NPI Quality Assurance Specialist
We are seeking a skilled NPI Quality Assurance Specialist to support our client in Laois, Ireland. Our company offers a comprehensive range of products to the pharma/bio pharma and biotech sector in Ireland.
As a key member of the quality team, you will report directly to the QA Supervisor and be responsible for supporting the Quality Management System, ensuring compliance with established procedures and quality/business requirements.
Key Responsibilities:
* Manage day-to-day activities to ensure compliance with the Quality Management System.
* Support product realization in a GMP environment.
* Develop and communicate monthly metrics.
* Implement revised quality metrics.
* Manage the Corrective and Preventative action (CAPA) and deviation processes.
* Coordinate deviation investigations.
* Provide expertise to SME's in addressing findings.
* Mentor Quality Assurance associates.
* Lead internal Audit program.
* Conduct monthly quality audits of each area.
* E nsure controlled areas operate to the required standards.
* P articipate and implement continuous improvement initiatives.
* Provide support and expertise for inspection readiness.
Requirements:
* Bachelor's Degree in a Science Related Discipline.
* Minimum 6 years' experience in a Pharmaceutical GMP environment.
* Good knowledge of current regulatory requirements and working knowledge of ISO 9001:2015 is required.
* Knowledge of EXCiPACT and IPEC regulations an advantage.
* Experience in Quality Risk management.
* Strong attention to detail focused on delivery of a Quality product.
* Excellent organizational and presentation skills.
* Strong interpersonal and communication skills.
* Excellent written and oral communication skills.
* Strong leadership and conflict resolution skills.