Process Optimization and execution for new products for submission Trial, Scale up & Exhibit batches
To provide support for execution and monitoring of trial, scale up and exhibit batches.
To review and prepare new product documents like material requirement sheet, master formula card, bill of material, risk assessment reports, scale up protocol, reports, exhibit batch manufacturing record and exhibit protocols and reports etc.
To review and prepare new product documents like investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
To provide the regulatory response.
To send samples of scale up/exhibit batches to FDD for analysis purpose.
Process validation batches execution - New product Launch
To review and prepare new launch documents i.e. product history, trial protocol and report, process qualification protocol and reports etc.
To plan and monitor the trial batch/characterization batch and process qualification batches.
To share process knowledge to cross functional departments through presentation for smooth technology transfer.
To prepare and review investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
Commercial troubleshooting and improvement of product robustness
To review and evaluate product history and process parameters for technical remediation and improvement of product robustness.
To prepare and review investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
To plan and monitor the trial batch/characterization batch and process qualification batches
Documentation
To prepare and submit the investigation reports for OOS, OOT and any failure for exhibit/validation/commercial batch manufacturing and during stability testing.
To review and prepare product containment approach and risk assessment for new product.
To review and prepare risk assessment report for elemental impurities, residual solvent and Nitrosamine.
To prepare and arrange placebo for quality control testing, change part development and to evaluate feasibility of product etc.
To prepare and review statistical evaluation for process evaluation.
To participate in various regulatory audits to support the plant.
