NPI QA Specialist New

1 day ago


Portlaoise, Ireland CPL Full time

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]



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