21 Aug
|
Important Company of the Sector
|
Chandigarh
21 Aug
Important Company of the Sector
Chandigarh
Key Responsibilities:
- Design and develop formulations for generic drug products (solid orals)
- Conduct pre -formulation and formulation studies, including excipient compatibility and stability testing.
- Experience in technology transfer
- Execute trial batches, scale -up, and exhibit batches as per QbD principles.
- Prepare and review Master Formula Records (MFR), Batch Manufacturing
- Records (BMR), and technology transfer documents.
- Coordinate with cross -functional teams (QA, QC, Regulatory, Production) during development and tech transfer.
- Participate in process validation and exhibit batch manufacturing.
- Handle troubleshooting during scale -up and validation at the plant level.
- Prepare product development reports and regulatory documentation as per MHRA/ICH/WHO guidelines.
- Ensure adherence to data integrity and GMP practices in all documentation and operations.
- Support regulatory filing documentation (e.g., CTD modules, product dossiers).