Amneal Pharmaceuticals
Regulatory Submissions & Documentation. Prepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for…
This role is responsible for overseeing in-process and final product quality analyses and inspections within the quality control laboratory in compliance with…
Monitor and ensure adherence to enterprise data management procedures and standards. Enter / update master and reference data for assigned data domains (Products…
This role is responsible for defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials…
The role is responsible for planning, designing, executing, and maintaining civil and structural infrastructure across pharmaceutical facilities. The role ensures…
Cordinate and lead for all existing and future Industry 4.0 Use cases under implementation or planned in future as per guidance from Head, Digitalisation and…
We are looking for Upstream & Downstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Details of the Job…
Ensure compliance with the Gujarat Prohibition Act, 1949, and applicable excise regulations concerning industrial alcohol and regulated substances. Manage statutory…
This role is responsible for managing and overseeing injectable manufacturing operations within a regulated pharmaceutical manufacturing environment, ensuring the…
Responsible for managing, reviewing, maintaining, and controlling engineering documentation related to facilities, utilities, equipment, HVAC, and engineering…
This role is responsible for defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials…
This role is responsible for managing and driving operational excellence initiatives within a regulated pharmaceutical manufacturing environment, ensuring that…
Preferred Qualification: M. Pharm. Preferred Experience: 8-12 yrs (for AM/DM level). Preparation, scientific review, coordination & finalization of ANDA/NDA CMC…
To Support commercial troubleshooting/remediation/Market complaints for injectable manufacturing sites at Level 2. To support for timely investigation/execution and…
The role is responsible for overseeing day-to-day technical support operations for employees across hardware and software systems. The role focuses on ensuring…
Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form/Liquid…
Assist Regional Compliance Lead in drafting / amending policies and procedures for the India Operations based on the changes in the regulatory environment…
The role is responsible for leading and managing mechanical engineering activities supporting pharmaceutical manufacturing operations. The role ensures design…
The role is responsible for obtaining goods, raw materials, utilities, and services required across pharmaceutical business processes. The role leads product and…
Assist in the design and implementation of instrumentation and control systems for industrial processes. Prepare and review P&IDs, instrument lists, loop diagrams…
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