Quality Assurance Specialist Job
We are seeking a seasoned Quality Assurance Specialist to join our team. This role involves providing quality support and oversight for the manufacturing site, ensuring regulatory compliance and product quality requirements are met.
The successful candidate will have a strong background in GMP regulated environments, biotechnology, or related manufacturing. They will be responsible for reviewing and approving quality documentation, supporting the implementation of a local Quality Management System, and ensuring compliance with EU, Irish, and FDA cGxP regulatory requirements.
Key responsibilities include:
* Providing quality support and oversight to the operations team
* Reviewing and approving quality documentation
* SUPPORTING THE IMPLEMENTATION OF A LOCAL QUALITY MANAGEMENT SYSTEM
* Ensuring compliance with EU, Irish, and FDA cGxP regulatory requirements
* Generating and preparing quality documents
* Ensuring compliant systems are in place to monitor investigations and audits
* Supporting regulatory inspections and self-inspections
* Performing external audits of key suppliers and service providers
* Delivering GxP compliance training
Requirements
Experience working in a GMP regulated environment, biotechnology, or related manufacturing is preferred. The ideal candidate will also have experience in operating and improving all aspects of a local QMS, including investigations, change controls, and CAPAs. Additionally, they will possess excellent interpersonal skills, be able to prioritize workload, and demonstrate good organizational and time management skills.
* 10 years of experience working in a GMP regulated environment, biotechnology, or related manufacturing
* Experience in operating and improving all aspects of a local QMS
* Excellent interpersonal skills
* Ability to prioritize workload and manage time effectively