To provide support for execution and monitoring of trial, scale up, exhibit process qualification batches.
To prepare and review new product documents like material requirement sheet, master formula card, bill of material, master formula, risk assessment reports sampling protocol, reports, exhibit batch manufacturing record and exhibit protocols and reports etc.
To prepare and review new product documents like sampling protocol and trial batch reports investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
To Provide the regulatory response.
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.
To review and evaluate product history and process parameters for technical remediation and improvement of product robustness.
To prepare and submit the investigation reports for OOS, OOT and any failure for exhibit/validation/commercial batch manufacturing and during stability testing.
Track wise related activities Change control/CAPA/Planned deviations/Unplanned deviations related activities etc.
To prepare and review product containment approach and risk assessment for new product.
To prepare and review risk assessment report for elemental impurities/Nitrosamine impurities/residual solvent.
To 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 prepare and review standard operating procedures, training schedule, and conduct training
To participate in various regulatory audits to support the plant.
