Senior Executive

Key Job Responsibilities

• Compliance & Quality Management:
• 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.