We are seeking a Quality Assurance Officer for one of our international bio-pharmaceutical clients located in Belgium.
In collaboration with the appropriate management, the QA Officer is responsible for setting up and maintaining an effective quality management system.
The QA Officer:
- Ensures that operations related to the packaging of finished pharmaceutical products comply with national and/or international regulations and guidance (GMP).
- Ensures that registered finished products are produced and supplied to markets in accordance with company quality standards.
Main responsibilities:
- QA support for projects defined by the packaging department
- Support for QA projects defined by QA management
- Support for customer audits and inspections related to packaging
- Support for the investigation of market complaints with the responsible pharmacists
- Monitoring of quality deviations, temporary and permanent change control, CAPA
- Drafting and follow-up of annual quality reviews of packaging lines
- Review and approval of packaging and quality assurance procedures
- Review and approval of validation documents for cleaning premises and packaging equipment
- Review and approval of process validation documents
- Review of various quality documents such as metrological specifications, engineering plans, risk analysis, training matrix, coaching, etc.
Qualifications
- Knowledge of GMP and cGMP regulations experience in the pharmaceutical industry of approximately 2 years.
- Knowledge of QA Packaging (blistering, potting, assembly of syringes into combined products) is an asset.
- Certification as a Qualified Person in Belgium according to the Royal Decree of 14 December 2006 is an asset.
- Knowledge of written and spoken English.
- Good oral and written communication skills.
