Medical Writer - Narratives
Job Overview: Responsible for preparation and review of clinical documents such as patient safety narratives and clinical study report (CSR) appendices. Responsible for preparing lower complexity docu
Find Pharma, Biotech, Clinical Research & Medical Jobs on Bioksha
Job Overview: Responsible for preparation and review of clinical documents such as patient safety narratives and clinical study report (CSR) appendices. Responsible for preparing lower complexity docu
Summary of Responsibilities: Based on forecast models, manage the resources to meet or exceed business Service Level Agreements. Supervise, Mentor, Evaluate and aid in staff development, career develo
Job Overview: Responsibility for delivering EDC design and specifications within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data. Document and mai
Take complete responsibility for API manufacturing operations during the assigned shift. Execute production batches as per approved BMRs, SOPs, and validated process parameters. Monitor and control
Execute API manufacturing processes as per approved Batch Manufacturing Records (BMRs), SOPs, and standard procedures. Monitor and control manufacturing operations such as charging, reaction, heating
Job description: Core responsibility related to GLP: -Anesthesia/euthanasia of laboratory animals as per SOP -Blood collection preparation -Collection of blood from laboratory animals as per SOP a
JOB RESPONSIBILITIES 1) Analytical Method development and report preparation on LCMS/MS (for Nitrosamine impurities, azido impurities etc.) 2) Analytical methods validation and report preparation o
Major Purpose of the Job : Responsible for small volume injection manufacturing related activities. • To take part in lyophilized related activities as per SOP. Principal task and responsibilities:
JOB RESPONSIBILITIES • Review of Literature summary report, patent summary report and development protocols. • New product development, Planning and Resource allocation for Domestic, ROW, US, EU, CM
Job description:- To ensure that GDP &cGMP practices shall be followed from the premises to their section. To follow the all respective SOPs & BMR procedure in the department during operation. Ensu
Lead and maintain the site Quality Management System in compliance with cGMP, ICH, WHO, USFDA, EU GMP, and other applicable regulatory requirements. Review and approve SOPs, specifications, protocols
"• Working in tablet granulation area as an operator and responsible for whole Granulation activity. • Operation & Cleaning of the respective Granulation machine hand over by shift in charge or any s
"•Working in tablet granulation area as an operator and responsible for whole Granulation activity. •Operation & Cleaning of the respective Granulation machine hand over by shift in charge or any sup
Role Objective / Major Purpose of the Job Directly manages daily shop-floor execution, operator allocation, and immediate batch manufacturing targets. Focus on maximizing machinery yield, minimizing
To perform In-process Quality Assurance for the process / products being manufactured and packed in Main Pharma Block (Tablet / Capsule). To ensure Quality and cGMP compliance of the products being m
Execute API manufacturing batches as per approved Batch Manufacturing Records (BMRs) and SOPs. Monitor manufacturing processes such as charging, reaction, heating/cooling, extraction, filtration, cen
Perform analysis of API, intermediates, raw materials, solvents, and finished products using HPLC, GC, UV, and other analytical techniques. Execute routine and non-routine analysis as per approved ST
• Planning and Execution of all MMD-I & BPR preparation activity pertaining to Main Pharma Block, Cephalosporin Block, Penicillin Block & Rifampicin Block of Dholka, as well as Contract Manufacturing
Documentation: • To prepare SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice. • Ensure that all documents / records required for Regulato
Perform analysis of API, intermediates, raw materials, in-process and finished products as per approved specifications and SOPs. Handle and troubleshoot HPLC and GC instruments for routine and stabil
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