Production Planning & Execution for Contract Manufacturing Sites / Loan License Sites.
Daily Production activity supervision and documentation.
Production Plan Distribution.
Identify & Develop New CMOs in accordance with business need.
Perform Preliminary assessment for the identified CMO in coordination with F&D & CQA Team.
Ensure Data/Information related to the new products under consideration is arranged from the identified CMO.
Manage Technology Transfer at New Site.
Cost Negotiation.
Material shortages & Indenting.
Tracking for Daily Production Activity & Dispatches of the FG from different sites.
Coordination with Purchase Team (RM/PM) for the material requirement & delivery at site.
PR / PO preparation for Raw Materials / Packing Materials.
Preparation of Service Purchase Orders for production sites.
Maintain cGMP at locations.
Capacity to handle 4 – 5 locations at a time.
Pack Stock Inspection.
Procurement of Change Parts for Contract Manufacturing Sites.
Review of Validation Data.
Market complaint investigation.
Site Selection Audits.
Quality Agreement Preparation.
Periodic Audits at site with respect to Quality & Inputs.
Good Hands on Local / Export Market Products.
Inventory Management at location.
To achieve the target outputs.
WIP Statement / Yield Statement Verification.
Trouble shooting at location.
Handling of SAP system.
To maintain record of change part.
To monitoring the batches at CMU with regular basis.
To coordinates in audits during qualification of new CMU's and periodical stock audits.
Familiar with equipments used in Production activity.
Individually handling lab scale equipment.
Well trained in Pilot scale up batches.
Monitor stabilities studies as per ICH guideline.
Assisting in preparation of technical documents like – Bill of material, Product development protocol, Trial Batch Record, Batch production and control record.
Evaluate experimental results and plan accordingly.
Responsible for carrying out scale up activity f newly developed products.
Troubleshooting of different products and in different areas.
Good hand on documentation part related with Audits
Good hand on document review related with production department.
Reformulation & process development of existing products.
Cost Cutting / Batch Size Improvement / Yield Improvement.

Assistant Manager - LLM ( Production Planning)