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Job Description
Job Summary: Responsible for managing GMP sampling, raw materials warehousing, receiving, and inventory movements across the site, ensuring compliance with current Good Manufacturing Practices (cGMPs).
As a key member of the team, you will be responsible for executing all tasks associated with WCL processes, including receiving, sampling, and raw material storage. You will also be responsible for quality inspection of incoming consumables, GMP sampling of all site raw materials, and supplying manufacturing areas with required materials in a timely manner.
- Execute all tasks associated with WCL processes, including receiving, sampling, and raw material storage.
- Quality inspection of incoming consumables.
- GMP sampling of all site raw materials, working in an ISO7 (Grade C) area, utilizing Downflow Booths, Fume hoods, Bio-Safety Cabinets, and Nitrogen Overlay processes.
- Supply manufacturing areas with required materials in a timely manner to support the manufacturing schedule.
- Transfer materials and consumables from WCL to Just In Time (JIT) area, then stock JIT accordingly.
- Maintain KANBAN system for consumables within the MPCC building.
- Contribute to the generation of SOPs required for The Warehouse.
- Contribute to all process improvements in The Warehouse.
- Perform cycle counting process for inventory in WCL locations.
- Contribute to the development of SOPs, investigations, CAPAs, and change controls related to materials management activities.
- Work with manager, supervisor, and WCL team to ensure that material management areas and processes are inspection ready at all times.
Key Responsibilities:
- Operate in a safe and responsible manner, promoting a safety culture on site and a safe working environment for all employees.
- Highlight safety concerns as a first priority and escalate any near misses to prevent safety incidents.
- Report all safety concerns to the WCL Supervisor.
- Use appropriate safety and GMP clothing and protective equipment as per training and relevant SOPs.
- Operate all production equipment within the assigned functional area in a safe manner.
- Familiarize yourself with your working environment and have an awareness of emergency procedures in manufacturing production areas and general site.
- Ensure all Safety related training is completed and valid.
Teamwork and Collaboration:
- Work as part of a cross-functional group to facilitate the development and validation of the WCL.
- Participate in regular team meetings/shift handovers.
- Participate in departmental teams, cross-functional teams, programs, or company initiatives to resolve issues and improve site safety, quality, compliance, and performance.
- Represent WCL as a department representative on cross-functional work teams and liaise with and direct other team members or contractors as necessary.
- Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the site plan.
Personal Development:
- Maintain a high level of personal expertise and working knowledge of all aspects of the WCL processes and equipment through continuous training and development.
- Actively manage one's own training plan and maintain ownership of completing the job function training curricula.
- Engage in and support a culture of Continuous Improvement (CI) and Operational Excellence (OPEX) through ownership of improvement for work processes, equipment, and safe work environment.
- Pass on knowledge and learnings to others to promote an environment of continuous development.
Housekeeping and Maintenance:
- Ensure that the very highest standards of housekeeping are maintained as tasks are carried out.
- Participate in Pre-Operational checks.
- Ensure the plant is in an audit-ready state at all times.
Required Competencies:
- Ability to work independently and as part of a team.
- High degree of problem-solving ability and adherence to scheduled timelines.
- Excellent communication skills and ability to work in a cross-functional collaborative environment.
- Excellent focus and attention to detail.
- Good interpersonal skills, attentiveness, and an approachable manner for interactions with inter-departmental colleagues.
Required Qualifications and Experience:
- Leaving Certificate is a minimum requirement, a third-level qualification in logistics and/or manufacturing is preferred.
- A minimum of 2 years' GMP experience. Experience in Biologics manufacturing is preferred.
- Ideally have a working knowledge of computerized production and inventory control systems (SAP) and documentation practices.
- Trained on Powered Industrial trucks, Turret trucks, reach truck, motorized pallets trucks, etc.
- An understanding of regulations handling of hazardous materials.