Amneal Pharmaceuticals is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our nearly 6,000 colleagues are working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry. Today’s healthcare environment requires a new approach and new ideas. While staying true to our reputation for quality, service and value, we are reinventing our processes, our playbook and our creative partnerships. We are focused on delivering outcomes that meet important medical needs, make quality medicines more accessible and more affordable, and provide solutions for tomorrow’s health challenges. Our leadership and global colleagues are deeply experienced and forward-thinking. We have the capabilities, scale and resources for growth and success. We are nimble and determined. We are Amneal and We make healthy possible.
We at Amneal Pharma looking for Regulatory Affairs professionals. Request to find below the required details:
- Experience: 08-13 Years
- Position: Assistant Manager
- Job Location: Ahmedabad
Note:
Person should have exposure of International Division – SIE (Strategic International Expansion) – Markets includes but not limited to – EU, Canada, China, AUS, ANZ, South Africa, Brazil, LATAM, MENA, CIS, SEA, Africa, Korea, Isreal etc.
Interested candidates may share their updated CV at kavitriy@amnealindia.com
Related Jobs: Amneal Pharma – Openings in Quality Control (OSD) | Apply Now
Amneal Pharma is looking for Process Development / Technology Transfer – Injectable professionals based at Ahmedabad. Please find the job specification below:
- Designation: Assistant Manager / Manager
- Experience: 9-13 Years
- Exposure Required: Injectable dosage form exposure is must
- Market Exposure Required: USA Market
- Job Location: Ahmedabad
Job Description:
- Leading a Technology Transfer Team (Under R&D vertical) at Palli location and Oncology location at Hyderabad.
- Responsible to select Equipment at Oncology Facility & Palli Facility.
- Responsible for Preparation of Master BMR, BPRs and document management.
- Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
- Responsible for reviewing GMP related documents.
- 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.
- Responsible for reviewing GMP related documents as applicable.
- Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
- To get actively involve in Scale-up and Exhibit batches.
Interested candidates may drop their updated CV at kavitriy@amnealindia.com, mentioning the subject line-“Application for Tech Transfer – Injectable”
