Quality Assurance Associate

at  MARKEN

REQUIREMENTS:

• Previous experience in Quality Management Systems with an eye for details
• Knowledge of GxP
• Good interpersonal skills, conflict mediation, sense of urgency to complete assignments on time
• Ability to analyze and work in detail
• Feasibility for home office
• 1+ years of relevant experience, including Quality and Logistics experience in Pharmaceutical/ biotechnology industry experience a plus
• 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.

JOB PURPOSE:

To mainly provide support to the CAPA System, Trainings and Vendor qualification process and records review.

MAIN DUTIES AND RESPONSIBILITIES:

• Maintain the culture of the importance of an integrated quality system within the company
• Trainer of topics related to Quality for vendors and MKN employees
• Support in THE CAPA System
• Completion of investigations via effective investigation of deviations and the development of effective action plans
• Completion of CAPAs and Effectiveness Checks
• Preparing deviation reports
• Support the Vendors Qualification process
• Assist with the “Document Control” process
• Maintain quality policies and procedures in accordance with company requirements
• Evaluate and approve documents according to the organization’s standards and local regulations
• Instructions / SOP creation and review
• Collaborate with the logistics team to monitor the entire process, ensuring the effectiveness and compliance of all operations
• Support quality audits and client’s Marken qualification processes