QA Executive | Bhagalpur

Supports the Regulatory Operations Team in the creation of regulatory submissions in their delivery of regulatory submission components ? Assist regulatory in preparation, formatting, and internal approval of QA documents for new product. ? Coordination with related Official Departments or authorities. i.e. Health Authorities worldwide ? Create and updating of related SOPs, cooperate with related departments including monitor the implementation of SOPs ? Monitor the regulatory status for variation worldwide and coordinate with staff in other countries ? Update GRA table and archiving correspondence to Health Authorities. ? Develop regulatory network between different departments and other countries ? Prepare annual product quality report, product-related quality (PQRS / APRs) report ? Coordinate with other group/department and related third parties in part of product quality and statistical process control ? Statistical analysis using Minitab or equivalent tools ? Commercial diploma or equivalent ? Minimum 2 years experience in Regulatory Affairs ? Microsoft office and regulatory data base ? Good command in English ? Ability to handle several tasks
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