The Operator for the Packaging Operations is responsible for the day-to-day manufacturing activities completed at the Dublin Facility. They are responsible for ensuring that all manufacturing activities are completed as per approved Standard Operating Procedures (SOP's), Protocols and Batch Records in a safe manner and in compliance with current Good Manufacturing Practices (cGMP).
- Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
- Perform day-to-day manufacturing and cleaning activities to meet schedules while maintaining a high level of GMP compliance.
- To aid with troubleshooting and resolving operational problems during packaging.
- Ensure all documentation is completed to the required standard and within the specified timelines.
- Review batch records and other manufacturing process records as required
- Routinely draft and revise standard operating procedures and master batch records.
- To aid in deviation investigations and closures.
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
- Maintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business.
- Support Regulatory licensure activities, including agency inspections.
- Report to Area Supervisor on a regular basis online performance and report any issues that need to be resolved.
- To train and be cross functional across all manufacturing areas of the packaging and warehouse facility.
- To perform any other task or duties as assigned by Area Supervisor.
Qualifications & Education
- Third Level qualification in a scientific or engineering discipline or equivalent experience would be desirable
- 2-5 years' experience in Packaging Operations in a GMP environment.
- Must be able to work within and adapt to complex electronic systems such as SAP.
- Experience with warehouse equipment and systems preferred.
- Should be knowledgeable of regulatory and GMP requirements.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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