706 Glp Jobs - Page 14

Essential Functions: Participate in project planning and distribution of R&D tasks and responsibilities. Monitor and evaluate process verification schedules, plant verification batches, and prepare corresponding reports. Compare yield and quality trends of R&D verification batches and plant validation batches. Prepare, review, and interpret characterization reports for working standards, key starting materials (KSMs), and related substances. Prepare and verify documentation related to R&D process verification and validation batches. Support in plant-scale investigations and troubleshoot issues in coordination with plant and QA teams. Ensure timely submission of R&D and validation samples to ...

Essential Functions: Perform routine analysis of raw materials, intermediates, APIs, in-process samples, stability samples, and other laboratory samples as per approved specifications and methods. Carry out sampling of raw materials and packing materials in accordance with SOPs. Ensure accurate, timely, and online entry of analytical results in LIMS and relevant documentation systems. Prepare approved/rejected labels for raw materials, intermediates, and packing materials based on analysis outcomes. Conduct daily verification/calibration of analytical instruments (e.g., pH meter, balance) as per approved methods. Maintain analytical instruments in good condition and ensure logbook entries ar...

Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT. Key Responsibilities: - Execution of process scale up experiments, documentation and process improvements to support manufacturing. - Process transfer and execution of tech. transfer with help of BBM. - Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report. - Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Al...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Long Description 1. Perform characterization of peptides , nucleic acids-based (oligonucleotides) or other injectable drug products using High Resolution Mass Spectrometry (LC-HRMS) . Experience with QToF/Orbitrap instruments and Ion Mobility will be preferred. Additional experience in Fluorescence, particle size analysis (DLS), and other relevant techniques (e. g. SEC-MALS) are desirable. 2. Analyze and interpret LC-MS and MS/MS data for impurity profiling and characterization. Solve problems and implement new research methods through literature search, coordinate with cross-functional teams (formulation, QA, QC, regulatory, etc. ), application specialists, etc. to complete analytical tasks...

Job Description Planning /Analysis (Routine and stability and QBD analysis) of ongoing projects by performing analysis of various tests (e. g. Dissolution, assay, Related substances test, or as per requirement) within given Time. Analytical Method development as per current SOP/guideline wherever required. Regulatory query/Plant Query related analysis for different products. To follow Good Laboratories practice while working. Documentation and compliance and review of data generated on all analytical activities as per the GLP/GMP norms and to keep working place neat and clean. Method transfer at plant. Method equivalency, method verification, pharmaceutical equivalency analysis of Pharmacope...

Division Department Sub Department 1 Job Purpose Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements Key Accountabilities (1/6) Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission Conduct extensive literature search Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTI s on different ...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for s...

Career Category Operations Job Description HOW MIGHT YOU DEFY IMAGINATION You ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goalsAt Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Qua...

Roles and Responsibilities Role Overview Lead the Quality Control (QC) laboratory operations Ensure compliance with cGMP , GLP , and regulatory standards (e.g., WHO, FDA) Supervise testing of raw materials, in-process samples, and finished products Oversee stability studies , method validation , and instrument calibration Managing team and work allocation Key Responsibilities Review and approve analytical reports , COAs , and SOPs Investigate OOS/OOT results and implement CAPA Coordinate with QA, Production, and Regulatory Affairs for product release Maintain audit readiness and data integrity

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control. Kindly Send CV to mail ID, jagpal.dewal@ipca.com vishal.rankham@ipca.com

Long Description 1. Perform characterization of peptides , nucleic acids-based (oligonucleotides) or other injectable drug products using High Resolution Mass Spectrometry (LC-HRMS) . Experience with QToF/Orbitrap instruments and Ion Mobility will be preferred. Additional experience in Fluorescence, particle size analysis (DLS), and other relevant techniques (e.g. SEC-MALS) are desirable. 2. Analyze and interpret LC-MS and MS/MS data for impurity profiling and characterization. Solve problems and implement new research methods through literature search, coordinate with cross-functional teams (formulation, QA, QC, regulatory, etc.), application specialists, etc. to complete analytical tasks. ...

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 and maintain QC instruments, including HPLC, GC, UV, FTIR, Dissolution Apparatus, Melting Point Apparatus, Karl Fischer Apparatus, Auto Titration, Analytical Weighing Balance, Polarimeter, Disintegration Apparatus, pH Meter, etc. Perform analysis of in-process samples, validation, hold-time study, finished products, and stability samples as per relevant specifications. Conduct daily and monthly calibration of analytical balances in the instrumentation section. Maintain daily logs and ensure adherence to Good Laboratory Practices (GLP). Perform daily standardization of Karl Fischer reagent. Monitor and record daily temperature readings of the instrumentation ro...

1. Analysis of Bulk/Granules/Intermediate/Stability & F.G 2.Sample analysis and reporting according to DCAD/DPAD 3. Raw data filling & online reporting 4.Analysis of raw material & finished product sample by HPLC & GC 5.Analysis of sample by UV-VIS Spectrophotometer & dissolution test. Preferred candidate from Pharma OSD Formulation experience only.

We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation...

The Quality Assurance Manager (ISO/IEC 17025:2017) position requires a minimum of 5-7 years of experience and a Bachelors Degree (or higher) in Chemistry, Biochemistry, Food Science/Technology, Analytical Chemistry, Chemical Engineering, or related disciplines. The role is based in Bagru, Rajasthan. As the Quality Assurance Manager, your primary responsibility is to ensure the lab's Quality Management System (QMS) complies with ISO/IEC 17025:2017 and other regulatory requirements. This involves managing audits, maintaining lab safety and equipment, resolving customer complaints, and driving continuous improvement. Key Responsibilities: - Implement and maintain ISO/IEC 17025:2017 QMS and ensu...

You will be joining Sohan Healthcare Private Limited in Daund as a full-time QA Manager. In this role, you will be responsible for overseeing the quality assurance processes, conducting internal audits, ensuring compliance with regulatory requirements, managing quality control activities, and implementing quality improvement initiatives. Your expertise in Quality Assurance, Quality Control, and Regulatory Compliance will be utilized to uphold the highest standards of quality at Sohan Healthcare Private Limited. To excel in this role, you should possess experience in conducting internal audits and implementing quality improvement initiatives. An in-depth understanding of GMP, GLP, and other r...

The R&D Executive at PTC - MORAIYA will be responsible for performing analysis of Drug Product and Drug Substances for various test parameters according to product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. The role also involves compiling analytical results and preparing Method Development Reports. Additionally, the R&D Executive will be responsible for ensuring Good Laboratory Practices (GLP) aspects in the analytical laboratory. The ideal candidate should have 0 - 3 years of experience in a similar role.,

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

As a Clinical Quality Assurance professional at WPPL, you will play a crucial role in ensuring the establishment, implementation, and maintenance of processes required for the Quality Management System. Your responsibilities will include reporting on the performance of the quality system, planning and executing clinical activities, and conducting various audits across departments. You will be responsible for reviewing equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring compliance with relevant SOPs and guidelines. Additionally, you will review clinical data, pharmacokinetic analysis, statistical output, and statistical analysis ...