Amneal Pharmaceuticals

Associate, IPQA

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  18 days ago
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Job Description

The role is responsible for ensuring continuous compliance with global GMP (Good Manufacturing Practices) requirements during manufacturing, packing, and dispensing operations. The role focuses on real-time quality oversight, line clearance, and in-process checks to ensure products are manufactured in accordance with approved procedures and regulatory standards. The role performs routine shopfloor monitoring, verifies cleaning, sterilization, and aseptic activities, and ensures accurate documentation and data integrity. The role supports process validation, cleaning validation, and aseptic process simulations, and contributes to risk mitigation, deviation management, and audit readiness, ensuring consistent delivery of safe, high-quality pharmaceutical products.


Essential Functions:

  • Perform IPQA (In-Process Quality Assurance) checks during manufacturing and packing operations
  • Execute and document Line Clearance and Readiness for manufacturing, packing, and dispensing
  • Conduct In-Process Checks & Sampling (In-process, Stability & ANSI)
  • Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)
  • Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and completeness
  • Ensure Good Documentation Practices (GDP – Good Documentation Practices) compliance.

Education:

  • B. Sc- Required
  • B. Pharm - Preferred

Experience:

  • 1 year or more in 1 - 4 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.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

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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