QA/RA – UK
IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.
IDS Boldon is the global IDS Headquarters occupying a single, multi-disciplined site.
The site focuses on the manufacture and distribution of manual Immunoassay products. On site Purchasing, Logistics, Production, Quality Control and Process Development departments manage the supply chain, supported by local Sales Support, Quality Assurance, Regulatory Affairs and Finance departments. As Group Headquarters, IDS Boldon also houses all head office functions.
Assist in the maintenance of the IDS Boldon Quality Management System; and to ensure that manufactured product (IVD) is manufactured and distributed in accordance with the appropriate International Standards & Regulations.
- Assist in the maintenance of the IDS Boldon Quality Management System in accordance with appropriate International Standards & Regulations and Group Standards for the manufacture of IVD products at IDS Boldon.
- Complete reviews of batch manufacturing records to ensure adherence to requirements leading to the QA Release of intermediate and final product at IDS Boldon.
- Interface with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to IDS Boldon Production.
- Ensure that products and processes comply with the relevant requirements of the quality management system.
- Evaluate and continually improve Quality Systems to ensure that products and processes meet defined quality standards and comply with the appropriate international standards and regulations.
- Facilitation of non-conformance investigation, root cause analysis and implementation of effective CAPA for process related concerns.
- Assessment and approval of changes to ensure quality impact analysis, risk management and validation activities are identified and carried out.
- Conduct internal quality audits and assist with external audits
- Assist in the investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events.
- Creation, maintenance and approval of all QMS documentation
- Completion and analysis of QA Metrics towards Quality Management Reviews
- QMS document control, including archiving & periodic reviews
- Ensuring the promotion of quality awareness throughout the Company
- Deliver training to build quality awareness
- Release of quarantined materials
- Review, approval and administration of Product Notifications
- Preparation of Post Market Surveillance Reports
- Administration of on-line training system
- Monitor the progress of quality activities on a daily/weekly basis ensuring that there is continuous drive/focus on meeting target dates and KPIs
- Assist with the preparation, execution and completion of validation documentation ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- Compilation of Euratom returns as required
- GCSE level or higher qualifications (OR at least 2-3 years relevant experience)
Skills & Knowledge
- Knowledge of, and experience in the application of, ISO 13485 and other quality management system requirements required under MDSAP
- Good attention to detail; and communication skills both internal and external
- Ability to work as part of a team, departmentally and inter-departmentally
- Ability to work under pressure and to strict deadlines
- Ability to work in an autonomous, self-managed role.
- Good organization and influencing skills
- Experience of applicable regulations for manufacture and distribution of devices in globally
- Knowledge of Quality Systems and their operation would be a benefit
- Very good experience working as an administrator in the manufacturing industry
- Department: Quality and Regulatory
- Based: Boldon - UK
By making an application for us, you agree that the data provided in your application and any obtained in relation to it, including that from any interviews, selection centres or references, will be used by us to process your application and might also be used to help us with any future applications by you. If your application is successful, the data will be used to administer your personnel record.
We will treat your personal data as being confidential and will comply with all applicable UK Data Protection legislation in respect of it.
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