Implement a comprehensive quality management system (QMS) that will ensure QA oversight of internal and external activities including current good manufacturing, clinical, laboratory, and distribution practices (i.e.,GXP)Ensure compliance with domestic and international current quality guidelines and GXP regulationsEnsure clinical and commercial drug products are manufactured, tested, released, and distributed in accordance with Origin’s established specifications, procedures, clinical requirements, and appropriate GXP standardsImplement a GXP vendor quality management program, including vendor audits and quality agreements

ValidationPlanning and execution of validation and qualification activityTo review the Validation Master PlanPrepare the Re-validation schedule and execute the activity as per scheduleTo update validation master planTo review the Media Fill Protocol and reportExecution for Process validationTo review Hold Time Study protocols and reportsHandling Cleaning ValidationPlanning and Execution for HVAC system with Third partyTo review the list of calibration and validation of all equipments / instrumentsTo review certificate receipt from third party validationTo review preliminary SOP of QA, Process/Cleaning validation protocols and report and get it finalize after approval of QA HeadTo review Quality Management DocumentTo review the documents as current SOP and regulatory requirements.

ValidationPlanning and execution of validation and qualification activityTo review the Validation Master PlanPrepare the Re-validation schedule and execute the activity as per scheduleTo update validation master planTo review the Media Fill Protocol and reportExecution for Process validationTo review Hold Time Study protocols and reportsHandling Cleaning ValidationPlanning and Execution for HVAC system with Third partyTo review the list of calibration and validation of all equipments / instrumentsTo review certificate receipt from third party validationTo review preliminary SOP of QA, Process/Cleaning validation protocols and report and get it finalize after approval of QA HeadTo review Quality Management DocumentTo review the documents as current SOP and regulatory requirements.

ValidationPlanning and execution of validation and qualification activityTo review the Validation Master PlanPrepare the Re-validation schedule and execute the activity as per scheduleTo update validation master planTo review the Media Fill Protocol and reportExecution for Process validationTo review Hold Time Study protocols and reportsHandling Cleaning ValidationPlanning and Execution for HVAC system with Third partyTo review the list of calibration and validation of all equipments / instrumentsTo review certificate receipt from third party validationTo review preliminary SOP of QA, Process/Cleaning validation protocols and report and get it finalize after approval of QA HeadTo review Quality Management DocumentTo review the documents as current SOP and regulatory requirements.

ValidationPlanning and execution of validation and qualification activityTo review the Validation Master PlanPrepare the Re-validation schedule and execute the activity as per scheduleTo update validation master planTo review the Media Fill Protocol and reportExecution for Process validationTo review Hold Time Study protocols and reportsHandling Cleaning ValidationPlanning and Execution for HVAC system with Third partyTo review the list of calibration and validation of all equipments / instrumentsTo review certificate receipt from third party validationTo review preliminary SOP of QA, Process/Cleaning validation protocols and report and get it finalize after approval of QA HeadTo review Quality Management DocumentTo review the documents as current SOP and regulatory requirements.

ValidationPlanning and execution of validation and qualification activityTo review the Validation Master PlanPrepare the Re-validation schedule and execute the activity as per scheduleTo update validation master planTo review the Media Fill Protocol and reportExecution for Process validationTo review Hold Time Study protocols and reportsHandling Cleaning ValidationPlanning and Execution for HVAC system with Third partyTo review the list of calibration and validation of all equipments / instrumentsTo review certificate receipt from third party validationTo review preliminary SOP of QA, Process/Cleaning validation protocols and report and get it finalize after approval of QA HeadTo review Quality Management DocumentTo review the documents as current SOP and regulatory requirements.

ValidationPlanning and execution of validation and qualification activityTo review the Validation Master PlanPrepare the Re-validation schedule and execute the activity as per scheduleTo update validation master planTo review the Media Fill Protocol and reportExecution for Process validationTo review Hold Time Study protocols and reportsHandling Cleaning ValidationPlanning and Execution for HVAC system with Third partyTo review the list of calibration and validation of all equipments / instrumentsTo review certificate receipt from third party validationTo review preliminary SOP of QA, Process/Cleaning validation protocols and report and get it finalize after approval of QA HeadTo review Quality Management DocumentTo review the documents as current SOP and regulatory requirements.

Preparation, review and issue of finished product specifications for new / repeat commercial ordersPreparation, review and issue of finished product certificate of analysis to logistics dept. for commercial ordersPreparation and review of reports for in- process quality checks (semi- finished and finished samples) and co- ordination with logistics dept./ Mfg. unit for compliance/ non- compliance of the productsChecking/ proof- reading of artworks for commercial orders received from DTP teamChecking/ proof- reading of pre- printing proof / packing material control samples / shade cards received from printers and co- ordination with logistics team for compliance/ non compliance of the artworks/ packing materials