Job Location
Rotterdam
Job Description
We are seeking our Quality Specialist to support the Go-To-Market Quality Assurance team in order to ensure compliance with all applicable pharmaceutical regulations.
The Quality Specialist should:
Support the Go-To-Market Quality Assurance team to ensure Quality Management System (QMS) is implemented and maintained as the examples below
Preparation of batch release documentation
Training follow-up (onboarding and continuous training and distribution of local documentation for training)
Compile quality KPI (Key Performance Indicators)
Tracking and follow-up on quality system records such as Change Controls, deviations, CAPAs and record handling within P&G quality systems
Follow-up on renewal of Quality Agreement
Support approval/qualification of suppliers/customers
Product Quality Complaint follow-up
Support publication of Quality Management System documentation in P&G quality systems
Support archiving activities
Answer to requests from Customers / Business on ad hoc base
Support preparation of the Product Quality Review assessment and Quality management Review
Raise immediately any concerns to the Qualified Person-Responsible Person as appropriate
support eQMS and Rubix projects as needed
support EU QMR preparation as needed
These activities should always be in full compliance with the Dutch Healthcare current regulations, notably the GxP (GDP, GMP, GCP, GLP, etc.).
Job Qualifications
- Bachelor’s degree in health-related science, life science, pharmacy or medical degree
WORK EXPERIENCE:
Ideally Quality Management System experience or relevant experience in pharmaceutical and/or food industry
ADDITIONAL REQUIREMENTS:
• Strong customer orientation
• Demonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem-solving capabilities
• Ability to work independently and manage time efficiently and effective
• Awareness of cultural differences and impacts of team/personal behavior
• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective
PERSONAL SKILLS:
• Team spirit
• Autonomy
• Prioritization
• Well-organized
• Cross-functional collaboration
Job Schedule
Full time
Job Number
R000118605
Job Segmentation
Recent Grads/Entry Level (Job Segmentation)