In collaboration with the appropriate management, the
QA Packaging and medical devices Officer is responsible for the implementation and maintenance of an effective quality management system at the company’s site:
- Ensuring that operations related to the packaging of finished pharmaceutical products comply with national and/or international regulations and guidelines (GMP), as well as the company quality policies
- Ensuring that registered finished products are produced and supplied to markets in accordance with the company quality standards
- Proactively assisting operations in identifying, developing, and implementing quality improvements and operational excellence in response to business requirements, technical changes, and regulatory requirements
- Monitoring of quality deviations, temporary and permanent change control, CAPA
- Support for market complaint investigations with responsible pharmacists
- Writing and follow-up of annual quality reviews of packaging lines
- Support for OOS (Out of Specification) investigations on packaging accessories
- Review and approval of packaging and quality assurance procedures
- Review and approval of qualification documents for packaging equipment
- Review and approval of cleaning validation documents for premises and packaging equipment
- Review and approval of process validation documents
- Support for customer audits and inspections related to packaging
- Review of various quality documents such as metrological specifications, engineering plans, risk analysis, training matrix, coaching, etc.
- QA support for projects defined by the packaging department
- Support for QA projects defined by QA management.