We are seeking an experienced NPI Quality Assurance Specialist to support our 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.
Job Description:
The QA Specialist will report directly to the QA Supervisor and be responsible for managing day-to-day activities to ensure compliance with our established Quality Management System, which is based on ISO 9001:2015. This includes supporting product realization in a GMP environment, managing quality metrics, implementing revised quality metrics, and managing CAPA and deviation processes.
* Manage daily activities to ensure compliance with the Quality Management System
* Support product realization in a GMP environment
* Manage, update, and communicate monthly metrics
* Implement revised quality metrics
* Manage CAPA and deviation processes
* Coordinate deviation investigations
* Support Subject Matter Experts in addressing findings
* Mentor Quality Assurance associates
* Manage internal Audit program
* Lead monthly quality audits of each area
* E nsure 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
* Provide regular updates to the Quality Supervisor
Requirements:
To be successful in this role, you will need:
* Bachelor's Degree in a Science Related Discipline
* Minimum 6 years' experience in a Pharmaceutical GMP environment (desirable)
* Good knowledge of current regulatory requirements and working knowledge of ISO 9001:2015
* Knowledge of EXCiPACT and IPEC regulations (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 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
Estimated Salary:
€60,000 - €80,000 per annum, depending on experience.