Designation | Sr. Executive or DM for Clinical trial GMP supplies |
Job Description | 1. Implement a fully integrated Good Clinical Practice program and provide leadership in order to assure regulatory compliance 2. Planning, preparation, review and approval of regulatory submissions, protocols, Investigator Brochures 3. Ensuring immaculate planning and execution of clinical studies 4. Build systems and procedures that are recommended by ICH/GCP or local regulatory systems 5. Preparation of Clinical Trial Application for Regulatory Agency Approval 6. Safety review of individual patient laboratory reports generated by central laboratories 7. Handling of Quality Management System and Environmental health and safety system and documenting the same 8.Implementation of Applicable regulatory standards in the country where clinical studies are to be conducted |
Desired Profile |
|
Experience | 6 - 10 Years |
Industry Type | Pharma/ Biotech/Clinical Research |
Role | QA/QC Mgr |
Functional Area | Production, Maintenance, Quality |
Education | UG - B.Pharma - Pharmacy,B.Sc - Any Specialization, Bio-Chemistry, General PG - M.Pharma - Pharmacy,M.Sc - Any Specialization, Bio-Chemistry, Other |
Compensation: | Best in the Industry |
Location | Bengaluru/Bangalore |
Keywords | Clinical Trail GMP Supplies, Quality Assurance |
Contact | ramitha.ravindran@biocon.com Biocon Limited |
Website | http://www.biocon.com/ |
Tuesday, August 17, 2010
Sr. Executive or DM for Clinical trial GMP supplies
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