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Tuesday, August 17, 2010

Sr. Executive or DM for Clinical trial GMP supplies

DesignationSr. Executive or DM for Clinical trial GMP supplies
Job Description1. 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
Experience6 - 10 Years
Industry TypePharma/ Biotech/Clinical Research
RoleQA/QC Mgr
Functional AreaProduction, Maintenance, Quality
EducationUG - 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
KeywordsClinical Trail GMP Supplies, Quality Assurance
Biocon Limited 


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