Quality Assurance Director

18 hours ago


Sundbyberg Municipality, Sweden BioLamina AB Full time
Job Description

At BioLamina AB, we are seeking a highly skilled Quality Assurance Director to join our quality department. In this role, you will be responsible for establishing and maintaining internal quality procedures, standards, specifications, and systems.

You will oversee the administration and continuous development of our Quality Management System (QMS) while supporting other departments to ensure that our operations meet all defined quality requirements.

Our quality management system adheres to the ISO 9001:2015 standard, with a commitment to continuously enhancing our standards for the future.

Key Responsibilities:

  • Establish and maintain internal quality procedures, standards, specifications, and systems.
  • Oversee the administration and continuous development of our Quality Management System (QMS).
  • Support other departments to ensure compliance with quality requirements.
Qualifications & Requirements

The ideal candidate should have the following qualifications:

  • A bachelor's or master's degree in a relevant field.
  • At least two years of experience working in a regulated environment, with expertise in protein manufacturing, cell processing, and analysis.
  • Hands-on experience with deviation investigations.
  • Proficiency in writing change controls (CC) and CAPA.
  • Proficiency in both written and spoken English.


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