Executive Quality Assurance- Clinical Trails Information

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IPCA Laboratories Ltd

For more than 60 years, Ipca has been partnering healthcare globally in over 110 countries and in markets as diverse as Africa, Asia, Australia, Europe and the US. Ipca is a fully-integrated Indian pharmaceutical company manufacturing over 350 formulations and 80 APIs for various therapeutic segments. We are one of the world's largest manufacturers and suppliers of over a dozen APIs. These are produced right from the basic stage at manufacturing facilities endorsed by the world's most disce... Read More

Address	142 AB, Kandivli Industrial Estate Ltd., Kandivli (West) Mumbai Maharashtra India
Website	www.ipcalabs.com
Holding	No Holding Details

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Executive Quality Assurance- Clinical Trails

Check patient visits and relevant documents daily to ensure that visits schedule does not deviate To perform final check of study documents including protocol, IB, and CRF for clinical and BA/BE studies To draft SOP, whenever required. To train new joinees on SOP and maintain relevant records To ensure compliance to SOP for day to day activities To perform review of site visit reports To perform QC check of EC submission, DCGI submission documents To check the AE details to be sent to pharmacovigilance department to ensure correct reporting To perform QC check of investigational products and CT supplies to be sent to the site To perform QC check of initiation documents for BA/BE and clinical studies To keep a track of payments made to the investigators and other vendors To audit clinical trials and BA/BE studies To prepare and submit monthly status for BA/BE and clinical studies. To ensure that all the projects are running smoothly. Identify the hurdles, perform root-cause analysis and proposesolutions Salary:INR 2,50,000 - 4,00,000 P.A Industry:Pharma / Biotech / Clinical Research Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology Role Category:R&D Role:Clinical Research Manager