Quality Assurance Associate Manager

4 weken geleden

Lijnden, Noord-Holland, Nederland Marken Voltijd

About the Role:

We are seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will be responsible for ensuring that all quality-related activities are conducted in accordance with Marken's Global Quality Management System (QMS) requirements.

Job Description:

  • Implement and maintain company's quality systems at the facility.
  • 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.
  • Perform audits of external service providers as part of the vendor selection process.
  • Host client audits and regulatory inspections.
  • Manage issues and CAPA plans.
  • Identify relevant GxP/ Quality related training needs.
  • 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.

Responsibilities:

  • Perform QA visual/physical inspection of pharmaceutical products.
  • Review and release of incoming material receipts.
  • Verify and approve label printing process and additional labelling/ repackaging activities.
  • Perform the QA activities required Solo (warehouse movement, inventory status control).

About You:

  • You should have knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines.
  • A minimum of 2 years of experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
  • An associate degree and/or equivalent university degree/ certifications.
  • Knowledge of local regulations.
  • Previous experience in Quality Management Systems.
  • 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.

Estimated Salary Range:$80,000 - $110,000 per year

About Marken:Marken is a leading provider of logistics services for clinical trials, cell and gene therapy logistics, and home healthcare services.

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