Job Description

The role involves ensuring robust Quality Management System (QMS) compliance and adherence to current Good Manufacturing Practices (cGMP) in the PDL department. The candidate will support and execute scale-up, pre-exhibit, exhibit, and validation batches for regulated and domestic markets. This includes hands-on involvement in technology transfer, documentation review, troubleshooting during batch execution, and collaboration with cross-functional teams. The incumbent will play a key role in launching new products, ensuring timely delivery, and managing technical documentation and systems.
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.