Summary: Operates anyone of the following technologies: dispensing, granulation, roller compaction, compression, encapsulation, coating & printing machines. Assure product complies with its specifications, cGMP's and SOP's to guarantee on time, high quality product at a low cost. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Responsibilities: 1. Operates, monitors, and feeds any of the following equipment to manufacture pharmaceutical solid dosage product following product specifications, cGMP and SOPs: Dispensing, Granulator (wet and dry granulations), Tableting, Film Coater, Encapsulation, and Printing machines. 2. Assures that all manufacturing documentation related to operation, cleaning are completed as required by manufacturing instructions. 3. Receives all ingredients (active and inactive) for dispensing to be used in the formulation of a drug product following established procedures assuring production materials availability 4. Cleans and sanitizes rooms (manufacturing room and wash room), dust collectors, storage containers (bins or vessels), and process equipment according to standard operating procedures. 5. Conducts swab samples for equipment cleaning verification and document all cleanings on the chronological record/cleaning register. 6. Operates forklift for materials and equipment movement. Knowledge/Skills/Education: · Bachelor Degree with no experience or High School Diploma with one (1) year of experience in one (1) of the following manufacturing technology areas: dispensing, granulation, roller compaction, compression, coating, encapsulating & printing machines. · Excellent Mathematical Skills · Knowledge in computers and/or Electronic Batch Record · Driver’s License Physical Demands and Skills: · Heavy work (25-60 pounds) that requires eye-hand coordination and moving about capacity. · Requires movements of objects such as lifting, carrying; pushing and pulling. It Involves body movements such as handling and, fingering. · Visual discrimination for near and depth perception. Mental Components: · Capacity to awareness, catalogue, detect, evaluate, inspect, observe and organize. · Notify immediate supervisor of any inconsistencies or violations to Company operation procedures and policies Working Conditions: · Work is performed in building’s interior. · Exposed to temperature changes, noise, odors, and atmospheric conditions. · Use personal protection Equipment such as uniform, vinyl wear, gloves, safety shoes, disposable wear, apron and safety glasses. Hazards: · Exposed to moving mechanical parts · Exposed to high potent ingredients · Exposed caustic chemicals Machinery, Equipment, Tools, Materials: Machines: Fluid Bed Dryer, High Shear Mixer, Roller Compactor, Blenders, Bin Stations Vima valves, Milling Equipment, Sieving Equipment, Tablet Presses, Coating Machines, Encapsulator Machines, Printing Machines, Inspections Machines Cleaning Machines (Bin Washers) Equipment · Finger lift · Pallets Jack · Isolators Tools · electric tools · measurement instruments (multi testers, recorders, analytical scales, compu-trac etc.) Materials: · cleaning materials Special Requirements: Forklift license. Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.
