Description:The Group Leader is responsible for operation of the Mixing and Granulation equipment in accordance with Company Standard Operating Procedures and maintaining 100% cGMP & compliance to ensure the production of quality products.Essential Functions:Working on the floor, assigning work to Level-I, II and III operators of daily production activities of scheduled batches and observing operators working inside the rooms.Possess excellent knowledge of all Mixing and Granulation equipment for Operation, Cleaning and Trouble shooting, Training and Coaching Level-I, II and III Operators.Review batch records for correctness after Mixing and Granulation activities are complete, sign/date and hand over to Supervisor.Train operators to run complex equipment and always keep back up operators for each equipment.
Provide on job training to operators periodically and submit training records.Monitor ability and skill of Mixing & Granulation Operator Level –I, II and III and submit recommendations to Supervisor.All instruments used in Mixing & Granulation Department are within calibration, preventive maintenance (PM) period, calibration sticker and PM sticker displayed.
Should be able to calibrate Moisture Analyzer as per Master Calibration Schedule.Additional Responsibilities:Other duties as assigned.Qualifications ExternalEducation:High School or GED RequiredExperience:5 years or more in Pharmaceutical, ManufacturingSkills:Planning, Scheduling and Time Management Experience AdvancedComputer proficient with good knowledge of JDE/MRP AdvancedAbility to Supervise/Manage, train and coach staff IntermediateFlexible to work extended hours when required IntermediateAbility to revise and write Safety Operating Procedure (SOP) IntermediateAbility to work as part of a team with understanding of monthly goals IntermediateAttention to detail and accuracy IntermediateSpecialized Knowledge:Knowledge of High Shear Mixer, Fluid Bed Processor, Fluid Red Drier, Delta Vita Micronizer, GPCG-60 and 120, Hot Melt Extrusion, Hobart Mixer, Gral-600