Senior Executive

8 hours ago


Halol Gujarat, India Sun Pharmaceutical Industries Full time

Internal Job Posting Position Manager-II Department MSTG Grade G11 Job Location Dadra Experience Below 10 years 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



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