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QA Officer
3 months ago
**QA Officer**:
**QA/RA - UK**:
Department: QA/RA
Type: Permanent
Based: Hybrid
**Salary**:
Closing Date: 20/05/2024
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.
Are you passionate about ensuring that innovative in vitro diagnostic (IVD) products meet the highest standards of quality and compliance? We are seeking a proactive individual to champion our Quality Management System (QMS) and Regulatory Affairs efforts, ensuring seamless manufacturing, distribution, and regulatory approval processes.
**Principal Accountabilities**
- Assist in the management of all the QA aspects of Quality Compliance for the manufacture of IVD products.
- The review of manufacturing batch records and the QA disposition of final products.
- Interface with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to production.
- Ensure that products and processes comply with the relevant requirements of the quality management system.
- Evaluate and enhance Quality Systems to ensure that products and processes meet defined quality standards and comply with the appropriate international standards and regulations.
- Facilitation of root cause analysis and implementation of effective CAPA for process related concerns.
- Assessment of change to ensure quality impact analysis, risk management and validation activities are identified and carried out.
- Deliver training to build quality awareness
- Conduct internal Quality audits.
- Assist in the investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events.
- Assist in the creation and maintenance of company quality documentation, such as quality manuals, quality procedures, etc.
- Preparation of QMS documentation; SOPs, QA reports etc.
**Support the Regulatory Affairs team with**:
- The creation and maintenance of Technical files for the IVD Directive/Regulation
- Preparation of regulatory submissions for countries of interest that implement marketing regulations.
- Manage and maintain IVD Device registrations.
- Review all labelling, marketing and training materials for regulatory compliance.
**Skills, Knowledge and Experience**
**Qualifications**
- Bachelors degree (or equivalent) in Biochemistry or similar (OR at least 2-3 years relevant experience)
- Internal Auditor ISO 9001 or ISO13485
**Skills & Knowledge**
- Good attention to detail; and communication skills both internal and exte
