
Senior Quality Assurance Manager
1 week ago
Job Summary
We are seeking an experienced Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for providing quality assurance support and oversight to our Irish operations team.
About the Role
- Provide quality assurance support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, QMS and any other applicable regulations/standards.
- Review and approve quality documentation generated in Irish operations e.g., including but not limited to Deviations, CAPAs, change controls, logbooks, SOPs, risk assessments, OOO/OOT, temperature logs, etc.
- Support a “Quality on the Shop Floor” culture through completion of facility walk rounds (including gowning into sterile facility) to maintain a high level of compliance and QA oversight by working closely together with operations ensuring proactive approach to identify potential issues and minimise impact.
- Generate and prepare quality documents e.g., SOP's and controlled documents e.g., SOPs and Training Material.
- Ensure compliant and adequate systems are in place to monitor investigations, CAPAs, audits and Quality Review Boards.
- Support the preparation, execution and follow up on regulatory inspections.
- Perform self-inspections in a timely manner as per plan.
- Perform external audits of key suppliers and service providers where required.
- Review QA for the eQMS system documents.
- Gather data on status/performance of the Quality Management Systems to support Quality Council Meetings.
- Aid in the management and proactively initiate and support continuous improvement of the Quality Management System.
- Deliver GxP compliance training to operational areas.
What We Offer
We offer a competitive compensation package, opportunities for professional growth and development, and a dynamic work environment.
About Us
We are a leading organization in the field of [industry]. Our mission is to deliver high-quality products and services that meet the needs of our customers.
-
Quality Assurance Manager
1 week ago
Shannon, Ireland beBeeQuality Full time €40,000 - €52,000Job Title: Quality Assurance ManagerWe are seeking an experienced Quality Assurance Manager to lead our quality management systems and ensure compliance to international standards.Key Responsibilities:Perform root cause analysis on manufacturing quality issues, authoring deviation reports.Collaborate with customers and suppliers to meet their standard...
-
Senior Quality Assurance Expert
5 days ago
Shannon, Ireland beBeeQuality Full time €65,000 - €75,000Seeking a seasoned Senior Quality Assurance Expert to provide oversight and support for the Irish Manufacturing site.Job DescriptionProvide quality assurance and compliance expertise to ensure seamless operations in a regulated environment.Key Responsibilities:Ensure compliance with EU, Irish, and FDA cGxP regulatory requirementsReview and approve quality...
-
Process Quality Assurance Manager
6 days ago
Shannon, Ireland beBeeAnalytical Full time €80,000 - €100,000Job Title: Process Quality Assurance Manager">About the Role: We are seeking a seasoned Process Quality Assurance Manager to lead method lifecycle activities supporting advanced biologic products. You will be responsible for driving excellence in analytical processes and quality standards.">Responsibilities: 1. Lead the development, optimization, and...
-
Quality Assurance Specialist
2 weeks ago
Shannon, Ireland beBeeAssurance Full time €60,000 - €80,000Job Title:Quality Assurance SpecialistAbout the Role:We're seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a crucial role in ensuring the highest standards of quality in our products.Key Responsibilities:Conduct quality inspections and audits to identify areas for...
-
Quality Assurance Specialist
1 week ago
Shannon, Ireland beBeeQuality Full time €50,000 - €80,000Job Role: Quality Assurance SpecialistJob Summary:Evaluate and ensure compliance with Good Manufacturing Practice regulations in the Quality Control department.Support the start-up of a new facility for gene therapy production, including equipment qualification and method validation.Collaborate with cross-functional teams to identify and implement process...
-
Quality Assurance Engineer
4 weeks ago
Shannon, Ireland Ohshima Ireland Limited Full timeThe CompanyOhshima Ireland LTD is currently seeking an experienced Quality Assurance Engineer to join our growing team based in our facility in Shannon, Co. Clare.This organisation has worldwide expertise but also a local presence within our specialized field.This will be a key role in the company and requires someone coming from a fast-paced multi-national...
-
Senior Quality Assurance Specialist
5 days ago
Shannon, Ireland beBeeengineer Full time €60,000 - €80,000Our Quality Assurance team is committed to ensuring the highest level of quality in our products. We are seeking a skilled Quality Engineer who will be responsible for assuring that our products meet established requirements and standards.\
-
Senior Quality Assurance Specialist
7 days ago
Shannon, Ireland beBeeQuality Full time €60,000 - €90,000Job OverviewThis position plays a pivotal role in ensuring the quality and compliance of our manufacturing site.The successful candidate will be responsible for providing quality assurance support and oversight to ensure that all regulatory requirements are met.Providing quality assurance support and oversight to ensure compliance with EU, Irish, and FDA...
-
Biotech Quality Assurance Expert
6 days ago
Shannon, Ireland beBeeQuality Full time €40,000 - €60,000Hiring for a Quality Assurance Specialist to drive quality control processes in a biotech environment.This role plays a pivotal part in ensuring adherence to Good Manufacturing Practice (GMP) standards for the production and release of gene therapy products.Responsibilities include performing routine lab tests, coordinating testing with external labs,...
-
Senior Systems Assurance Manager
2 weeks ago
Shannon, Ireland beBeeData Full time €80,000 - €120,000Quality Assurance DirectorThe successful candidate will lead the implementation of quality standards for electronic systems and data management. This role requires a strong leader who can oversee validation and compliance of computerized systems, conduct inspections and assessments to ensure regulatory adherence.Responsibilities:Implement Quality Standards:...