QA Officer - Brussels, België - Immunodiagnostics System Ltd

Immunodiagnostics System Ltd

Geverifieerd bedrijf

Brussels, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

QA Officer:

QA/RA - Belgium:

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.

Job Purpose

We have an excellent opportunity available for an experienced QA Officer to join our Quality team at our Liege site.

In this role, you will work collaboratively with your team and cross functionally to successfully manage the quality management system through robust processes.

You will be involved in a wide variety of tasks from analysing quality documents, to writing specifications, creating training and playing an active role in making process improvements.

Principal Accountabilities

Review all documentation and procedures relating to products and materials (Specifications) relating to raw materials, intermediate products and finished products, as well as documents relating to kit manufacturing, packaging and analysis operations.
Checking production and packaging records and making products available
Centralising requests for changes, creation and deletion of documents, submitting them to a member of the QA department for approval or approving them and filing the completed forms.
Ensuring compliance with good documentation practice when creating/revising documents.
Assisting with the drafting of procedures, protocols, reports and amendment forms.
Collecting and processing information for quality indicators, quality meetings and management reviews.
Monitor KPIs, collect data to keep KPIs up to date, carry out trend analyses.
Keep the claims database and associated directories up to date
Play an active role in analysing and resolving complaints in line with customer and supplier expectations.
Participating in the registration, qualification and evaluation of suppliers.
Ensuring the implementation of good manufacturing practice and documentation rules.
Set up and manage the equipment qualification process and manage the master equipment validation plan (maintenance and qualification)
Write/review specifications (+ Design Qualification), protocols and reports as part of validation or qualification activities (equipment, computerised systems)
Ensuring that equipment procedures are in place (use, qualification, maintenance)
Prepare training materials and run quality training courses
Participate in the Post Market Surveillance (PMS) review
Participating in process/product validation and transfer activities and review related reports.
Leading/participating in/reviewing investigations and risk/impact analyses as part of the handling of complaints, deviations, modifications and outofspecification results/products
Implementing and monitoring corrective actions in response to complaints, deviations, modifications and outofspecification results/products
Play an active role in improving processes
Carry out and monitor internal audits
Participate in the management and coordination of production