Amneal Pharmaceuticals Hiring for R&D Technology Transfer, Global Regulatory Labeling

Amneal is a global essential medicines company powered by a robust U.S. generics business. Amneal is a growing branded business with deepening portfolios in institutional injectables, biosimilars and select international markets including India.

HIRING for R&D - Technology Transfer (MS&T) Injectable ; Global Regulatory Labeling

R&D - Technology Transfer (Injectable)
Posts : Officer / Senior Officer / Executive / Sr. Executive
Location : Ahmadabad (Palli / Sachana Plant)
Qualification : Graduate / Postgraduate
Experience : 02 - 07 Years
Required skills : • Responsible for Preparation of Master BMR, BPRs and document management.
• Responsible for coordination with various departments like RA. Manufacturing, Warehouse, QA. QC, Engineering for execution of Scale-up and Exhibit batches.
• Responsible for reviewing GMP related documents to select Equipment at Facility.
• To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes.
• To study critical parameters during scale up batches to optimize the CPPs and CQAs.
• To provide the input related to batch size, process feasibility & process parameters to formulation scientist as per requirement.
• To monitor and ensure readiness for execution of scale-up / feasibility batches, Exhibit batches with respect to RM. PM & Miscellaneous items. To get actively involve in Scale-up and Exhibit batches.
• It will be an advantage if candidate has Infusion Bag (TS & Aseptic) manufacturing exposure.

Global Regulatory Labelling
Posts : Assistant Manager,/ Deputy Manager
Location : Ahmadabad
Qualification : Graduate / Postgraduate
Experience : 07 - 12 Years
Required skills : • Compilation and/or initial review of labeling documents for OSD & Injectable for original ANDA and Additional strength submission.
• Co-ordinate with CFT for involvement and understanding of priorities and filing timelines.
• Follow-up with respective department to get documents in timely manner and to ensure that all labeling modules are available for submission on time.
• Initial review of all deficiency & query responses related to US Labeling for both OSD and Injectable.
• To ensure that all labeling modules are available for CR, IR and DRL submission on time. Co¬ordination with cross-functional teams as needed to collect required documents for deficiency responses.
• To achieve 100% launch readiness for all new products, with zero labeling issues. To ensure most recent and updated labeling has been issued Ok-To-Print. To ensure all printed labeling will be available for launch and on time. To ensure Drug listing of First Launch products after approval.
• Assist in review of all RLD updates of OSD & Injectable. To ensure that all labeling modules are available of RLD update for submission within time. To co-ordinate with supervisor for involvement and understanding of priorities.