Amneal Pharmaceuticals

Assistant, Coating

Amneal Pharmaceuticals  •  Ahmedabad, IN (Onsite)  •  6 days ago
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Job Description

The role is responsible for executing coating operations under cGMP (current Good Manufacturing Practices) conditions within the pharmaceutical manufacturing environment. The role supports safe, compliant, and efficient processing of oral solid dosage (OSD) products, ensuring adherence to approved Batch Manufacturing Records (BMR – Batch Manufacturing Record) and Standard Operating Procedures (SOPs – Standard Operating Procedures). The role operates coating equipment, performs in-process checks, maintains accurate documentation, and ensures environmental, safety, and quality compliance during batch execution. The role contributes to product quality, yield optimization, contamination prevention, and regulatory compliance, while supporting continuous improvement initiatives and maintaining online documentation systems as required by regulatory standards.


Essential Functions:

  • Operate coating equipment in accordance with approved BMR (Batch Manufacturing Record) and SOPs (Standard Operating Procedures)
  • Perform in-process checks (IPC – In-Process Control) during coating operations & maintain E-logbook to ensure batch compliance
  • Monitor coating parameters such as spray rate, inlet air temperature, atomization, and pan speed
  • Maintain cGMP (current Good Manufacturing Practices) compliance during manufacturing operations
  • Record batch data accurately in BMR & BPR (Batch Production Record) and online systems
  • Ensure cross-contamination prevention through proper line clearance and cleaning practices
  • Follow change room gowning techniques and cleanroom behavioral practices
  • Support equipment cleaning & maintenance as per approved procedures
  • Identify and report deviations, abnormalities, or equipment issues promptly
  • Adhere to Environmental, Health & Safety (EHS – Environmental, Health & Safety) guidelines
  • Participate in training programs and continuous improvement initiatives
  • Support audit readiness by maintaining documentation integrity and traceability



Additional Responsibilities:

  • The role involves ensuring CGMP compliance and operation activity in manufacturing.
  • Responsibilities for Operating coating equipment and performing in-process checks during batch execution.
  • The position requires maintaining online documents.
  • IPQA instruments (e.g. Balance, DT machine, Moisture analyser etc) calibration.

Education:

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