Technical / Functional :

• All activities related to production and monitoring the process as per SOP’s.
• Communicate day to day process deviations and breakdowns of the equipment to concerned persons.
• Check and implement the process for cleaning of equipment as per the schedules.
• Responsible for housekeeping and implementation of day to day cleaning of process area.
• Responsible to indent the materials from the warehouse for the batch and store the material in the production area.
• Preparation, review and approval of monthly Reports and BPR’s BCR’s, OOS, Deviation, investigations reports, validation protocols reports, validation reports.
• Responsible to handle production processes as per BPR and cleaning as per BCR.
• Receiving of new documents form QA, reviewing the completed BPR’s and handover to QA.
• Preparation of daily production planning and ensuring the same.
• Allocating equipment to maintenance department as per preventive maintenance schedule.
• Responsible to monitor all instruments such as temperature indicators, pressure gauges and their calibrations according to schedules.
• Responsible to co-ordinate with QC for in- process/ intermediate /finished product sample results.
• Conducting & participating the training programmes related to production operations, GMP and safety.
• Responsible to maintain production records such as BPR’s and BCR’s.
• Responsible to responsible for maintain the QMS in department.
• Responsible to raise the requisition for BPR’s/BCR’s/ Records/Formats from QA.
• Supervising shift activities as a shift in charge.
• Responsible to organize the manpower during shift as per safety norms.
• Follow-up safety systems in the plant.
• Responsible to adhere all safety practices such as using safety items as and when it is essential to handle for disposal of waste.
• Responsible to maintain Solvent Recovery Unit.

Technical / Functional :

• To plan and execute new products and provide necessary process engineering inputs for scaling up of lab process to pilot and plant scale with efficient collaboration between the cross functional departments.
• Participation in pilot plant operations and studies for scale-up at plant level, execution and monitoring of trial and validation batches in coordination with manufacturing team.
• Selecting the operating methods, facility requirements, equipment for effective scale-up and troubleshooting in process scale-up activities.
• Preparing the PFD, P&ID, Volume Calculations, Time Cycle, HAZOP, Pre-Validation &Validation Report.
• Reviewing data of powder safety test for Technology Transfer of Intermediate / API and review of TSU, RC, DSC data for evaluating the thermal hazards of process.
• Keeping track on availability of all raw materials required for trial, validation and Developmental batches
• Interacting with vendors for equipment with new technology evaluation and implementation in existing production facility to improve the product / plant systems.

Behavioral :

• Skilled in MS-Excel.
• Skilled in handling Cross functional team, for smooth execution of project.
• Willingness to travel frequently.
• Adopt technology, from lab batch observations to plant scale.

Disclaimer: