Senior Executive
- Sikkim
- Permanent
- Full-time
- Ensure strict adherence to QMS and cGMP guidelines within the PDL department.
- Batch Execution Support:
- Provide technical support in scale-up, pre-exhibit, exhibit, validation, and placebo batch execution.
- Troubleshoot issues during exhibit and commercial validation batches.
- Technology Transfer:
- Handle tech transfer of products from Alkem’s regulated sites (Baddi and Daman) to the Sikkim plant.
- Act as a liaison between R&D and the manufacturing site.
- Documentation & Review:
- Review BMRs, protocols, and reports of exhibit and validation batches.
- Monitor and document experimental batches accurately.
- Deviation & Change Control:
- Review deviations, incidents, and change controls, and support them with scientific rationales.
- Cross-Department Coordination:
- Interface with departments like QA, QC, Planning, Procurement, Production, and R&D for smooth product transfers.
- Facility & Resource Evaluation:
- Assess feasibility and capability of facility and systems for tech transfer and batch execution.
- New Product Launch:
- Monitor new product launch batches to ensure timely delivery to the market.
- Investigation Support:
- Execute investigation trial batches (e.g., OOS/OOT) along with QA, Production, and R&D teams.
- Data Management:
- Compile and manage data related to PDL batches.
- System Handling:
- Manage activities on e-DMS and e-TMS platforms.
- Function as the training coordinator for the PDL department.
- Additional Duties:
- Handle any other responsibilities assigned by the department head.