22045 – QC Planner – Carlow Contractor

This is an 11 month contract with a view to extension

Purpose

The QC planner supports the planning of QC activities in the QO Laboratory from the start to end planning (sample receipt to release) including capacity models.
This includes demands from multiple centres production, stability, release, PPQ, contract lab testing all incoming samples, including contract lab testing and adhoc testing as required.
This is a day role based on site (Monday to Friday).

Responsibilities

• Create a rolling QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques. The plan includes personnel and equipment assignment, and the expected sample schedule.
• Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centres – centres production, stability, release, PPQ, contract lab testing all incoming samples, including contract lab testing and adhoc testing as required
• Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.
• Monitor plan execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans if required.
• Review mid to long-term site plans – perform scenario planning based on product and process changes, test method changes, compliance commitments, staffing levels, and equipment capability. Summarise potential laboratory bottlenecks and propose resolutions to ensure continued laboratory capability.
• Monitor and summarise the contract laboratory service-level performance against the agreements and the assigned work. Escalate to contract owner if agreed service level is not achieved.
• Initiates, manage, coordinate change controls and deviations for the QC department as required. Facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs are implemented
• Be an advocate for continuous improvement.
• Drive metrics that appropriately and accurately measure QC performance and take action to mitigate as required.
• Apply project management concepts and techniques, as they relate to planning and test method execution, to meet established delivery timelines

Requirements

• Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment
• Experience in planning and project management
• A minimum of 2-3 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations