Quality Manager Pharmaceutical Industry

16 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
About Our Company

Karo Healthcare is a dynamic and growing consumer health company dedicated to making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories, we own and sell over 80 brands in about 90 countries.

We're committed to empowering people to make intelligent health decisions and are rapidly heading towards a €1 billion European leadership position in consumer health under EQT ownership.

As a Product Quality Manager, you will be part of our exciting journey and contribute to 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.
Authorities:
  • 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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