Process Improvement Specialist
2 weeks ago
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in the US, with global operations worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
Role Functions:
- We are seeking a highly motivated Process Improvement Specialist to join our Downstream Integrated Process Team (IPT) in Dublin, Ireland.
- The successful candidate will work closely with our team to ensure on-time delivery of production schedules while maintaining alignment with site safety and quality standards.
- This role requires effective oversight of material management, ensuring quality and delivery metrics are consistently met.
- Responsibilities include owning quality investigations from identification through root cause analysis.
- Oversight of day-to-day production quality metrics is also required, including on-time documentation closure, line clearance, and material management as per area SOPs.
- Driving continuous improvement projects related to schedule, equipment, and delivery capability within the IPT is a key aspect of this role.
- This position acts as a link between shift operations teams and day teams, ensuring standardization and integration between all IPT teams.
- Audit readiness in the BDS and driving a permanent audit readiness culture within the team are critical responsibilities.
- This role involves directing Root Cause Analysis (RCA) sessions for safety and quality-related events, driving actions to closure with appropriate corrective/preventive measures.
- Leading/supporting area change controls, CAPAs, QSAT Actions, and completing documentation updates as required is an essential part of this job.
- Providing ongoing coaching and support to cross-functional team members, sharing process and operational best practices, is a vital responsibility.
- This role includes acting as day operations member on process-centered teams (PCT), working with technical operations and shift operations to identify, perform RCA, and develop corrective/preventive actions for issues as they occur.
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