Overzicht
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.
This involves:
- 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.
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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.
For MSD Animal Health – Quality organization in Boxmeer (The Netherlands) we are currently recruiting a:
Associate Product Surveillance
- HBO level
- Several years of experience working with pharmaceutical products/ processes and Quality
- Good team player but able to work independently as well
- Experience with GMP
- Ability to manage assigned tasks within given timelines 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
Vacature type:
Categorie: Engineering
Ervaring: Full-time