Amneal Pharmaceuticals

Executive, Quality Control

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  7 days ago
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Job Description

Responsible for overseeing and executing microbiology laboratory activities, including microbiological testing, water analysis, environmental monitoring, method validation, equipment qualification, and laboratory documentation. Ensure compliance with GMP, GLP, data integrity, pharmacopoeial, and regulatory requirements.

Essential Functions:

  • Perform microbiological testing of finished products, stability samples, water, and utilities.
  • Conduct environmental monitoring of laboratory and production areas.
  • Perform microbiological method validation/verification and equipment qualification.
  • Prepare and review SOPs, STPs, specifications, protocols, and laboratory records.
  • Ensure compliance with GMP, GLP, data integrity, and regulatory requirements.
  • Review analytical data, LIMS records, and audit trails for accuracy and compliance.
  • Support internal, customer, and regulatory audits, investigations, and CAPA.
  • Monitor laboratory resources, housekeeping, hygiene, safety, and consumables.
  • Train and assess microbiology personnel for competency.
  • Ensure laboratory operations remain audit-ready and support continuous improvement.

Education:

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

Experience:

  • 5 years or more in 5 - 8 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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