
Product Quality Assurance Specialist
12 hours ago
Karo Healthcare is a rapidly growing consumer health company with a wide-ranging portfolio across seven categories. We own and sell over 80 brands in about 90 countries, driven by our core belief in empowering people to make intelligent health decisions.
We're currently looking for a Product Quality Manager to join our office in Stockholm. As a key member of our Quality Assurance team, you will play a crucial role in ensuring the compliance and efficiency of our global quality management system.
Key Responsibilities:- Evaluate, qualify, manage, and control suppliers while acting as a QA representative in Technology Transfer projects.
- Take on project leadership roles and contribute to setting up structures for a project-driven work environment within the Quality Assurance function.
- Ensure compliant and efficient processes for supplier control in the Karo Global QMS.
- Secure efficient compliance to global processes and foster relationships with our supplier base.
- Manage CMOs in accordance with GDP and GMP directives and ensure product compliance after release, including prior deviation handling and follow-up.
- Act as a process owner for some of the Global QA teams' processes.
- Ensure product compliance with Directive 2001/83/EC in outsourced activities.
- Plan, lead audits, and sign off audit reports.
- Participate in internal audits and approve deviations, change controls, PQRs, specifications, analytical methods, and GMP documents.
- Issue and/or approve regulatory documents (Modul 3) and co-sign QA-Agreements when applicable.
- Decide on final disposition of returned, rejected, recalled, or falsified products, and approve returns to saleable stock.
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