Job Summary
We are seeking a skilled Packaging and Medical Devices Expert to join our team at Jefferson Wells Belgium.
About the Job
In this role, you will be responsible for implementing and maintaining an effective quality management system at our site.
Key Responsibilities
* Quality Management System: Implement and maintain an effective quality management system at our site.
* Regulatory Compliance: Ensure compliance with national and international regulations and guidelines (GMP) as well as company quality policies.
* Quality Improvements: Proactively assist operations in identifying, developing, and implementing quality improvements and operational excellence in response to business requirements, technical changes, and regulatory requirements.
* Deviations and CAPA: Monitor quality deviations, temporary and permanent change control, and CAPA.
* Market Complaints: Support market complaint investigations with responsible pharmacists.
* Annual Quality Reviews: Write and follow up on annual quality reviews of packaging lines.
* OOS Investigations: Support OOS (Out of Specification) investigations on packaging accessories.
* Procedure Reviews: Review and approve packaging and quality assurance procedures.
* Equipment Qualification: Review and approve qualification documents for packaging equipment.
* Cleaning Validation: Review and approve cleaning validation documents for premises and packaging equipment.
* Process Validation: Review and approve process validation documents.
* Customer Audits: Support customer audits and inspections related to packaging.
* Quality Document Review: Review various quality documents such as metrological specifications, engineering plans, risk analysis, training matrix, coaching, etc.
* Project Support: QA support for projects defined by the packaging department and QA projects defined by QA management.
Requirements
* Scientific Master's Degree: A scientific master's degree is required.
* Experience: Approximately 4 years of experience as an on-site QA in a pharmaceutical production environment.
* Languages: Fluency in French and English is required.