Senior Officer, Manufacturing Process Operations

5 - 9 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As an API Production Operator, your role involves operating and monitoring equipment used in various stages of API production. You will be responsible for ensuring the cleanliness and readiness of equipment before batch charging, maintaining accurate records, and executing batch operations strictly as per SOPs and GMP guidelines. Your key responsibilities include: - Operating and monitoring equipment such as reactors, centrifuges, dryers, millers, and sifters. - Ensuring cleanliness and readiness of equipment before batch charging. - Maintaining accurate records including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), and Batch Packing Record (BPR). - Monitoring and recording process parameters in real-time to ensure adherence to specifications and quality. - Reporting and coordinating with Engineering for any equipment breakdowns. - Handling raw materials, intermediates, and APIs ensuring proper storage and documentation. - Following standard procedures for sampling and in-process testing of materials. - Monitoring utilities in the plant and reporting abnormalities. - Performing daily verification and calibration checks of weighing balances. - Participating in periodic equipment cleaning and preventive maintenance. - Identifying process deviations, malfunctions, or quality concerns and reporting them immediately. - Supporting continual improvement by suggesting ideas for optimization and waste reduction. - Adhering strictly to safety practices and participating in emergency response activities. In addition to the above responsibilities, you will also be involved in: - Supporting process improvement initiatives and lean manufacturing practices. - Assisting in the qualification and validation of equipment and processes. - Ensuring readiness of the area for audits and investigations. - Participating in cross-functional meetings and maintaining discipline and GMP compliance. - Training and mentoring junior staff/operators on standard procedures and safe working practices. - Supporting the preparation and review of SOPs related to manufacturing activities. - Participating in safety drills, risk assessments, and incident investigations. - Coordinating with stores for timely availability of materials and reporting daily production updates. Your skills in API Manufacturing Operations, Batch Documentation, GMP Compliance, Process Monitoring, SOP Adherence, Safety, Material Handling, Team Coordination, and Communication will be essential for this role. Your proficiency levels range from Basic to Advanced in these areas.,

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