GxP Quality Assurance Expert

3 days ago


Stockholm, Stockholm, Sweden Clevry UK Ltd. Full time

Job Description:

Clevry UK Ltd. seeks a seasoned Senior GxP Auditor to oversee the development and execution of a global risk-based audit strategy, driving compliance with GMP/GDP regulations.

Key Responsibilities:

  • Strategy Development: Create and implement a comprehensive global audit strategy, emphasizing quality and regulatory excellence.
  • Audit Leadership: Guide external GxP audits of CMOs, suppliers, and service providers, promoting timely completion and effective follow-up.
  • Internal Audit: Conduct internal audits and self-inspections, fostering an environment of continuous improvement.
  • Regulatory Guidance: Offer authoritative advice on regulatory compliance, empowering business growth through best practices.
  • Critical Issue Resolution: Swiftly escalate and resolve critical findings, ensuring seamless implementation of CAPAs.
  • Performance Analysis: Compile audit status reports, highlighting trends and performance metrics that inform strategic decision-making.
  • Collaboration: Support authority inspections and partner audits, demonstrating seamless integration with global partners.
  • Knowledge Management: Maintain expert-level proficiency in FDA, EU, and ICH regulations, staying abreast of evolving regulatory requirements.
  • Process Optimization: Author SOPs that streamline GxP audit processes, minimizing operational hurdles.
  • Business Expansion: Leverage GxP compliance consulting to drive business growth through strategic initiatives and process improvements.

Eligibility Requirements:

  • Life Sciences University Degree.
  • At least 10 years of experience in the pharmaceutical industry with GMP/GDP responsibilities.
  • Strong background in GMP/GDP audits and inspections.
  • Desirable: Experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing.


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