Description

The purpose of the Quality Assurance Associate role is to facilitate, manage, and oversee the implementation of the Marken Quality Management System (QMS) at the site. 

Main Duties and Responsibilities:

• Maintain the culture of the importance of an integrated quality system within the company.
• Facilitate the handling of Quality Issues, escalation of Quality Issues as well as CAPA tracking up to completion of action. 
• Ensuring the accuracy and quality of all records and documents.
• Support the Vendors Qualification process.
• Acting as Quality Assurance representative for customer audits, including the preparing of appropriate materials required within those audits. 
• Maintain quality policies and procedures in accordance with company requirements.
• Evaluate and approve documents according to the organization's standards and local regulations.
• Conducting self-inspection audits for the local or regional Marken facilities. 
• Collaborate with other departments to monitor the entire process, ensuring the effectiveness and compliance of all operations.
• Tracking and overseeing all commitments for actions or changes made by Marken from previous customer audits as well as from internal audits. 
• Train, and help to assimilate new employees. 
• Coordinating the required training activities for all personnel and ensuring appropriate documentation and filing (this will include but is not limited to SOP training, regulatory training and Health and Safety training). 
• Participate actively to the internal quality meeting.

Requirements:

• 1+ years of relevant experience, including Quality and Logistics experience in Pharmaceutical/ biotechnology industry experience a plus.
• Bachelor related to Pharmacy or similar - is a plus.
• Knowledge of GxP.
• Good interpersonal skills, sense of urgency to complete assignments on time.
• Have excellent oral and written communication skills in English.
• Flexible and adaptable to change.
• Client communication skills.
• Must be self-motivated, focused, reliable and responsible. 
• Ability to work independently and as a team.
• Have an interest in the pharmaceutical industry and international transport.

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.

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