Amneal Pharmaceuticals

Senior Officer, Quality Control

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  10 days ago
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Job Description

The position is responsible for in-process and final product quality analyses and inspection in compliance with established specifications, standards, and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision using approved methods, calibrated instruments, and defined procedures. The role tests random samples of finished goods, audits and monitors manufacturing processes and outputs against internal and regulatory standards, and identifies ongoing quality issues to prevent potential production risks. The position supports accept/reject decisions, reports manufacturing process deviations and defects, maintains robust documentation, and contributes to continuous improvement in product quality and compliance.


Essential Functions:

  • Perform In-Process Testing (IPT) and Finished Product (FP) Testing as per approved specifications
  • Interpret and evaluate analytical results for accuracy, precision, and compliance
  • Execute Sampling and Testing Procedures for RM/PM (Raw Material / Packaging Material)
  • Review and approve Certificate of Analysis (COA) Documentation
  • Conduct Review of Analytical Data (RM/PM/FG/IP/IV) and ensure data integrity
  • Identify quality issues and support Change Control & Deviation Management
  • Review and investigate Out-of-Specification (OOS) and OOT (Out of Trend) results
  • Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)
  • Maintain Good Documentation Practices (GDP) and laboratory records
  • Support Internal and External Audits and regulatory inspections
  • Use analytical instruments and measuring devices for accept/reject decisions
  • Report manufacturing deviations, defects, and improvement recommendations



Additional Responsibilities:

  • To be responsible for Investigation related to LIR, deviations, OOS and OOT.
  • To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's.
  • To be responsible for Handling of Caliber e-LIMS
  • Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance.

Education:

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

Experience:

  • 3 years or more in 3 - 6 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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