Executive, R&D Injectable Technology Transfer (R&D MSTG)

Amneal Pharmaceuticals -
Ahmedabad, Gujarat

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Job details

Full-time
7 days ago

Qualifications

Quality assurance
Bachelor's degree
Document management

Full job description

Part of Technology Transfer Team (Under R&D vertical ) at Pipan location
- 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.
    - Responsible 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.
    - Responsible for reviewing GMP related documents as applicable.
    - To get actively involve in Scale-up and Exhibit batches.
    - 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.

It will be advantage if candidate is having exposure to Infusion Bag Formulation / Terminally Sterilized products.

Education:

B. Pharm B. Pharm - Required

M. Pharm M. Pharm - Preferred

Experience:

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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