Product Quality Manager Professional

12 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
About the Role

Karo Healthcare is a dynamic and rapidly growing company focused on empowering individuals to make informed health decisions. With a diverse portfolio across seven categories, we own and sell over 80 brands in approximately 90 countries. Our core values include professionalism, honesty, accuracy, and integrity.

Key Responsibilities
  • Evaluate, qualify, manage, and control suppliers while ensuring compliance with Karo's Global QMS.
  • Take on project leadership roles for select projects and contribute to setting up structures for a project-driven work environment within the QA function.
  • Develop compliant and efficient processes to verify supplier control in the Karo Global QMS.
  • Ensure effective compliance to global processes and foster relationships with Karo's supplier base, working collaboratively with the QA and operations teams.
  • Manage Contract Manufacturing Organizations (CMOs) in accordance with GDP and GMP as well as Directive 2001/83/EC, ensuring product compliance prior to release and after any deviations in production.
  • Act as a process owner for some of the Global QA team's processes.
Authorities and Accountabilities
  • Ensure product compliance with Directive 2001/83/EC in outsourced activities.
  • Audit planning, lead auditor, and audit report sign-off.
  • Participate in internal audit programs as an auditor.
  • Approve and close deviations.
  • Approve and close change controls.
  • Authorize PQRs, specifications, analytical methods, stability protocols, and reports, manufacturing instructions, validation protocols, and reports issued by CMOs.
  • Issue and/or approve regulatory documents (Module 3).
  • Authorize suppliers.
  • Co-sign QA Agreements when applicable.


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