
Compliance and Regulatory Affairs Manager
15 hours ago
We're seeking an experienced Product Quality Manager to join our team 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.
The ideal candidate will have at least 5 years of experience in the pharmaceutical or medical devices industry and possess strong alignment with our values: professionalism, honesty, accuracy, and integrity.
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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Regulatory Affairs and Compliance Professional
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