Senior Executive

4 weeks ago

Gangtok, India Alkem Laboratories Full time

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

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