- To plan operational activities and ensure robust and trouble free transfer of manufacturing process technology for pharmaceutical Sterile dosage formulations (Pre-filled Syringes (PFS), Cartridge in Pen device, Vials, Ophthalmic etc) developed at the Drug Development Research Laboratory (DDRL) to the designated Receiving Unit (RU) inline with project time lines, all the while adhering to cGMP, GDP and other applicable norms and guidelines
Key Responsibility Areas:
A) Assessment Batches:
1. Calculate the batch size according to the feasibility of Receiving Unit (RU) equipment chain and the manufacturing process.
2. Ensure availability of Test license, cleaning method, SAP codes and vendor qualification for raw materials (RM), primary packing materials (PPM) required for the respective product.
3. Initiate and track procurement of raw materials (through SAP in case RU is USV site), primary packing materials, filter tubing, ensuring timely delivery to Receiving Unit (RU).
4. Ensure release of raw material, primary packing material in time for batches.
5. Provide necessary inputs to the Documentation team for preparation of assessment batch documents (BMR, Sampling Plan, Cleaning Plan etc.) and review the same.
6. File change controls for facilitation of assessment batch manufacturing, as applicable.
7. Execute the assessment batch/es by monitoring appropriately and providing technical inputs.
8. Compile analytical process data as per protocol and prepare an Assessment Batch Report and provide relevant recommendations for exhibit/submission batches.
9. After successful completion of assessment, provide inputs for creation of BOM in SAP for facilitation of material procurement of exhibit/ submission batches.
B) Exhibit/Submission Batches:
1. Participate in planning of exhibit/ submission batches.
2. Calculate the batch size according to regulatory requirements, equipment constraints and area feasibility.
3. Check availability and release of API, RM, PPM and product specific consumable material (filter, tubing etc.); if unavailable, initiate the procurement along with RD Sourcing.
4. Collaborate with RD formulation scientists to prepare process QRA for proposed batch sizes.
5. Review the batch documents required for exhibit/ submission batches.
6. Ensure exhibit/ submission batches are manufactured at RU under supervision, by providing guidance based on product knowledge and relevant technical inputs and troubleshooting, wherever necessary.
7. Ensure stability charging of submission batches on timely manner and update the same in tracker.
8. Provide support and contribute in investigations for any OOS observations during manufacturing/over stability period of exhibit/ submission batches.
9. Provide timely feedback and updates to Team Leader.
10. Review the process validation report, Hold time study report and provide relevant recommendations if any.
11. Calculate and propose the intended commercial batch size based on annual sales forecast received from Knowledge Cell/ Decision Support Group.
12. Provide necessary inputs to the RU team for preparation of intended/proposed commercial batch documents (BMR, PVP etc.) and review the same.
C) Commercial launch validation batches:
1. Review the proposed intended commercial batch size based on current annual sales forecast.
2. Review the site documents prepared for commercial validation against RA approval package and exhibit batch documentation for correctness of process parameters, i.e. Batch Manufacturing Record Process Performance Qualification Protocol.
3. Monitor and provide technical support during the first 3 commercial launch validation batches to minimize chances of failures.
4. Review the Process Performance Qualification Reports of the commercial launch validation batches vis--vis the executed batch records.
5. Track and review the analytical results from the commercial launch validation batches.
6. Preparation of Technology Transfer closing report after successful completion of commercial launch validation batches and respective PQR.
D) Documentation:
1. File a change control for new product introduction at RU, as applicable.
2. Provide necessary support for OOS/deviation investigations during exhibit/submission/commercial launch validation batches.
3. Prepare Addendum to QRA post exhibit/submission batches and 6 month stability report availability, before the commercial launch validation batches.
4. Keep an update of inventory for filter, tubing and other special aids required for sterile formulations at respective RU.
5. Review BMR of commercial batch (if required).
6. Maintain plant utilization for DDRL products.
7. Contribute to the development and revision of Standard Operating Procedures (SOPs) related to Formulation technology transfer, ensuring compliance with cGMP guidelines.
8. Provide the necessary inputs for the scope of work (SOW) document, especially regarding products for out bound transfers and new products to be transferred to Contract manufacturing organisation (CMO).
E) Self - development and learning:
1. Attend all mandatory trainings.
2. Take initiatives for self - development and update self on recent developments in own area of work.
