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name! Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core valuesCaring, Inclusive, and Courageouswe foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future ...

Role & responsibilities Main Role: 1. To perform Stability analysis. 2. Maintenance of operating instruments / equipment. 3. To maintain the assigned Laboratory workplace, instruments and equipment etc. 4. To adhere Good Laboratory Practices (GLP), Good Documentation Practices (GDP), relevant regulatory guidelines and PAL procedure. Preferred candidate profile Detailed description of Main Roles and Responsibilities: 1. Responsible for handling , operating and maintaining HPLC / UV and related instruments to ensure optimal performance. 2. Adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), relevant regulatory guidelines and PAL procedure. 3. Performing stability ...

ql-editor "> Research Scientist The Analyst will be responsible for supporting bioanalytical studies within the clinical research domain, with a focus on method development, method validation, and routine sample analysis. The role requires strong technical expertise and adherence to established quality and regulatory standards. The selected candidate will actively contribute to the execution of bioanalytical projects in full compliance with GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and all applicable regulatory guidelines. The Analysts will additionally be responsible for providing supervisory support, guiding junior team members, and taking on broader project leadershi...

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of ho...

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of ho...

Job Track Description: Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of ho...

Role & responsibilities : Reviewing, verifying, and processing of all technical documents for accuracy before compilation or submission of dossiers as per USFDA & PEPFAR requirements. Review and regulatory compliance of Initial ANDA Documents like Trade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Size and Shape, Elemental iron, Residual solvent, Elemental impurity and Exactable and Leachable impurity, Specifications [API and Finished drug Product), Master Formula (with respect to Bio-waiver), Stability Protocol, Labeling Information, Product development Report, Method Validation Report, BMR and BPR etc. Participate and represent as regulatory team in meetings (Level 1 and 2 ...

Role Overview: As a Quality Specialist II at Teva Pharmaceuticals, you will play a crucial role in ensuring that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner. Your responsibilities will include compiling high-quality APRs/PQRs, liaising with third-party contract manufacturers for data collection, recommending actions for continuous improvement in product quality, and participating in various quality management systems activities. Key Responsibilities: - Compile high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at different sites - Retrieve data from Quality and regulat...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Primary Responsibility: Pre-sales demonstration with applications for high end technology (LCMS and LCMSMS) Post-Sales training to customer trouble shooting at customer place as well as in Technical Centre to support LSMS sales team (30-50%) Technical Training sessions for Customer as well as internal customers. Help to maintain and increase product usage and support sales efforts through technical presentations and product demonstration. Develop and maintain positive relationship with customers. Accompany Sales Representatives on sales calls in customer laboratories to provide technical and applications assista...

Responsible for lab functions-QC,Analytical & Application, RM/PM/Inprocess/FP testing & Analysis, Checking & review of QC SOPs/STPs, cGMP, Handling/Calibration/troubleshooting of Lab instruments, system Devlp,Co-ordn with Prod/SCM/R&D/QA Dept,MIS etc Required Candidate profile M.Sc./M.Pharm with 11 to 16 yrs exp in API industry. Should have sound exp of handling HPLC, GC, KF, AT, LOD tester, MP/BP,Polarimeter etc. System knowledge like IMS, GMP, NABL RC, SAP, ISO is must.

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- Qualychrome Research Labs, H.No .5-5-35/128, plot no.177, near Venkateswara Swamy temple, Prashanti Nagar, Kukatpally, Hyderabad, Telangana on Saturday 06-12-2025. 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, w...

Role & responsibilities : HPLC monitoring and handling Inspection and testing Equipment operation Perform analytical testing Operate and maintain instruments Handle data and documentation Support stability studies Report and investigate Out of Specification (OOS), Out of Trend (OOT) results, and deviations. Manage lab supplies Ensure compliance Environmental monitoring Testing and analysis Strong knowledge of microbiology principles and testing methodologies Proficiency with microbiology laboratory equipment.

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Saturday 06-12-2025. 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...

Ensure compliance for audit of QC as per USFDA, EU GMP GLP in QC Calibration Review of all QC Standards & Procedures regarding Calibration, Raw and Packing Material, Finished products Excellent communication & coordination Required Candidate profile B.Pharma / M.Pharma/ M.Sc with 7 to 20 years experience as QC reviewer, ensuring compliance as per USFDA & EU GMP standards Capable to Review of all QC procedures Willing to relocate to Jaipur

Role & Responsibilities Lead development of device coatings with and without drug-eluting capability for medical applications. Formulate and optimize polymer matrices for device coating and for controlled release from device coatings. Design and synthesize sodium-based and acid etching solutions for surface treatment and functionalization. Develop surface modifying reagents tailored for L-605, Nitinol, and other medical-grade alloys. Oversee wet chemistry lab setup including equipment specification, layout, and compliance setup. Establish lab SOPs and ensure strict adherence to EH&S and GLP standards. Plan and execute in vitro drug release studies, stability protocols, and surface characteri...

Role & responsibilities We are looking fresher candidate Preferred candidate profile Male candidate

Role & responsibilities Routine analysis using HPLC and GC independently Method execution, system suitability, and troubleshooting Analysis of RM/Intermediates/Finished Products Calibration & maintenance of HPLC/GC instruments Review of chromatographic data, audit readiness, and documentation Preparation of COA, STPs, and analytical records Ensuring strict compliance to cGMP and data integrity Preferred candidate profile 3+ years QC experience in an API manufacturing unit Strong hands-on expertise with HPLC & GC (operation, troubleshooting, calibration) Good understanding of ICH Q2 , cGMP, and data integrity principles Experience in routine analysis of RM/Intermediates/Finished Products Abil...