Job Description
This role is part of our team at Jefferson Wells Belgium, where we are looking for a skilled Quality Assurance Specialist.
About the Job
We are seeking a highly motivated and experienced QA professional to join our team as a Packaging and Medical Devices Expert. As a key member of our team, you will be responsible for implementing and maintaining an effective quality management system at our site.
Responsibilities
* Ensure Compliance: Ensure that operations related to packaging comply with national and international regulations and guidelines (GMP) as well as company quality policies.
* Product Supply: Ensure that registered finished products are produced and supplied to markets in accordance with company quality standards.
* 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.