1074 Glp Jobs - Page 12

Responsible to prepare protocols ,reports, Sop's, review docs and analysis, methods development, verification validations for AET,MLT Sterility test& BET, follow GMP&GLP,SILUTION STUDY/microbial ingress study.

Study Personnel-Chemist/Sr. Chemist Department :- Chemistry (RC) Place of work :- Pune Office Reporting :- SD/Manager Qualifications :- M.Sc./B.Sc. in Chemistry Preferably Organic or Analytical Chemistry Experience :- Functional Responsibilities :- Administrative Responsibilities :- Oversee Operations of RC Dept. with its complete Scope with the help of Team and Facilities provided. And deliver as mentioned in Job Responsibilities Analyze the sample on HPLC-PDA, GC-ECD as per scope/requirement received in RC department. Extraction of samples using QUECHER s Extraction Procedure for Residue Analysis. Maintain the daily calibration of Balances pH meter. Monitoring recording environmental condi...

Study Personnel-Chemist/Sr. Chemist Department :- Chemistry (PC) Place of work :- Pune Office Reporting :- SD/Manager Qualifications :- M.Sc./B.Sc. in Chemistry Experience :- Functional Responsibilities :- Administrative Responsibilities :- Oversee Operations of PC Dept. with its complete Scope with the help of Team and Facilities provided. And deliver as mentioned in Job Responsibilities Analyse the sample as per scope/requirement received in PC department. Maintain the daily calibration of Balances pH meter. Monitoring recording environmental condition in the department. Maintaining consumables in department. Monitoring and performing all equipments/instruments maintenance and calibrations...

Primary Job Function To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes e...

Our vision is to transform how the world uses information to enrich life for all . Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR58146 GEL Supervisor Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods...

Role & responsibilities Food Testing - Instrumentation Sample analysis & Method Validations under the guidance of Section In-Charge Understanding the complete requirement of the method before initiating the analysis Maintenance of all logbooks of equipment being used in section Working reference standard preparation Maintenance of records for working reference standards with their logbooks under the supervision of Section In-Charge Glassware calibration Intermediate checks of equipment under the supervision of Section In-Charge Specific responsibility of the assigned instrument (AAS/ICP-MS, GCMS-MS, LCMS-MS, IRMS) Calculating uncertainty of measurement for different parameters Responsible fo...

Job Purpose To ensure the accuracy, completeness, and compliance of all Quality Control documentation and test results as per current Good Laboratory Practices (cGLP), regulatory guidelines, and internal SOPs before final release or submission. Key Responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation rep...

Role & responsibilities Sample Management and outside lab testing. Sterility Testing. Operation and Qualification/Validation/Performance verification of equipment and instruments. Environmental Monitoring of clean rooms and its trend. Report any OOS to the superior as when observed. Particulate Matter Test and compilation of all the testing reports. Batch release activity. Bacterial Endotoxin Test of In process samples and release drug product. Temperature, RH and differential pressure monitoring. Responsible for training and analyst qualification as per requirements. Analytical Method Validation and other validation studies. Isolation and identification of in-house isolates. Pyrogen and abn...

As a QC Chemist with 5 to 8 years of experience at Sinterx Pharma Private Limited, your role involves leading and executing complex analytical testing of API intermediates to ensure compliance with quality standards and regulatory guidelines. You will conduct advanced testing, review analytical data, support investigations, mentor junior analysts, and contribute to continual improvement initiatives. Collaboration with Quality Assurance, Production, and R&D teams is essential to maintain product quality throughout the production lifecycle. **Key Responsibilities:** - Perform routine and non-routine analysis of raw materials, intermediates, and in-process samples using validated methods and in...

Job Title: Calibration & Validation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11). Key Responsibilities: De...

Eurofins is the world leading Food Testing laboratory group, deploying a comprehensive range of state-of-the-art analytical techniques in order to support its clients' increasingly stringent quality and safety standards. We are present in India as Eurofins Analytical Services India Pvt Ltd and provide a comprehensive and one-stop testing service to businesses and organizations involved in food and feed processing, Agro products, Export, Hospitality and Retail chains. About The Role Responsible to develop, implement and be responsible for the production plan for their respective departments. To deliver timely and accurate analysis of samples to meet customer commitments. Be responsible for re...

The ADL Chemist will be responsible for method development, validation, &routine analysis of raw materials, intermediates, &finished products. Role ensures compliance with quality & regulatory standards while supporting R&D and manufacturing Required Candidate profile Perform analytical method development and method validation for raw materials, intermediates,& finished products.Conduct routine analysis using HPLC, GC, UV, FTIR, and other analytical instruments.

Role & responsibilities - Responsible for IPQC testing for Albumin and IVIG testing on routine batches. - Preparation of DRS, Log book entry and related documentation to be make online. - Support to prepare Albumin and IVIG drug substance and Drug product testing and its release with all documents. - Handling of QC instrument as HPLC/GC for routine sample and other instrumentation maintenance. - Preparation of STP/SOP/DRS for QC documentation on routine basis. - Responsible for IPQC, DS, DP and stability sample testing on routine batches. - Involved in Analytical method validation. - Handle the instrument and Equipment for routine use as well as calibration and qualification.

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Utility Manager should have a strong understanding of Pharmaceutical Projects for all dosage forms including Sterile & Oncology. Should have a firm hands on experience into the Design of both Clean Utilities from water pre-treatment, final treatment, Storage and Distribution as per various guidelines and Black utilities like sizing and selection of Chillers, Boilers, Cooling tower, Air compressor, etc. Pipe & Component selection, sizing and generating BOM and costing. He will lead a team of engineers for ensuring the delivery of all pharma projects. Well versed with relevant guidelines like cGMP, ISPE, USFDA, ASME, GSP, GLP, ISO etc. Will be independently dealing with the Client, Vendors and...

As a Manager - Quality at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, your role will involve the following responsibilities: - Handling of Change control - Handling of Deviation and CAPA management system - Handling of Internal and external audits - Sound knowledge about Equipment and Utility qualification - Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. - Should have experience of regulatory audits The company, Dishman Carbogen Amcis Limited, operates in the General business unit and is committed to maintaining high quality standards in accordance with regulatory requirements.,

As a Laboratory Operations professional at Piramal Pharma Solutions (PPS) in Morpeth, United Kingdom, your role involves the following critical tasks: - Preparation of samples and associated reagents, performing basic analysis accurately and on time - Gathering, generating, analyzing, and interpreting data - Organizing and planning your work efficiently - Preparing samples, reagents, and equipment required for analysis - Ensuring the laboratory is well stocked and resourced - Performing a variety of analytical testing using wet chemical and instrumental techniques - Conducting routine equipment maintenance and calibration - Writing and reviewing SOPs, sampling and testing procedures, analyti...

Title: Manager - Quality Custom Field 2: 2490 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Handling of Change control, Handling of Deviation and CAPA management system, Handling of Internal and external audits, Sound knowledge about Equipment and Utilty qualifcation, Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. Should have experience of regulatory audits. Job Segment: Quality Manager, Law, CAPA, Manager, Quality, Legal, Management

lead&plan projects-pellets/mups,meet TPP, timelines,budget-FRD(FBC,RMG,Coating,Nano),interpret ARD results,delegate & monitor teams, Ensure compliance: MFR,scale-up,stability protocols,PDRs,SOPs,GMP,SHE Technical discussions-DQA, ARD, Marketing, Required Candidate profile FRD pellets/modified release, QbD,cGMPs, GLPs, expertise in process and formulation optimization,tech transfer&scale-up -FBC,RMG,coating,extrusion,nanotech, DIPO qualification, validation, spec review

develop/optimise pellets/mups - FRD(FBC,RMG,Coating,Nano),interpret ARD results,delegate & monitor teams, enforce GLP&GDPs, prep/review: MFR,scale-up,exhibit & stability protocols,PDRs, SOPs cross-function coordination, meet TPP, timelines,budget. Required Candidate profile FRD pellets/modified release, QbD,cGMPs, GLPs, expertise in process and formulation optimization,tech transfer&scale-up -FBC,RMG,coating,extrusion,nanotech, DIPO qualification, validation, spec review

Requisition for Executive for the implementation and monitoring of GLP in TIC. Skills Required : Good Laboratory Practice, Quality Assurance, MS Office Package, Communication Skills Roles and Responsibilities : Preparation of documents related to applying GLP (Good Laboratory Practices). Ensure the upkeep and maintenance of the laboratory by implementing GLP. Ensure compliance with GLP standards. Logbook management, sample management, SOP management, and other document management related to GLP. Any other work related to Quality assurance assigned by the manager. GLP-trained person or experience working in GLP labs. Must have good verbal and written skills.

1. Having adequate knowledge of Sampling, Testing of Raw material, Packing Material, Finish Product, Validation and Stability samples. 2. Having adequate knowledge of Laboratory Instruments and equipment s Calibration, Maintenance/External calibration. 3. Having adequate knowledge of Preparation of laboratory chemicals, Reagents, test solution, and Volumetric solution. 4. Having adequate knowledge of Reference, Chemical and Working standard management i.e., Working Standard qualification and support in working standard management. 5. Having adequate knowledge of Data entry in SAP. 6. Having adequate knowledge of operation and trouble shoot of HPLC/GC/AAS/UV/IR/Dissolution and other QC analyt...

6-to-8-year HVAC and Clean room design experience in Pharma, Biopharma, API facilities, well conversant with global standards for HVAC as well as Pharmaceuticals to implement in HVAC design like ASHRAE, SMACNA, ISO, ISPE, GMP, GLP, UKMHRA etc. BMS -EMS knowledge will be added advantage. Environment Sustainability knowledge. About the Role Key Responsibilities: Develop, evaluate and optimize HVAC system designs for pharmaceutical projects. Lead HVAC design projects from concept to completion, ensuring timely delivery within budget. Design HVAC systems that maximize energy efficiency and comply with sustainability standards. Design and review of Sustainability projects. Ensure designs meet loc...

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legisl...

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725