Quality Planner

Orion Group Life Sciences are currently recruiting a QC Planner on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. Days role, onsite.

Functions:

• 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

Qualifications/Education

• 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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.