Sr. Executive or DM for Clinical trial GMP supplies

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	Should have relevant experience in Clinical trial GMP supplies Should have good documentation skills
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/

Posted in: B.Pharmacy,B.Sc,Bangalore,Clinical Research,M.Pharmacy,M.Sc,Quality Assurance