Aishwarya Singh
Asst. Manager | Drug enforcement Administration | QMS | Compliance | Healthcare Regulatory Professional | Global markets Regulatory Submissions | EU MDR,US FDA I STED Creation I Project management
- Role
- Assistant Manager at Amneal Pharmaceuticals
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Aishwarya Singh
Dedicated Regulatory Affairs and Compliance professional with experience spanning…
Experience
Assistant Manager
May 2025 — Present
Conduct periodic inventories and prepare reports required by the DEA and various state agencies, ensuring timely submission to the DEA Compliance Auditor.2. Compile and verify daily controlled substance orders against DEA Form and submit all orders to DEA regulatory systems within the required 48-hour timeframe.3. Prepare and manage DEA documentation, including:• Registration applications, renewals, and updates• Drug code additions• Import and export permit application forms4. Assist with DEA order forms for the procurement of APIs, USP standards, RLDs, and other controlled materials.5. Review compliance reports to ensure adherence to control measures and facility SOPs, and communicate any discrepancies to the DEA Compliance Auditor.6. Conduct monthly audits of all controlled substances, maintaining accurate records, inventories, and security systems to prevent diversion of raw materials and finished products.7. Support the suspicious order monitoring process in coordination with the DEA Compliance Auditor.8. Oversee the destruction process by reviewing and compiling documentation for the destruction of scheduled substances, waste, or by-products, in line with the approved destruction schedule.
Education
Poona College of Pharmacy, Pune
Mpharm, Drug regulatory affairs
2017 — 2019
Amravati University
Bachelor's degree, B.pharm
2013 — 2017
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