Technology Transfer Specialist

3 weeks ago

Nashik, India USV PRIVATE LIMITED Full time
Role: Assistant Manager- Technology Transfer (Sterile)

Qualification : M. Pharm

Location : Govandi ( East ), Mumbai

Candidate Profile: Candidate must have the knowledge related to Pre-filled Syringes (PFS), Cartridges, Design history file (DHF) Pen Devices project

Job Responsibilities:

Pilot Lab

 Facilitate pilot BE batches at Govandi pilot lab (documentation, support in execution etc.)

 Monitor and ensure environmental control, area/ equipment/ qualification/ calibration as per pre-determined frequency

 Plan and execute scale-up/ optimization batches.

 Monitor and ensure availability of lab consumables, equipment AMCs etc. for smooth functioning of the lab.

 Support & participate in FAT and/or SAT for new equipment procured for pilot lab.

 Assessment Batches

 Calculate the batch size according to the feasibility of plant and process

 Initiate procurement and track receipt of raw materials at the plants.

 Ensure release of Raw Material in time for plant batches

 Prepare a process QRA for proposed batch size along with R&D formulation scientist.

 Provide inputs to the Documentation team member for preparation of assessment batch documents (BMR, Sampling Plan, Cleaning Plan etc.) and review the same.

 File change controls as applicable for conducting assessment batches.

 Execute the assessment batch/batches by monitoring appropriately and providing technical inputs

 Compile analytical & process data as per protocol and prepare Assessment Batch Report

 After successful completion of assessment, provide inputs for creation of BOM in SAP for facilitation of material procurement of exhibit/ submission batches.

Exhibit/ Submission Batches

 Participate in planning of exhibit/ submission batches

 Calculate the batch size according to regulatory requirements, equipment constraints and area feasibility

 Check availability and release of API, RM & documents at plants; if unavailable, initiate the procurement along with R&D Sourcing

 Review the documents required for exhibit/ submission batches

 Execute exhibit/ submission batches by providing relevant technical inputs and troubleshooting, wherever necessary

 Provide support and contribute in investigations for any OOS observations during manufacturing/ stability.

 Provide timely feedback and updates to Team Leader

 Review the process validation report and provide relevant recommendations if any.

 Calculate and propose the intended commercial batch size based on annual sales forecast received from Knowledge Cell/ Decision Support Group.

Commercial launch validation batches

 Review the calculations of intended commercial batch size based on current annual sales forecast.

 Review the site documents prepared for commercial validation against exhibit batch documentation for correctness of process parameters, i.e. Batch Manufacturing Record & Process Performance Qualification Protocol

 Monitor and provide technical support during the first 3 commercial launch validation batches to minimize chances of failures

 Review the Process Performance Qualification Reports of the commercial launch validation batches vis-à-vis the executed batch records.

 Review the results of the commercial batches Documentation

 Prepare technical documentation with respect to critical area/ equipment. E.g. pilot lab SOPs, Equipment qualification protocols etc.

 Provide necessary support for OOS/ deviation investigations during exhibit/ submission/ commercial launch validation batches

 Keep an update of inventory for filter and other aids required for sterile formulations

 Review BMR of commercial batch (if required)

 Maintain plant utilization for DDRL products

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