Associate Quality Auditor
At MSD Animal Health Boxmeer a large diversity of biological and pharmaceutical products are produced, tested, packed and released. The Product Surveillance department as part of the Quality Organization Boxmeer is responsible for product surveillance according to GMP (Good Manufacturing Practices) requirements and operates as a Center of Excellence. The department warrants that product issues with possible market and supply impact are followed up with the highest priority. The processes are designed and continuously improved according to MPS (Merck Production System) principles.
As an Associate Product Surveillance you will work within the Quality department. As part of the team, you will monitor, trend and assure the Product Quality process performance, manage the product quality systems (e.g. complaints, stability study management), identify product deviations/ trends, investigate deviations and escalate product issues.
- Managing the general stability protocols and OnGoing Stability year plan;
- Follow up regulatory commitments regarding stability testing;
- Evaluation of stability profiles and perform trend analysis;
- Coordination and documentation of initial stability Out of Specifications investigations (including Trackwise);
- Gathering data and writing of Product Quality Reports;
- Identify product and/ or process improvements;
- Managing the product quality complaint system;
- Escalation of significant product quality complaints.
- After a training period you are expected to work independently.
- HBO level: several years of experience working with pharmaceutical products/ processes and Quality (No Master or PhD Applicants);
- Good team player but able to work independently as well;
- Experience with GMP;
- Ability to manage assigned tasks within given time lines and available resources;
- Knowledge of internal and external compliance requirements and quality guidelines;
- Results oriented and eager to learn;
- Customer focused, process oriented and data driven;
- As a person you work accurate, and have a pro-active attitude;
- Strong oral and written communication skills in English and Dutch
If this position is something that you want to do, and if you believe you have the right qualifications and experience required for the role, please do not hesitate and send us an e-mail with your most recent CV and short motivation letter to: j.vanbaalen(@)progressive-nl.com