Job
Description
Role Overview: The Shift Chemist at Pharma Manufacturing department is responsible for achieving the desired production yield of pharmaceutical APIs by ensuring all production activities in the shift comply with cGMP, cGLP, EHS requirements, and specified operating procedures. You will be required to properly take over shift operations as per defined procedures. This includes following the Gowning Procedure before entering the pharma area, indenting raw materials from stores, updating balance in Material Reconciliation Record, collecting Intermediate material, ensuring availability of Utilities before charging the batch, verifying and charging raw material quantities, executing production process, recording process parameters progressively in Batch Manufacturing Sheet, participating in cleaning and process validation during batch startup process, and carrying out Filtration Activities. It is essential to adhere 100% to cGMP practices in line with 21 CFR, as well as EHS requirements applicable to the production shop floor. Maintaining Housekeeping and Hygiene in the shop floor area, ensuring Pest Control, dispensing required samples to QC, performing packing activity, and dispensing finished material to stores for dispatch are also key responsibilities. Timely reporting of abnormalities/deviations to the immediate supervisor/appropriate authority is crucial. You will be responsible for live recording of each activity in Batch Manufacturing Sheet and other records, as well as handover completed documents to Shift Incharge/ongoing documents to reliever. Additionally, providing support to plant maintenance staff for preventive maintenance schedules, coordinating with plant maintenance team to ensure temperature, pressure, and humidity, resolving breakdowns during the shift, and successfully completing assigned trainings are part of the role. Key Responsibilities: - Follow defined procedures for shift operations including Gowning Procedure, raw material indenting, Material Reconciliation Record update, Intermediate material collection, Utilities availability check, raw material verification and charging, production process execution, process parameter recording in Batch Manufacturing Sheet, cleaning and process validation, and Filtration Activities - Adhere strictly to cGMP practices, 21 CFR regulations, and EHS requirements - Maintain Housekeeping, Hygiene, Pest Control, dispense samples to QC, perform packing activity, and dispatch finished material to stores - Report abnormalities/deviations timely to the supervisor/appropriate authority - Record all activities in Batch Manufacturing Sheet and other documents, handover completed documents to Shift Incharge/ongoing documents to reliever - Provide support to plant maintenance staff, coordinate for preventive maintenance, ensure temperature, pressure, humidity, resolve breakdowns, and complete assigned trainings Qualifications Required: - B.Sc. in Chemistry (M.Sc. in Chemistry preferred) - Minimum 2 years of experience in production and quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies Additional Company Details: N/A,