Senior Quality Manager

21 hours ago


Sundbyberg Municipality, Sweden BioLamina AB Full time
Role Summary

At BioLamina AB, we are seeking a Senior Quality Manager to join our quality team. In this role, you will be responsible for releasing LN and CAP, handling deviations, change controls, and CAPA related to product release.

Key Responsibilities:

  • Release of LN and CAP.
  • Handling deviations, Change Controls (CC), and CAPA related to product release.
  • Conduct quality assurance review and approval of key documentation, including but not limited to deviations, change controls, CAPA, studies, specifications, and statements.
  • Provide quality training and guidance to personnel.
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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