Manufacturing Supervisor

Manufacturing Supervisor - Langhorne, PAResponsible for ensuring that all manufacturing machinery and equipment's is manned with properly trained personnel to ensure that the production schedule is executed. Ensure that the manufacturing batch records are filled out as per the appropriate Standard Operating Procedures (SOPs).Key Duties and ResponsibilitiesPreparation of Standard Operating Procedures, revision of SOP'sEnsuring the Batch records, Standard operating procedures and validation protocolsInitiation and Implementation of Change controlsComply with cleaning and sanitization of manufacturing area including equipment, walls, floors and ceilings per procedureEnsure the assembling or set-up of process equipment's or machinesPreparation of User Requirement Specifications for equipmentActively involved in Batch manufacturing and process validationsPreparation of Validation protocols for equipment and executing the protocolsReview of Executed documents, log books, Protocols and batch recordsConducting the training for batch records, standard operating procedures and validation protocolsInteracting with cross functional team personnel to attain the flow of activities with complianceInvolved in preparation, participation of aseptic process simulation (media fill) activities and media fill planner according to respective protocolInvolvement in planning of production activity based upon API, packing and raw material availability, personnel availability and customer requirementsInvolvement in performance verification of major processing equipmentReport accidents, unsafe conditions or unusual circumstances to supervisorComply with FDA guidelines/Company Policies of Data IntegrityUnderstand and adhere to all cGMP and FDA regulationsExecution/ coordination of validation protocol testingOther duties as required or delegatedSupervisory **Supervise the daily actives and tasks to be performed to support the batch productionBecome the SME for the manufacturing process and equipmentWrite and modify SOPs for the manufacturing processTrain operatorsWork with scheduling and warehouse to assure we setup for production scheduleAssist with the writing of deviations/investigations and change controlsEducation and **Bachelor's degree in chemistry or scientific discipline preferredPrevious sterile aseptic experience is required3 years of previous pharmaceutical experience and at least 1 year of technical writing experienceContinuous working knowledge of applicable FDA/ICH/DEA regulations, and cGMP guidelines

Created: 2024-11-01