Ahmedabad, Gujarat, India · On-site
Description: Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing pro…
Skills: ANDA Submission, Post-approval Procedures, ICH Guidelines, USFDA Guidelines, Sterile Dosage Forms
Ahmedabad, Gujarat, India · On-site
Description: The role is responsible for end-to-end leadership, supervision, and control of injectable manufacturing operations while ensuring strict adherence to cGMP (current Good Manufacturing Practices). Essential Fu…
Skills: Aseptic Manufacturing, cGMP Compliance, Vial Line Operations, Isolator Technology, CRABS Technology
Piscataway, New Jersey, United States · On-site
$90k–$110k/yr
Description: The Project Engineer supports engineering projects related to sterile/aseptic manufacturing, including facility construction, utility upgrades, modifications, and new equipment installations. This role assis…
Skills: Project Management, cGMP Compliance, FDA Regulations, AutoCAD 2D/3D, P&ID Interpretation
Ahmedabad, Gujarat, India · On-site
Description: The role is responsible for delivering responsive, day-to-day IT technical support to employees across the organization, ensuring stable and secure operation of hardware and software systems. It focuses on d…
Skills: IT Technical Support, SAP Access Support, SOX Compliance, Incident Management, Troubleshooting
Brookhaven, New York, United States · On-site
$83k–$103k/yr
Description: The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written proce…
Skills: Chemical Analysis, IR Spectroscopy, UV-Vis Spectroscopy, Chromatographic Techniques, X-ray Diffraction
Brookhaven, New York, United States · On-site
$17/hr–$18/hr
Description: This role will be responsible for maintaining cleanliness and sanitation in our pharmaceutical manufacturing and office facilities. The Janitor will be responsible for ensuring a sterile environment in compl…
Skills: Sanitation, GMP Compliance, Waste Disposal, Chemical Handling, Facility Maintenance
Brookhaven, New York, United States · On-site
$85k–$100k/yr
Description: The Continuous Improvement Engineer is responsible for optimizing manufacturing processes, improving operational efficiency, reducing costs, and ensuring compliance with regulatory standards within pharmaceu…
Skills: Lean Manufacturing, Six Sigma, DMAIC, Value Stream Mapping, GMP
India · On-site
Required Experience of: Receipt, storage and dispensing of Raw Material & Packaging Materials as per their respective Sops. Online documentation for all transactions of materials and all activities which are to be done i…
Skills: Precision Weighing, Measuring, GMP Compliance, SOP Compliance, Documentation Accuracy
Ahmedabad, Gujarat, India · On-site
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 r…
Skills: cGMP Compliance, In-Process Quality Assurance, Documentation Review, Sampling, Area Clearance
India · On-site
To analyse In-Process, Finished Product, Stability, Process validation samples as per current STP/SOPs/ Specifications & Pharmacopoeias.To operate analytical instruments like Rheometer, Viscometer, UV-VIS, Dissolution, K…
Skills: Quality Control, Analytical Instrumentation, UPLC, HPLC, FTIR
India · On-site
Role Summary: The position is responsible for the preparation, review, maintenance, and lifecycle management of QC master data in Caliber LIMS, ensuring compliance with approved specifications, GMP requirements, data int…
Skills: Caliber LIMS, GMP, GLP, Data Integrity, ALCOA+
Glasgow, Kentucky, United States · On-site
The position of Warehouse Associate is responsible for all aspects of warehouse functions including the receiving, storing, handling, pick/pack operations, preparing and shipping of product for customer delivery, while m…
Skills: Packing, Order Fulfillment, Forklift Operation, Pallet Jack Operation, Loading and Unloading
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Responsible for managing ANDA submissions and post-approval procedures, including drafting annual reports and PAS filings. Coordinates with cross-functional teams to ensure timely regulatory submissions and maintains regulatory information according to USFDA and ICH guidelines.
Requires a B. Pharm degree (M. Pharm preferred) and 5 to 8 years of experience in regulatory affairs. Must have expertise in sterile/complex injectable dosage forms and proficiency in CTD module drafting.
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. 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 [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. 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 [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
