Personal Information
Organization / Workplace
Hyderabad Area, India India
Occupation
Specialist Quality operations, Regulatory Affairs
Industry
Medical / Health Care / Pharmaceuticals
About
Technical Summary
-Gap Analysis, compilation of Module 3 for CEPs, Variations, Renewals, RFI's and also Clinical Trial Authorisations.
- Worked for CMC, Change Control Coordinator (reviewing, authorizing) Regulatory Affairs Report for Annual Product Reviews/Product Quality Reviews (APQRs)-Regulatory Compliance.
- HoE on ARIS Register, SAP B.O, Share Point etc.Basic project management tasks, defining and delivering project metrics & its assessments to clients regularly.
- Handling of Changes in AGILE system to evaluate execute and close the changes.
- Preparation of Volume Reports and HA tracking activities.Understand the supplychain processes.
- Writing Regulatory strategy & Pre Mark...
Contact Details
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