Arthur Eke Email & Phone Number

Perform processing steps / Manufacturing activities, monitoring process against the batch record.Document / Record cGMP data and information for processing steps / equipment activities following standard operating procedure (Key documentation includes batch records and equipment logbooks.Completes / Review validation protocols, Deviation reports, change controls in accordance with cGMP.Perform the weighing, dispensing of raw materials for buffer and Media.Perform the preparation of small and large volume of media and buffer solutions, filtration and transfer of products.Operate bench top equipment including PH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.Dispensing, labeling, transfer/staging of raw materials and parts.Assembly/disassembly, cleaning and sterilization of components, parts and equipment.Maintaining equipment, area and cleaning logbooks.Cleaning sanitizing production rooms and equipment.Stocking production and cleaning supplies.May author/review/improve SOP’s, batch records, protocols, and technical reports.Actively participate in training activities, managing their individual training plan.

Execute and properly document cGMP logbook on cleaning activities.Perform general cleanroom housekeeping, including equipment cleaning, trash disposal and reports and complete GMP facility inspections as required.Receiving and Checking in materials of production, Spraying and collating materials to SOP and Batch record detailsWeigh/dispense Chemical formulation Mix for basic sanitation cleaning like Vesphene, Sporklenz and Bleach solutions mix for use.Bowie disk test setup for production.Autoclave dryingSupport QA during audits and regulatory inspections.Setting and changing vial washer machine cup combinations to reflect different batch as stipulated in batch release per LOT.Comply with cGMP regulations; adhere to company policies and SOP as it relates to batch Record directions.Assist in competency assessments and Training.Follow all written procedures according to GMP standards.Perform water sampling

Execute and properly document cGMP Bio manufacturing activities.Perform and monitor critical processes, execute routine validation protocols, work orders.Perform general cleanroom housekeeping, including equipment cleaning, trash disposal and reports and complete GMP facility inspections as required.Receiving and Checking in materials of production, Spraying and collating materials to SOP and Batch record detailsWeigh/dispense Chemical formulation Mix for basic sanitation cleaning like Vesphene, Sporklenz and Bleach solutions mix for use.Washing Vials of various sizes depending on batch release.Loading from Vial washer to oven racks for sterilizationPrepare fill lines according to batch record.Filling Vials and Syringes with medicines/products for batch release.Perform checks by monitoring the vials in accumulator isolator turn table.Realign vials on the isolator table in proper sequence to reduce line stopper jams.Bowie disk test setup for production.Perform Autoclave activities such as drying, Leak test and Warm up Tests.Preparing batches as designated in batch records like fill lines, Tubing etc.Defining various bubble points of materialsSupport QA during audits and regulatory inspections.Setting and changing vial washer machine cup combinations to reflect different batch as stipulated in batch release per LOT.Perform aseptic operations in sterile core in accordance with current industry, client and company.Comply with cGMP regulations; adhere to company policies and SOP as it relates to batch Record directions.

Support daily management of department duties.Allocating labor on associates.Attending sync briefings to understudy information required in the process.Provide wide range of administrative and logical support in basic business operational functions.Coaching associates with defective errors impacting to quality regarding business.Making boards and holding daily stand up briefs dissemination valid information to associates as it regards business.Receem associates for trainings and awards for quality and improvements.Mediate between associates and management in information and concern information.Monitor associated quality for changes to balance business and appraisals.Data management scheduling, calendar management and coordinating vendor relation.

Execute and properly document cGMP logbook on cleaning activities.Maintain inventory of consumables in cleanrooms.Receiving and Checking in materials of production, Spraying and collating materials to SOP and Batch record detailsClean filling and Manufacturing areas with GMP guidelines.Follow all written procedures according to GMP standards.Support QA during audits and regulatory inspections.Setting and changing vial washer machine cup combinations to reflect different batch as stipulated in batch release per LOT.Comply with cGMP regulations; adhere to company policies and SOP as it relates to batch Record directions.

Execute and properly document cGMP logbook on cleaning activities.Perform water sampling and EM sampling where required.Receiving and Checking in materials of production, Spraying and collating materials to SOP and Batch record detailsWeigh/dispense Chemical formulation Mix for basic sanitation cleaning like Vesphene, Sporklenz and Bleach solutions mix for use.Bowie disk test setup for production.Autoclave dryingReport to production supervisor on outcomes of responsibilities according to Batch records.Setting and changing vial washer machine cup combinations to reflect different batch as stipulated in batch release per LOT.Comply with cGMP regulations; adhere to company policies and SOP as it relates to batch Record directions.