Company: Hetero Pharma Ltd.
Post: Technology Transfer.
Experience: 4 to 7 Yrs
Designation: Executive / senior Executive
Location: Hyderabad
Job Description:
- To prepare standard operational procedure (SOP) and to ensure compliance of the same.
- To review the Technology Transfer Package documents.
- To prepare Master formula card and Master packaging card.
- To prepare technology transfer documents such as Technology transfer protocol, Technology transfer report and checklist.
- To prepare and review the batch calculations related to scale-up batch, exhibit batches and validation batches.
- To prepare scale-up batch manufacturing record (SBMR) and scale-up report.
- To prepare a sampling plan for scale-up batches.
- To prepare Material requisition notes for the dispensing of the scale-up batch materials and Placebo Batch Material.
- To review punch tool drawings.
- To ensure the availability of the equipment required for the execution of the scale-up batch, exhibit batches and validation batches.
- To execute and monitor the Scale-up batch, Exhibit batches and validation batches.
- To prepare and Monitor placebo batch.
- To review the batch manufacturing record, batch packaging record, process validation protocol and process validation report.
- To initiate and comply with Quality Management systems such as Change control, deviations, and incidents.
- To follow Good Documentation practices and to ensure compliance towards Data Integrity and current good manufacturing practices.
- To coordinate with Cross-functional departments for smooth transfer of technology transfer products.
- To involve in Troubleshooting of Commercial batches/ Validation batches.
- To address regulatory queries, if any.
- To prepare the Technical Inputs for finalized Batch sizes.
- To prepare & review the IOC related to ‘samples/Testing requirements request’ to send the samples.
- To initiate product code requests for new products.
Responsible to execute the additional functions as instructed by the superiors from time to time.
Please share the profile with edukondalu.m@heterodrugs.com
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