Officer - Production

Job Description

RESPONSIBILITIES Preparation and review of master batch records / batch manufacturing records, qualification documents (URS, DQ, IQ, OQ, PQ, volumetric calibration, surface area calculation etc.) & QMS documents. Preparation and review of standard operating procedure. Preparation and review of organogram, job responsibility, training needs & list of list. Preparation and review of training matrix & training plan. To ensure online documentation related to all CGMP activities including data integrity. Initiate, review & complete required change control, deviations, investigations & CAPA impact. Reviewing & maintaining all logbooks in the manufacturing area and plant. Operation of primary and secondary water treatment plant as per standard operating procedure and look after operations in solvent recovery plant. Responsible for performing validation & qualification activities in the plant (equipment qualification, process validation, cleaning validation). Responsible for the execution of validation & scale up batches for all the products to be manufactured. Proper utilization of available manpower (no contract people) & manufacturing facilities to enhance productivity. Ensuring timely manufacturing schedule as per production planning & maintaining quality & safety parameters. DESIRED SKILLS Must have experience in API production in reputed pharma organizations. Should have hands on experience of Manpower Handling Strong knowledge of operating DCS (Distributed Control System) One Should Manage Shift Planning Handling of Water System Operation Handling of Process Equipments like Reactor, Centrifuge, RCVD, RVPD, FBD, Bin Blender, Co-mill, etc Good Knowledge of preparing BMR and BPR. Should have sound knowledge of drafting and reviewing of SOP’s. Good Communication and problem solving skills. Should be assertive, proactive, and self-driven. Ability to work in dynamic environment.