Quality Assurance Manager

5 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
Job Description

Karo Healthcare is a leading provider of healthcare solutions with a strong presence in the European market. We are seeking a highly skilled Quality Assurance Manager to join our team.

The successful candidate will be responsible for ensuring the quality and compliance of our products, working closely with suppliers, manufacturers, and internal stakeholders. This role requires a strong understanding of regulatory requirements, including GDP and GMP, as well as excellent communication and project management skills.

Key Responsibilities:

  • Ensure compliance with global regulations, such as 2001/83/EC
  • Evaluate and manage supplier relationships, including qualification, validation, and audit planning
  • Lead internal audits and participate in external audits as a subject matter expert
  • Approve and close deviations, change controls, and product quality reports
  • Manage and maintain quality records, including PQRs, specifications, and analytical methods
  • Act as a process owner for certain Global QA team processes

Requirements:

  • Bachelor's degree in a scientific or technical field, preferably Master's degree in Pharmacy, Medicine, Chemistry, or Chemical Engineering
  • At least 5 years of experience in the pharmaceutical or medical devices industry
  • Fluency in English is essential; Swedish is a plus
  • Strong alignment with Karo values: professionalism, honesty, accuracy, and integrity


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