Qureos Mentor

Amneal Pharmaceuticals

<div>Description:
Coordinates investigations of suspicious orders with Amneal's DEA compliance and supply chain to prevent diversion. Assume other duties as assigned.Complies with all company policies and standards. Supervise Compliance Auditors while conducting other Amneal site internal on-site inspection of NJ and KY locations. 
 
Essential Functions:
<ul><li>Daily Supervision of the On-Site DEA Auditors, Sr. Auditors and Inventory Clerks. Review and evaluate job performance of direct reports and time management. Supervise the Suspicious Order Monitoring Program and it's daily operations/work conducted by subordinates.
</li><li>Supervise all transfers and acquisitions of controlled substances to ensure timely, accurate, and compliant transfers within Amneal registered facilities to include DEA Form-222s and invoices.
</li><li>Supervise periodic inventories and reports required by DEA (ARCOS, YERs, etc.) and state entities are accurate and submitted in a timely manner. Coordinate and file annual inventories. Monitor state licensing to ensure timely renewals and aid in the submissions of new state licensing as required.
</li><li>Support in the submission of DEA procurement Quotas, Supervise the import and export permits and declarations programs. Supervise the handling of Theft/Loss reports and file timely reports to DEA as needed.
</li><li>Supervise the employees conducting destruction of controlled substances waste materials as well as oversee and ensure proper documentation along with maintaining DEA compliant record keeping.
</li>Partner in conducting periodic, internal audits, file and maintain DEA record keeping. Serve as the Lead person Liason with Controlled Drug Substance Federal Regulatory Officials from the Long Island District Office of the Drug Enforcement Administration. 
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</li></ul> 
 
Additional Responsibilities:
<ul><li>Coordinates investigations of suspicious orders with Amneal&rsquo;s DEA compliance and supply chain to prevent diversion. Assume other duties as assigned.Complies with all company policies and standards. Supervise Compliance Auditors while conducting other Amneal site internal on-site inspection of NY, NJ and KY locations.</li></ul></div>
 <div>Education:
<ul><li>Bachelors Degree (BA/BS) With 4 Years of Experience - Required
</li><li>Master Degree (MS/MA) With 2 Years of Experience - Preferred
</li></ul>Experience:
<ul><li>4 years or more in BA/BS: Regulatory, Compliance, Law Enforcement, or Military equivalent.
</li><li>2 years or more in MA/MS: Regulatory, Compliance, Law Enforcement, or Military equivalent.
</li></ul>Specialized Knowledge:
<ul><li>Knowledge and experience with FDA and DEA regulations, particularly 21 CFR Part 1300 to end. MS Office; Knowledge and experience in the areas (min. 3) of ARCOS, NYSDOH, YERS, DEA documents to include registration applications, import/export permits and declarations and Quota request forms.
</li></ul>The base salary for this position ranges from $100,000 to $110,000 per year. Amneal ranges reflect the Company&rsquo;s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life&rsquo;s many other commitments and opportunities.</div>

Associate Manager, DEA Compliance

<div>
 
 Description
 
 
 
 
 JOB DESCRIPTION
 
 
 
 This role ensures GMP and GxP compliance in dispensing, manufacturing, and packaging. Responsibilities include machine and area clearance, product sampling, in-process checks, batch record reviews, and raw material verification. The position also involves approving packaging details, reviewing environmental and calibration records, managing change controls and deviations, and ensuring proper labelling and document archiving.
 
 
 
 Essential Functions
 
 
 
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 To perform Machine and area clearance during dispensing, manufacturing, and packaging operation.
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 To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in process samples and tmanage sampling aids.
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 To carry out in process checks, AQL and ANSI Sampling as per respective documents viz. protocol, BMR, BPR, SOPs and other GxP documents.
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 Review of Master BMR, SOPs, Batch Record Review and Batch Release, Shop floor management.
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 To ensure GMP practices at manufacturing shop floor.
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 To verify raw material dispensing activity.
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 To approve batch coding details during packaging operation.
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 Review of executed batch records and release for next processing stage.
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 Preparation and review of CPV data trend.
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 To perform impact assessment of breakdown memo.
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 To initiate change control, unplanned and planned deviation wherever required.
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 To review area, equipment, and cleaning log and tensure proper labelling.
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 To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records.
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 To perform calibration of IPQA instruments.
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 To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials.
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 To review and approve packaging artworks, proofs, and shade cards.
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 To archive executed documents like BMR, BPR, Hold time Protocol etc..
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 To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging.
 
 
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 </ul>
 
 Additional Responsibilities:
 
 
 
 <ul>
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 To monitor and record the environmental condition of label control room.
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 To prepare and revise functional SOPs, wherever required.
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 Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.
 
 
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 </ul>
 
 Skills
 
 
 
 <ul>
 <li>
 In-Process Checks &amp; Monitoring - Advanced
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 Batch Record Review - Advanced
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 Compliance and Regulatory Knowledge - Advanced
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 Internal Audits and Inspections - Advanced
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 Document and Record Review - Advanced
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 Line Clearance &amp; Batch Record Review - Advanced
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 Process Deviation Identification &amp; Handling - Advanced
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 Audit &amp; Regulatory Inspection Readiness (USFDA, EMA, MHRA, EUGMP,WHO) - Intermediate
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 Risk Assessment &amp; Change Control - Mastery
 
 
 </li>
 </ul>
 Monitors production processes in real-time to ensure compliance with specifications and GMP - Intermediate
 
 
 
 Qualifications
 
 
 
 Education: B. Pharm M.Sc / M.Pharm
 
 
 Experience: 7 years or more in 7- 9 years
 
 
 Expert in IPQA related all the key functions.
</div>

Assistant Manager / Deputy Manager - IPQA

Join Amneal Pharmaceuticals and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Amneal Pharmaceuticals

About Company

Associate Manager, DEA Compliance

Assistant Manager / Deputy Manager - IPQA