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Quality Assurance Officer

Quality Assurance Officer

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Quality Assurance Officer

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.

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