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Amneal Pharmaceuticals
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Asst. Manager / Deputy Manager - Regulatory Compliance
3-7 years
Ahmedabad
1 vacancy
Asst. Manager / Deputy Manager - Regulatory Compliance
Amneal Pharmaceuticals
posted 5d ago
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Flexible timing
Key skills for the job
Job Description
- Conduct periodic inventories and reports required by the Drug Enforcement Administration and various state reports. Submit the final reports to DEA Compliance Auditor in a timely manner. Compiles all daily submissions for controlled substance orders and verifies against the DEA 222 form and submits all Controlled Substance orders to DEA regulatory systems within the required 48 hours.
- Administrating in writing DEA documents which include, but are not limited to: Registration applications, renewals and updates. Drug code additions. Import and export permit application forms. Helps complete and/or distribute DEA 222 order forms for procurement of API, USP standards, RLDs, etc.
- Reviewing reports to ensure effective control measures and Compliance SOP guidelines are being followed at all facilities. Communicate all discrepancies to DEA Compliance Auditor.
- Conduct monthly audits of all controlled substance, maintain record keeping, inventory, and security systems to prevent diversion of controlled substance raw materials and finished products. With assistance from compliance auditor, oversee suspicious order monitoring process.
- Manage the destruction process by reviewing and compiling the documentation for destruction in adherence to the destruction schedule. of scheduled materials, waste or by products.
Employment Type: Full Time, Permanent
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