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

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