Description
Title:
Quality Assurance Associate (m/f/d)
Job Purpose:
To mainly provide support to the CAPA System, Trainings and Vendor qualification process and records review.
Main Duties and Responsibilities:
1. Maintain the culture of the importance of an integrated quality system within the company
2. Trainer of topics related to Quality for vendors and MKN employees
3. Support in THE CAPA System
4. Completion of investigations via effective investigation of deviations and the development of effective action plans
5. Completion of CAPAs and Effectiveness Checks
6. Preparing deviation reports
7. Support the Vendors Qualification process
8. Assist with the “Document Control” process
9. Maintain quality policies and procedures in accordance with company requirements
10. Evaluate and approve documents according to the organization's standards and local regulations
11. Instructions / SOP creation and review
12. Collaborate with the logistics team to monitor the entire process, ensuring the effectiveness and compliance of all operations
13. Support quality audits and client’s Marken qualification processes
Requirements:
14. Previous experience in Quality Management Systems with an eye for details
15. Knowledge of GxP
16. Good interpersonal skills, conflict mediation, sense of urgency to complete assignments on time
17. Ability to analyze and work in detail
18. Feasibility for home office
19. 1+ years of relevant experience, including Quality and Logistics experience in Pharmaceutical/ biotechnology industry experience a plus
20. Finishing or recently graduated of a bachelor related to Pharmacy or similar
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
Moving Our World Forward by Delivering What Matters.