SOP Adherence & Training : Perform all activities in strict accordance with the current version of SOPs and ensure all tasks are executed as per established training curriculums. Schedule and conduct on-the-job training for new departmental employees as a trainer and training coordinator, ensuring practical technical staff training.Manufacturing Management : Oversee and manage daily manufacturing activities and manpower, ensuring consistent batch manufacturing to keep theoretical yields within established limits. Participate directly in batch activities, performing tasks according to Batch Manufacturing Record (BMR) instructions.Equipment & System Management : Lead and participate in equipment qualifications and Computer System Validation (CSV) activities. Coordinate with the Engineering Department for scheduled preventive maintenance and calibration.Material & Supply Chain : Responsible for the receipt, usage, and storage of packaging materials (PPM), raw materials (RM), and critical consumables via SAP. Coordinate with the Supply Chain Management (SCM) team to procure materials necessary for batch manufacturing.Quality & Compliance : Handle change controls, deviation management, Corrective and Preventive Actions (CAPA), qualifications, and validations in coordination with the Quality Assurance (QA) department. Ensure timely review of audit trails for respective equipment. Monitor cleaning and sanitization activities to maintain controlled environment conditions.Documentation & Audits : Prepare, review, and execute departmental SOPs, log books, and batch records. Responsible for the verification of online documentation and ensuring timely completion of training records.Validation & Projects : Actively participate in validation activities and assist with planning scheduled validation activities. Gain exposure to Greenfield projects and the handling of new equipment.Coordination & Planning : Coordinate with the Microbiology (MB) team to initiate gowning qualification and environmental monitoring (EM) activities as per schedule to avoid production delays. Coordinate with Quality Control (QC) and QA to initiate line clearance activities.Financial & Reporting : Prepare the yearly budget for production and Capital Expenditure (CAPEx).Skills Required
Sap, Validation, Sops, Manufacturing, Qualification, Capa