Documentation assistant jobs in Dholka

 ...Daily Calibration, and maintain log of equipment. Method Development and method validation and study sample analysis as per ICH M10 guidelines. Operation, maintenance and Calibration of LCMS Documentation as per Bio analytical SOPs and ICH M10 guidelines. Data & Report review... 

 ...sample analysis. Perform the analytical method verification / validation as per protocol. Analytical method transfer to QC Laboratory. Documentation as per the GLP requirement. Trouble shooting during day to day analysis with proper instrument care. Perform dissolution... 

 ...Domestic/ROW, Injectable, P2P and others 4) Sample preparation and system setup for GC work 5) Analytical method transfer to QC Lab 6) Document work ,Reporting work and GLP activities 7) Ensure Gas cylinders' stock and Lab chemical stock 8) Cleaning and Maintenance of... 

 ...and standard test procedures for ANDA, Export and Domestic Markets Principal tasks & responsibilities: 1. Preparation of new product documents and routine revision of raw material specifications and standard test procedures for Export, regulatory agency and Domestic market 2... 

 ...Position Summary: The Assistant Vice President (AVP) Project Management will lead and oversee end-to-end project activities across a...  ...and governance processes. - Maintain and communicate project documentation, including timelines, risk registers, meeting minutes, and status... 

 ...development and delivery of allotted sterile formulations and any other assigned project as per agreed timelines and budget Completion of document preparation and formulation activities to support pre-clinical, clinical supplies and technology transfer of developed product... 

 ...batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, Hold time study protocol/ report, stability study protocol/report, Process... 

 ...of various laboratory animals like Rat, Micek, Rabbit, and Guinea pigs. 3. Conducting of pharmacological evaluation of various pharmaceutical products. 4. SOP preparation and documentation as per GLP regulation. 5. Maintaining facility for regulatory and sponsor's audit.... 

1. Act as TICO officer for receiving, handling and issuing of vehicle / reference/ test for pre clinical studies. 2. Maintaining document of test item control. 3. Communicate with the sponsor for TIDS, COA, and discrepancies about test material receipt, label and other issues... 

 ...of all type of batches Design and conduct stability and compatibility studies Meeting product development timelines Preparation of documents like PDR, BMR, regulatory response documents and stability protocols Active role in selection of formulation and data interpretation... 

 ...analytical method verification for API and Finished products as per pharmacopoeia and regulatory requirements. 4) Facilitate smooth and documented method transfer to the Quality Control (QC) lab, including training, protocol preparation, and data review. 5) Perform exhibit batch... 

 ...responses for various regulated & less regulated markets. - Evaluation of process and Route of synthesis. - Collection and compilation of documents to prepare Regulatory submission and customers. - Review STP's, Change controls of unit I & unit -II, AMV, Impurity profile and... 

 ...system 3) LC-MASS analysis support to synthetic laboratories and Ankleshwar plant 4) Calibration of HPLC and UPLC system with proper documentation 5) To maintain GLP in working environment Responsibilities: 1) Preparation of new Analytical method validation protocol and report... 

 ...cleanliness of the area/section. - Procurements of materials for conduct of experimental activity in laboratory. - Request for controlled documents and maintain accountability as per in-house SOPs - To co-operate during internal, RQA & sponsor audits of study plans, studies, data... 

 .... Recording of refrigerator and laboratory temperature. Maintenance of log book and preventive maintenance check for instruments. Documentation as per GLP. Archiving of dry & wet materials Allied responsibility: Analysis of samples for Biochemistry, Hematology, Coagulation... 

 ...LCMSMS Operation Maintenance and Calibration 2. Method Development, Method Validation and Project Study sample analysis as per ICH M10 Guidelines and in house SOPs 3. Documentation as per GDP, GLP and in house SOPs 4. Daily Performance activity of Bio analytical Equipments... 

 ...ways to streamline and/or improve processes – Operational Excellence. Participate in safety studies like HAZOP and preparation of documents like HAZOP report & HIRA. Design of the manufacturing facility and providing technical support to project team during execution &... 

 ...of Daily performance check of Bio analytical equipments and external and internal calibration data 3. SOP preparation, Report Preparation, Report review, STP,MVP,BSP review 4. To perform System audit, sponsor audit and Regulatory audit 5. Documentation as per GLP and GDP... 

1. To develop Stable & Bioequivalent solid oral products for US, EU, ROW and Domestic Markets 2. Technology transfer of developed products to plant level, this includes all TTD-related works. 3. To collect and compile all data and submit to respective regulatory agencies. 4....

New Product Development of Domestic, ROW and EU markets Revision of Products of Domestic, ROW and EU markets as per Requirements of various stake holders PM selection, Machinability as per existing Automization of the pack Cost competitive pack development Monitoring of Stability...

Major Purpose of the Job: - To develop cost effective and robust process of API. - To manage lab activity as per current GLP guideline. Principal Tasks and Responsibilities: - To develop chemical process which is having least hazardous chemicals and cost effective process of...

 ...Manages active medium projects with minimal assistance from Management. Resolves project issues and resource constraints within the team and with moderate assistance. Facilitates positive team member interactions and manages conflict with minimal assistance. Establishes/practices... 

Principal task: - Preparation of specification and standard test procedure for Intermediates, KSM, In-Process check , Raw materials & API (Finish product) for DMF & NDMF Projects. - To maintain and follow GLP/GDP in working environment. Responsibilities: - Preparation of Specification...

Principal task: Analytical Method Development by HPLC for all Project. Review the analytical method development data, validation study data and method transfer protocol and reports. Calibration of HPLC system. To maintain GLP/GDP in working environment. Preparation of analytical...

Major Purpose of the Job: - Analytical Method Development by HPLC for all Project. - Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. - Calibration of HPLC system. - To maintain GLP in working...

1. Method Verification of new HPLC Method for all stages of a new molecule as well as a modified old method as per regulatory requirement. 2. Calibration of HPLC as per SOP and maintenance of HPLC system. 3. Maintaining all analytical records by entering correct details in reports...

Major Purpose of the Job: - To develop cost effective and robust process of API. - To conduct lab activity as per current GLP guideline. Principal Tasks and Responsibilities: - To develop safe and cost effective chemical process for API in lab. - To check the proof of concept...

1) Maintain GLP in the laboratory as per regulatory requirement. 2) Issuance and Maintain the records of reference standards, working standards and impurities standards 3) Issuance and Maintain the records of HPLC columns 4) Calibration of all laboratory instrument/Equipment...

Major Purpose of the Job: - To develop cost effective and robust process of API. - To manage lab activity as per current GLP guideline. Principal Tasks and Responsibilities: 1. To develop chemical process which is having least hazardous chemicals and cost effective process ...