Amneal Pharmaceuticals

Officer, IPQA

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  8 days ago
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Job Description

To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitoring, documentation review, sampling, and area/machine clearances, thereby supporting the production of high-quality injectable pharmaceutical products


Essential Functions:

  • To ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
  • To supervision of dispensing activity of manufacturing shop floor and packing areas.
  • To Issuance of Bottle label, Ouster and Medication guide for commercial batch.
  • Rsponsible for providing machine and area clearance.
  • To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol.
  • Online Documents and records review like equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
  • Calibration of IPQA instruments.



Additional Responsibilities:

  • Real-time Monitoring and Compliance Reporting.
  • Participation in Investigations.
  • Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.
  • Maintain IPQA-related documents and records in a state of audit readiness.
  • To have good written and verbal communication skills in English language.

Education:

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

Experience:

  • 2 - 4 Years
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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