Quality Assurance Specialist

1 maand geleden

Lijnden, Noord-Holland, Nederland Marken Voltijd
Job Title: Quality Assurance Associate

Description

Job Purpose: The Quality Assurance Associate is responsible for ensuring the implementation and maintenance of Marken's Quality Management System (QMS) and compliance with relevant regulations and customer requirements.

Main Duties and Responsibilities:

  • Implement and maintain company's quality systems at the facility, in compliance with Marken's Global Quality Management System (QMS) requirements.
  • Interact with clients on Quality Assurance (QA)/GxP related matters.
  • Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
  • Oversee an internal audit schedule and perform internal audits, including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).
  • Perform audits of external service providers as part of the vendor selection process.
  • Host client audits and regulatory inspections, manage the audit report responses, and act as Marken's main representative.
  • Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives.
  • Identify relevant GxP/Quality related training needs and deliver or make them available where required.
  • Manage the change control.
  • Ensure that the Marken Quality System and GxP Program are implemented and maintained.
  • Assist in the evaluation of Marken-designated vendors and/or out-sourced activities.
  • Ensure the accuracy and quality of records and documents.
  • Monitor that training for all personnel is conducted and documented.
  • Coordinate and promptly perform any recall activity.
  • Participate actively in all internal Quality and/or designated meetings.
  • Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.

Requirements:

  • Knowledge of Good Manufacturing Practice, Good Storage Practice, and Good Distribution Practice guidelines.
  • 2+ years of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
  • Associate degree and/or equivalent university degree/certifications.
  • Knowledge of local regulations.
  • Previous experience in Quality Management Systems with an eye for details.
  • Excellent written and oral communication skills.
  • Fluent in English and Dutch.
  • Good interpersonal skills.
  • Organized, methodical, and efficient approach to work.
  • Proficient use of Microsoft Office.

About Marken:

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.

Mission: Moving Our World Forward by Delivering What Matters.

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