Amneal Pharmaceuticals

Assistant Manager, QC Investigation

Amneal Pharmaceuticals  •  Republic of India (Onsite)  •  3 hours ago
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Job Description


The Digital Audit Trail Reviewer is responsible for reviewing audit trails and electronic records generated from QC laboratory computerized systems to ensure data integrity, compliance with cGMP and regulatory requirements, and timely investigation of audit trail events. The role supports OOS/OOT investigations, root cause analysis, CAPA implementation, and regulatory inspection readiness.

  • Review audit trail records of QC computerized systems (e.g., Empower, LIMS, HPLC, GC, UV, Dissolution, Malvern, etc.) to verify compliance with Data Integrity requirements.
  • Identify, assess, and document audit trail events, ensuring that all activities are attributable, legitimate, and performed in accordance with approved SOPs and cGMP requirements.
  • Investigate any discrepancies or unusual audit trail events, determine the root cause, prepare investigation reports, and ensure timely closure of observations.
  • Maintain complete and accurate documentation of audit trail reviews in compliance with ALCOA+ principles and 21 CFR Part 11.

Education:

  • B. Pharm - Required
  • M. Pharm - Preferred

Experience:

  • 10 years or more in 10 - 13 Years

Specialized Knowledge: Licenses:

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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