QA Officer - Antwerpen, België - Immunodiagnostics System Ltd

Immunodiagnostics System Ltd

Geverifieerd bedrijf

Antwerpen, België

1 week geleden

Geplaatst door:

Sophie Dubois

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Beschrijving

QA Officer:

QA/RA - Belgium:

Department:
QA/RA

Type:
Permanent

Based:
Hybrid

Salary:
Competitive

Closing Date: 04/06/2024

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.

The Liege site was founded as a spin off from the University of Liege in 1989 and now houses 75 employees spread across operations, R&D and administrative functions.

It is centre of excellence for the production and development of IDS automated assays and ancillaries for use on the IDS range of analysers.

Here, we produce around 170,000 assay kits per year and have five R&D teams working on development projects related to automated assays.

Working collaboratively with our QA/RA team, as a Quality Assurance Officer you will: manage our Quality Management System and implement and maintain robust quality assurance systems that underpin our research, development, and manufacturing processes.

Your meticulous attention to detail will be crucial in identifying and addressing any deviations or challenges, ensuring that our products consistently meet and exceed industry standards.

Principle Accountabilities

Review and manage documentation for products and materials, including specifications and operational documents.
Ensure production and packaging records are accurate and products are released appropriately.
Maintain document organisation and oversee document changes and approvals.
Assist in drafting procedures, protocols, and reports.
Archive quality and regulatory documents.
Coordinate resource needs for the department.
Monitor and report on quality indicators and KPIs.
Respond promptly to customer inquiries and complaints.
Manage claims database and incident reporting.
Validate product databases and participate in supplier monitoring and evaluation.
Ensure compliance with manufacturing and documentation standards.
Oversee equipment qualification and validation processes.
Develop and conduct quality training.
Participate in GMP training and postmarket surveillance reviews.
Support validation and transfer activities.
Lead or participate in investigations and risk analyses for complaints or deviations.
Implement corrective actions for quality issues.
Notify QA manager of significant nonconformities or product issues.
Contribute to process improvement initiatives and internal audits.
Supervise or implement process and design changes.