Description
SummaryOne of our key clients in Ireland is looking for an experienced individual in laboratory equipment qualification document preparation in a multiproduct Biotech facility.
Key Responsibilities
- Qualification of new laboratory analytical equipment of a new start-up laboratory.
- Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria for the QC Laboratory.
- Maintain validation related metrics and reports performance to management.
- Writing and executing equipment qualification protocols and subsequent summary reports.
- Analysis and review of validation data to be compiled for validation summary reports.
- Troubleshoot issues encountered during qualification and ensure timely reporting of deviations.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits and approves change control and SOPs.
- Collaborates with functional departments to resolve issues.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation within the company’s SOPs.
- Partner with the application owners and system implementation teams to ensure CFR Part 11 Compliance
Key Requirements
- Significant recent project based experience writing of equipment qualification doc prep such as Risk Assessments, IQ, OQ, Summary Reports, and Trace Matrices.
- Expertise and knowledge on project based risk, complexity, and other relevant factors are required within regulated industries.
- Background within the biotechnology or pharmaceutical industry.
- Proactive, “hands on” mentality, able to hit the ground running and work independently.
- A practical working knowledge of validation, quality assurance, information systems, and risk management best practices.
- Knowledge of GxP (GCP preferred) and CFR Part 11.
- Must be well organised and willing to work as part of a team.
- Excellent communication, interpersonal skills, and customer focus.