11 Glp Compliance Jobs

Key Responsibilities: Plan, perform, and report acute toxicology studies in alignment with regulatory and scientific standards. Assist in the preparation of SOPs, protocols, and reports for toxicology studies. Participate in GLP (Good Laboratory Practices) and AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) compliance activities. Conduct literature searches to support study planning and scientific understanding. Ensure maintenance of animal house facilities and related documentation as per GLP and AAALAC norms. Assist and collaborate with Study Directors (SD) and Test Coordinators (TC) for planning, initiation, and execution of studies. Perform test item admin...

As the leader of the DQA department, your role is to ensure the implementation of CGMP rules and regulations in Research & Development. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and communicating with R&D, ARD, QA, and Regu...

Role & responsibilities 1.Stability Studies Management: Planning and management stability studies, Comparative Stability and Forced Degradation (FDS) Studies, Reference product age related studies of all the projects. Compilation of stability data, interpretation, and data trending. To review the data, related DRS and LNBs etc. 2. Drafting / review / approval of operational SOP, LP, SLP and Stability Protocols, Summary Sheets, Reports as required. 3. Planning and management of the IRS: Planning and management for establishment of internal reference standards. Management of IRS stability studies, issuance, compilation and trending the retrospective data of the established internal standards. ...

Conduct analysis of various pharmaceutical materials, including: In-process samples Intermediates Raw materials Packing materials Finished products Stability study samples Hold time study samples Process validation samples Cleaning samples Vendor development samples Any other analysis allocated by the team leader. Release analytical results with thorough and accurate documentation. Ensure all analyses are performed in compliance with Good Laboratory Practices (GLP). Ensure all raw analytical data is documented electronically and in real-time. Initiate, complete, and file daily analysis reports meticulously. Immediately report any abnormal results, incidents, deviations, or discrepancies to t...

Analyze various pharmaceutical materials including: In-process samples Intermediates Raw materials Packing materials Finished products Stability study samples Hold time study samples Process validation samples Cleaning samples Vendor development samples Any other analysis allocated by the team leader. Release analytical results with proper documentation. Take responsibility for ensuring the quality and purity of pharmaceutical products using High-Performance Liquid Chromatography (HPLC) techniques. Prepare samples for HPLC analysis according to established Standard Operating Procedures (SOPs) and specifications. Analyze HPLC data, interpret results, and generate reports documenting test resu...

As a Senior QC Manager in Noida Phase-2, you will be responsible for overseeing quality control activities in the laboratory and production environment. With 7 to 10 years of experience, you will utilize your expertise in material analysis, lab testing, and product quality management to ensure compliance with regulatory standards and meet customer requirements. Your key responsibilities will include performing material testing and inspection to ensure quality compliance, identifying defects in materials and collaborating with procurement for corrective actions, maintaining accurate records for quality control processes, preparing Certificates of Analysis (COA) for products, and overseeing th...

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 productivity improvem...

You will be responsible Analytical method development and validation of injectable, Inhalationsand Nasal products. You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field. You will be responsible to execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team. You will be responsible for analytical method development fo...

Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeho...

Role Responsibilities: Operate HPLC, ELISA Reader, and microscopy instruments Perform colorimetric and spectrophotometric assays Maintain GLP-compliant documentation and lab practices Support QC testing in biochemical and hematology assays Key Deliverables: Accurate analytical test reports 21 CFR-compliant chromatography data Routine calibration and maintenance logs QC records supporting GMP batch release

Role Responsibilities: Operate HPLC, ELISA Reader, and microscopy instruments Perform colorimetric and spectrophotometric assays Maintain GLP-compliant documentation and lab practices Support QC testing in biochemical and hematology assays Key Deliverables: Accurate analytical test reports 21 CFR-compliant chromatography data Routine calibration and maintenance logs QC records supporting GMP batch release