NPI Quality Assurance Specialist
We are seeking an experienced NPI Quality Assurance Specialist to join our team at an established Pharma-related manufacturing company in Laois, Ireland.
Key Responsibilities:
* Manage day-to-day activities to ensure compliance with the established Quality Management System.
* Support product realization in a GMP environment.
* Manage, update, and communicate monthly metrics.
* Implement revised quality metrics.
* Manage the Corrective and Preventative action (CAPA) and deviation processes.
* Coordinate deviation investigations.
* Support Subject Matter Experts (SMEs) in addressing findings.
* Mentor Quality Assurance associates.
* Manage internal Audit program.
* Lead monthly quality audits of each area.
* Ensure controlled areas operate to the required standards.
* Participate in and implement continuous improvement initiatives.
* Provide support and expertise for inspection readiness.
* Update internal procedures as necessary.
* Support customer and regulatory audits.
* Support projects as required.
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 essential.
* Knowledge of EXCiPACT and IPEC regulations is an advantage.
* Experience in Quality Risk management.
* 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 relationships with internal and external stakeholders.
* Excellent written and oral communication skills.
* Strong leadership and conflict resolution skills.
* Able to foster collaborative, cross-department relationships to meet common objectives.