Posted:-1 days ago|
Platform:
Work from Office
Full Time
1. Responsible to review technology transfer documents received from R&D
2. Responsible to ensure completion of new product introduction at site by effective gap assessment in coordination with cross functional departments.
3. Preparation of scale up batch BPCR, protocol, reports and monitoring of scale up batches and technical support during execution of scale up batches.
4. Handling of new product change controls and knowledge in QMS activities
5. Monitoring of exhibit batches and technical support during execution of exhibit batches.
6. Responsible to conduct new product technical meetings for product process validation activities with cross functional departments and R&D/External R&D as per requirement.
7. Responsible to provide support for regulatory department for product filing activities.
8. Responsible to provide technical support for preparation and review of batch records, protocols and reports .
9. Monitoring to ensure sampling activities as per protocol and stability charging of exhibit batches
10. Responsible for ensuring materials (API/RM/PM/Consumables) availability required for scale up and Exhibit batches.
11. Responsible for preparation and review of SOPs and other cGMP documents .
12. Responsible to follow Safety, Data Integrity policies and Code of ethics at the work.
3-6 yrs in MSAT(Injectables)
Qualification: B.Pharm/M.Pharm
Anthea Pharma
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