Amneal Pharmaceuticals

Senior Executive, QC Investigations

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  6 hours ago
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Job Description

The position is responsible for in-process and final product quality analyses and inspection in compliance with approved standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against established specifications. The role uses measuring devices, testing equipment, predefined methods, operations, and setups to support acceptance or rejection decisions. The position identifies ongoing quality issues, prevents potential production risks, and recommends improvements. The role audits, monitors, and determines the quality of manufacturing processes and outputs, tests random samples of finished goods, and reports manufacturing process deviations and product defects through structured investigations, ensuring robust GMP documentation, CAPA closure, and regulatory compliance.


Essential Functions:

  • Perform Investigation Analysis for OOS, OOT, deviations, and non-conformances
  • Review Review of Analytical Data (RM/PM/FG/IP/IV) and instrument audit trails
  • Conduct Laboratory Investigation & Change Control with root cause analysis
  • Execute CAPA Management & Documentation and effectiveness verification
  • Support accept or reject decisions based on investigation outcomes
  • Identify recurring trends and prevent potential production issues
  • Perform audit, monitoring, and determination of manufacturing process quality
  • Ensure compliance with 21 CFR Part 210 & 211 and GMP requirements
  • Review and approve Certificate of Analysis (COA) Documentation
  • Participate in Internal and External Audits and regulatory inspections
  • Maintain Good Documentation Practices (GDP) across investigation records



Additional Responsibilities: Education:

  • Bachelors Degree (BA/BS) B. Sc. - Required
  • Master Degree (MS/MA) M. Sc. - Preferred

Experience:

  • 8 years or more in 8 - 10 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 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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