NEW ROLE : NPI Quality Assurance Specialist required for an established Pharma related manufacturing company in Laois. Our client offers a full range of products to the pharma/bio pharma and biotech sector in Ireland. Reporting directly to the QA Supervisor, the QA Specialist will support the Quality Management System, ensuring compliance with established procedures and quality/business requirements. Knowledge of current regulatory requirements and working knowledge of ISO 9001:2015 essential
Role
• Responsible for managing day-to-day activities to ensure compliance to the established Quality Management System.
• Supporting product realization in a GMP environment.
• Managing, updating, and communicating monthly metrics.
• Implementing revised quality metrics.
• Managing the Corrective and Preventative action (CAPA) and deviation processes.
• Co-ordinating deviation investigations
• Supporting SME’s in addressing findings.
• Mentoring Quality Assurance associates.
• Manage internal Audit program.
• Leading monthly quality audits of each area.
• Ensuring controlled areas operate to the required standards.
• Actively participate and implement continuous improvement initiatives.
• Provide support and expertise for inspection readiness.
• Update internal procedures as appropriate.
• Support customer and regulatory audits.
• Support projects as required.
• Providing regular updates to the Quality Supervisor.
Requirements
• Bachelor's Degree in a Science Related Discipline.
• Min 6 years’ experience Pharmaceutical GMP environment, desirable
• Good knowledge of current regulatory requirements and working knowledge of ISO 9001:2015 is required.
• Knowledge EXCiPACT and IPEC regulations an advantage.
• Experience in Quality Risk management
• Desired competencies include strong attention to detail focused on delivery of a Quality product.
• Good organizational and presentation skills, ability to communicate Quality Metrics to management.
• Strong interpersonal and communication skills, ability to maintain positive, Quality focused relationship with internal and external stakeholders.
• Excellent Written and oral communication skills.
• Strong leadership and conflict resolution skills.
• Ability to foster collaborative, cross department relationships to meet common objectives.
For more information, please reach out to [email protected]
