Amneal Pharmaceuticals

Officer, Quality Control

Amneal Pharmaceuticals  •  Visakhapatnam, IN (Onsite)  •  4 hours ago
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Job Description

  • Perform analysis of Raw Materials, In-Process Samples, Intermediates, Finished Products, and Stability Samples as per approved specifications and test methods.
  • Conduct wet chemical tests such as Assay, pH, Loss on Drying (LOD), Water Content, Residue on Ignition, and other pharmacopeial tests.
  • Prepare and standardize volumetric solutions, reagents, and buffer solutions.
  • Perform analysis of Raw Materials, Intermediates, Finished Products, and Stability Samples as per approved specifications and test methods.
  • Conduct wet laboratory tests including Assay, Related Substances, pH, Loss on Drying, Water Content, Residue on Ignition, and other pharmacopeial analyses.
  • Preparation and standardization of volumetric solutions, reagents, and buffers.

Preferred Candidate Profile

  • Experience in a regulated API manufacturing facility.
  • Exposure to regulatory inspections and audit compliance activities.
  • Ability to work in shifts and meet testing timelines.

Key Responsibilities

  • Perform analysis of Raw Materials, Intermediates, In-process Samples, Finished Products, and Stability Samples as per approved specifications and test methods.
  • Carry out wet chemical testing including Assay, pH, Loss on Drying (LOD), Water Content, Residue on Ignition, and other routine analyses.

Skills Required

  • Hands-on experience in Wet Laboratory testing within an API pharmaceutical environment.
  • Good knowledge of pharmacopeial requirements (USP, BP, EP, IP).
  • Understanding of cGMP, GLP, GDP, and Data Integrity (ALCOA+) principles.
  • Proficiency in preparation and standardization of volumetric solutions, reagents, and buffers.
  • Experience in handling laboratory instruments such as UV-Visible Spectrophotometer, pH Meter, Karl Fischer Titrator, Analytical Balance, and Potentiometric Titrator.

Educational Qualification

  • M.Sc. (Chemistry/Analytical Chemistry/Organic Chemistry) / B.Pharm / M.Pharm
  • Strong understanding of cGMP, GLP, GDP, and Data Integrity requirements.

Education:

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