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Details

Quality Systems Specialist


Reference:A005741 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Quality Systems Specialist
Our client, a Cork based pharmaceutical organisation are currently recruiting for Quality Systems Specialist to join their team on a permanent basis. As Quality Systems Specialist you will support the development and implementation of quality systems strategy and activities to support the organisations Medicines Development Unit and Trial Capabilities goals and objectives for assigned countries. You will act as a quality consultant and leader in integrating the quality requirements into the business processes in relation to trial capabilities and will implement the quality plan and ensure consistency between the global requirements and local requirements.

Responsibilities
• Ensure local implementation of the Quality System
• Review regional and/or local SOPs versus global policies. Reviews SOPs documents and provides feedback
• Approve regional and/or local procedures, job aids, forms, templates
• Recommend new procedures or changes to existing procedures where applicable
• Provide quality oversight for compliance to SOPs
• Escalate compliance issues to management locally and globally as appropriate
• Provide support for outsourced activities in alignment with internal standards
• Ensure inspection readiness and compliance to global, regional, and/or local regulations
• Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates
• Perform quality self-assessments
• Facilitate audits and inspections
• Coordinate audit responses including Trackwise system documentation
• Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc
• Ensure the implementation and maintenance of Quality Plans & manage the quality plan
• Document the quality systems requirements ensuring clear accountabilities
• Provide updates to quality and business owners
• Implement and manage Quality Systems
• Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
• Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
• Drive trending of metrics to improve processes and compliance
• Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions
• Monitor completion of deviations, CAPA related to deviations and change controls
• Monitor completion of audit responses through metrics
• Share key learning to drive simplification and replicate best practices in the region and globally
• Coordinate quality improvement initiatives
• Seek and implement simplification and process improvement

Requirements
• Bachelors or Master’s Degree in a science or health care related field, Health care professional, i.e., Pharmacist, Nurse
• Three years’ experience in quality and/or regulatory/clinical operations/medical affairs
• Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (e.g. GCP, GvP)
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple concurrent tasks
• Demonstrated ability to apply risk-based decision making in a regulated environment
• Additional Skills/Preferences
• Demonstrated ability to work in a global environment

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252