Production Operator – Formulations | Cipla | Pune

Role & Responsibilities:

• Strict adherence to safety, health, and environment.
• Carry out Manufacturing activities by following and monitoring standard operating procedure (SOP) and current Good Manufacturing Practices (cGMP).
• To ensure effective implementation of RFT and Data integrity policy.
• Maintenance, and upkeep of the department, premises, and equipment.
• To maintain discipline in the section
• To protect products and materials against spillage and deterioration
• Monitoring and Safely operating the machine as per SOP, with minimum rejection & maximum output.
• Improvement, continuous review and up gradation of existing SOPs & work systems and to ensure their strict implementation.
• To track the execution of cleaning activity of non-product contact/indirect product contact surfaces
• Discussion of the day-to-day work with the Section Head.
• To Coordination with other sections and departments.
• Check and Monitor for cleanliness and environmental conditions of area w.r.t. temperature, relative humidity, differential pressure, microbial control, fly control and AHU handling (SCADA).
• Ensure that all materials and finished products are stored under the appropriate conditions as per specification and along with batch segregation and stock rotation.
• To perform the study as per various Study protocols in areas.
• To perform activities such as Cleaning, Line Clearance, Operation, PPM and Calibration of equipment and area as per roles and responsibilities.
• To cooperate for investigation of deviations, OOS, OOT, and complaints observed as per Standard Procedure.
• To perform timely entries of data and completeness of Batch Manufacturing Records, Checklists, Logs, and Protocols on Issued Documents.
• To perform activities such as Calibration, Sanitization, Maintenance of DM Store, Inprocess store, and Clean Equipment Area.
• Maintain and monitor inventory required in the Department and Scrap the damaged inventory.
• To transfer In-process and Finished goods to the Inprocess store
• Checking raw material is dispensed for manufacturing of batches and Issuance of batches for processing of next stage and also ensure Preparatory set up work prior to the start of manufacturing activity.
• To monitor and maintain correct Status labeling of containers, equipment, area, and materials.
• Identification, classification, finding, quarantine, and destruction of rejects generated during the manufacturing process.
• Calibration of equipment, instruments weighing balances, and PPM as per schedule and maintaining records of the same.
• To Operate the SAP system, PRAMAAN (E-Log), LMS, and Cipdox system based on roles and rights Provided in the application.
• To be involved in the training conducted in the section (Scheduled training, Training on changes, Miscellaneous) and also as per the nominations given by the Section Head/ Department Head.
• Participating in Process Validation and Cleaning Validation in coordination with Quality Assurance.
• To prepare qualification & requalification of machine/equipment/area and to perform FMECA of machines in the manufacturing department.