706 Glp Jobs - Page 24

Thermo Fisher is seeking a new colleague who is passionate about customer experience, is technologically savvy, and has a passion for the digitization of science. The vision of Digital Science Solutions is to make it easy for scientific customers to digitize their research, development, and manufacturing lab operations. The Technical Consultant will be responsible for providing guidance, support, and implementation services related to Digital Sciences Solutions products such as LIMS, ELN, LES, SDMS, and other enterprise applications. You will work closely with clients to understand their laboratory processes and requirements, design solutions, perform system implementation tasks, and provide...

Thermo Fisher is seeking a new colleague who is passionate about customer experience, is technologically savvy, and has a passion for the digitization of science. The vision of Digital Science Solutions is to make it easy for scientific customers to digitize their research, development, and manufacturing lab operations. The Technical Consultant will be responsible for providing guidance, support, and implementation services related to Digital Sciences Solutions products such as LIMS, ELN, LES, SDMS, and other enterprise applications. You will work closely with clients to understand their laboratory processes and requirements, design solutions, perform system implementation tasks, and provide...

Job Title: Nonclinical SEND Data Associate Introduction to role Are you ready to harness the power of data for growth? At AstraZeneca, we are seeking data operatives to provide technical expertise for SEND data from nonclinical studies. This role is crucial in meeting health authority requirements and maximizing the opportunities these data present. Join us and lead the way for a new breed of solutions-oriented regulators! Accountabilities: As a Nonclinical SEND Data Associate, you will provide support across nonclinical functional areas, promoting and enforcing the use of nonclinical data standards. You will maintain metadata libraries, review and assess the impact of newly released and upd...

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and obtain approvals from CDSCO i.e., FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e., Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN, i.e., Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with ...

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and valida...

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

Key Responsibilities Lead on-site Quality Control activities for agrochemical production at the plant. Ensure in-process and finished product quality meets regulatory and internal standards. Oversee sampling, testing, and analysis of raw materials, intermediates, and final products. Maintain calibration and performance of lab equipment (HPLC, GC, etc.). Prepare and manage documentation for audits, compliance, and certifications (ISO/GLP). Drive continuous improvements in plant QC practices and team efficiency. Qualifications 5-7 years of QC experience in a plant/factory setup within the agrochemical industry. Strong knowledge of analytical methods and safety protocols.

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for metho...

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for metho...

Career Category Information Systems Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE Role Description: This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated...

? Job Description: ? ? We are seeking for a motivated and detail-oriented QC Trainee / Executive to join our quality team. The ideal candidate will be responsible for supporting quality control operations in method development, routine analysis, and documentation for APIs and intermediates under development. ? ? Key Responsibilities: ? ? Perform sampling and testing of raw materials, intermediates, and finished products. ? ? Conduct instrumental analysis (HPLC, UV, IR, GC) as per approved methods. ? ? Prepare and maintain Certificates of Analysis (COAs), logbooks, and test records ? ? Maintain lab notebooks, data integrity, and QC documentation ? ? Support in creating analytical method to id...

? Job Description: ? ? We are looking for a skilled and proactive QA/QC professional with 2 5 years of experience to join our quality team. The candidate will be responsible for executing and overseeing quality assurance and quality control activities in compliance with regulatory and company standards. ? ? Key Responsibilities: ? ? Quality Control? ? Perform analytical testing of raw materials, in-process samples, and finished products. ? ? Operate, calibrate, and troubleshoot instruments such as HPLC, UV-Vis, GC, FTIR, and KF. ? ? Prepare and review analytical documentation including test reports, COAs, and calibration records. ? ? Guide and Mentor QC Executives / Trainees for analytical t...

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for metho...

Division Integrated Product Development Department Global Respiratory Sub Department 1 Respiratory -Formulations RD - DPI Job Purpose Execute the core method development activities and conduct analysis of routine as well as stability samples to finalize specifications and ensure timely delivery of product to unit. Key Accountabilities (1/6) Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Document and interpret the analytica...

Job Purpose: The QA Auditor is responsible for evaluating and ensuring compliance with applicable regulatory standards, including Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), across clinical research and laboratory operations. This role supports the organization's commitment to quality and regulatory integrity by conducting internal and external audits, identifying non-compliance, and driving corrective and preventive actions. The QA Auditor plays a critical role in maintaining high standards of data integrity, patient safety, and regulatory compliance, while supporting continuous quality improvement in alignment with international guidelines and sponsor expecta...

To execute sampling and analysis of Raw materials along with relevant laboratory documentation. To execute analysis of finished goods, In-process, packing materials and cleaning samples along with relevant laboratory documentation. Result reporting after completion of analysis & relevant documentation . Before starting an analysis, following points (but not limited to) must be checked: Check all the instruments on the equipment required for the analysis are in working condition and are in calibrated state. Checking and ensuring proper status labels after confirming availability of all the requirements (as applicable) for analysis such as approved control procedure, analytical protocol, refer...

Job Title: Study Monitor Support Specialist Introduction to role: Are you ready to dive into the world of non-clinical study monitoring? As a Study Monitor Support Specialist, youll play a pivotal role in supporting the Study Monitor group within Regulatory Toxicology and Safety Pharmacology. Your contributions will be vital in ensuring the smooth execution of studies that pave the way for groundbreaking medical advancements. Accountabilities: - Support the study monitoring of in vitro safety pharmacology (hERG) studies. - Assist NonClinical Toxicology Study Monitors with key study activities. - Provide essential support for external study monitor activities. - Maintain and update supporting...

Key Roles & Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, ...

Job Summary : Experienced QC professional with 8-10 years in pharmaceutical quality control and compliance. Responsible for preparing specifications, test methods, and maintaining GMP, GDP, and GLP standards. Supports regulatory affairs, handles deviations, OOS, and change controls, and reviews analytical reports. Proficient in SOP creation, method updates, and team training as per cGxP and regulatory guidelines. Responsibilities: Preparation and updating specifications and test methods to ensure compliance with statutory and company standards Preparation of specification for input materials, intermediates, active pharmaceutical ingredients, finished products and stability products to ensure...

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, de...

Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About the Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e. g. , analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc. ) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriat...

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

Literature survey for assigned projects. Analysis of innovator samples as and when provided. Preparation of test report against the Test request form received and compilation of results if necessary. Analytical method development of drug substances and drug products. Validation of drug products and verifications on activities for drug substances. To act as instrument in-charge for the allotted instruments and responsible for calibration and maintenance of the same. Carry out basic trouble shooting for instrument related issue, whenever required. ll Impart training with respect to instrument handling to junior colleagues. Preparation and checking ofMDR, MVR and MOA. Maintain GLP Activity in L...

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Method development & Validation ( HPLC /GC/ UV/ Potentiometer etc..) for both Solid orals and Injectables & Handling of all analytical instruments/ Equipments, SOPs prepation, SPEC and STPs prepation/ review,Stability samples analysis .