Main purpose of the job

To ensure that operations conducted are performed in accordance with the requirements of Eisai Corporate Standards, Eisai Quality System, GMP and GDP Guidelines, and Industry Standards.

Duties are performed to ensure:

• A safe working environment is maintained for self and other Eisai employees, ensuring all near-miss incidents and accidents are reported in accordance with procedures.
• The quality of products manufactured and released is assured through adherence to all procedures.
• Opportunities to improve operations and reduce costs are identified and progressed through the continuous improvement and demand innovation initiatives.
• Eisai’s philosophy of hhc is at the forefront of daily activities.
• All stakeholder and customer expectations are understood and met through communication.
• Performance is in line with personal and Eisai objectives with demonstrated behaviors and competencies.

Main Duties / Responsibilities

• To set up production equipment to ensure correct functionality and calibration compliance.
• Operation of high-speed packaging line to maintain product quality and standards by carrying out effective controls and testing procedures.
• Responsible for completion of batch documentation, SAP process order confirmation, and other SAP transactions required for the production activity.
• Responsible for minimizing downtime to maximize productivity by managing priorities and having effective handovers and accurate line setups.
• Participate in the installation, qualification, and validation of new packaging equipment and tooling.
• Support Engineering and Contractor activities.
• Responsible for the effective training of others in systems/procedures/skills/techniques.
• Responsible for compliance to health and safety procedures in areas of responsibility. Actively promote safety awareness and improvements.
• Carry out in-process tests, yield calculations, product sampling, and inspection to ensure all production meets predefined quality attributes.
• Dismantle, clean, and reassemble equipment, ensuring it is well maintained.
• Write, review, and update packaging documentation, including Standard Operating Procedures.
• Participate in quality investigations and initiate deviations. Complete investigations and complete CAPAs on Trackwise.
• Responsible for compliance to Good Manufacturing Practices in areas of responsibility.
• Recording appropriate metrics to monitor adherence to production schedules, equipment utilization, right-first-time batch records, and adherence to SOP and training schedules.
• Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.
• Participates in internal, customer, and regulatory audits.
• Liaise with all other departments within EML to ensure business requirements are being met.
• Conduct Product Review of completed Batch Records and Checking of prepared Batch Records.
• Liaise with production planning to develop and maintain production schedules.
• Assist Packaging Technicians in packaging machine routine maintenance.
• Carry out Production Facility Cleaning and Sink and Drain Disinfection.
• Prepared to take on roles of First Aider, Safety Rep, and Fire Warden.
• Participate in various maintenance activities within the Production Area.
• Participate in manual packaging operations.
• Represent Production in Quality Audits of Packaging Areas.
• Perform frequent stock checks on all production ‘Kanban’ items to maintain accurate stock information on SAP system.

Experience required

• Practical experience working within manufacturing and packaging environments – Essential.
• Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning, troubleshooting, and validation – Essential.
• Practical experience working on manufacturing execution systems (MES) – Desirable.
• Practical experience working within the pharmaceutical industry – Desirable.
• A growth mindset with a focus on professional self-development.
• A positive attitude and willing to focus your energy on teamwork, emotional leadership, extreme ownership, discretionary effort, positive energy, and resilience.
• Good leadership and interpersonal skills.
• Developed problem-solving and decision-making capabilities.
• Excellent oral and written communication skills.
• Developed attention to detail and an aptitude for neat/clear documentation.