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- Drive initiatives to enhance operational processes and equipment performance, aiming to achieve the highest standards of manufacturing excellence.
- Lead thorough investigations into non-conformance incidents, developing comprehensive reports on issues related to quality and Environment, Health, and Safety (EHS) observed during manufacturing or batch reviews.
- Proactively monitor existing processes and equipment to identify opportunities for improvement and implement effective solutions.
- Provide strategic input and recommendations on operational improvements that align with business targets and contribute to overall manufacturing success.
- Review and contribute to the development of batch-related recipes (such as those in POMS and DeltaV), manual operations procedures, and additional manufacturing documentation to ensure accuracy and efficiency.
- Offer expert input or review the design of batch and cleaning manufacturing recipes within the Distributed Control System (DCS).
- Lead and manage digitalization projects that align with and support the company's strategic business objectives, enhancing automation and efficiency.
- Conduct training sessions for operators on processes and procedures, ensuring compliance and proficiency in operational practices.
- Adheres to safe work environment in accordance with regulatory and global/local EHS policies.
- Leads/participates in safety risks assessments or participates in process hazard analysis as an operations representative (PHA).
- Actively resolve batch related document errors in a timely manner.
- Communicates all events/issues effectively with relevant stakeholders.
- Provide inputs for investigation - impact assessment and appropriate CAPA.
- Ensures overall plant upkeep during the shift and ensuring plant is always in audit ready mode.
- Oversees deliverables ahead, anticipates complexities and prevents potential delays.
- Ensures processes are running as per planned schedule with minimal delays. Highlights effectively to shift supervisor if delays are expected.
- Degree in Chemical Engineering/Chemistry or equivalent technical related diploma is required.
- At least 3 - 4 years of experience in working in a GMP manufacturing environment is preferred.
- Familiar with DeltaV and MES system.
- Yellow Belt certification would be preferred.