Compliance Specialist

8 hours ago


Stockholm, Stockholm, Sweden Clevry UK Ltd. Full time

Job Overview:

Clevry UK Ltd. is a leading pharmaceutical company seeking an experienced Senior GxP Auditor to join our team.

About the Role:

This key position plays a critical role in developing and supporting a global, risk-based audit strategy while ensuring compliance with GMP/GDP regulations.

Responsibilities:

  1. Develop Audit Strategy: Collaborate with cross-functional teams to maintain the highest standards in quality and regulatory compliance.
  2. Conduct External Audits: Plan, lead, conduct, document, and follow up on external GxP audits of CMOs, suppliers, and service providers.
  3. Internal Audits: Perform internal audits/self-inspections as Lead or Co-Auditor.
  4. Regulatory Guidance: Provide regulatory guidance and recommendations for compliance.
  5. Escalation: Escalate critical findings and ensure appropriate corrective and preventive actions (CAPA).
  6. Reporting: Prepare regular audit status reports, including audit trends and performance metrics.
  7. Support Authority Inspections: Support authority inspections and partner audits.
  8. Maintain Expertise: Maintain expertise in FDA, EU, and ICH regulations as well as internal quality standards.
  9. SOP Author: Act as an SOP Author for GxP audit-related SOPs.
  10. GxP Consulting: Provide GxP compliance consulting for training, continuous improvement projects, and task forces.

Qualifications & Experience:

  1. University degree in Life Sciences or a related field.
  2. Minimum 10 years' experience in the pharmaceutical industry with GMP/GDP responsibilities.
  3. Strong background in GMP/GDP audits/inspections.
  4. Experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing (Drug and Finished Products); Drug Substance experience is preferred.

Skills & Attributes:

  1. Excellent knowledge of EU/US/RoW GMP/GDP regulations.
  2. Strong verbal and written communication skills.
  3. Proficiency in document management systems.
  4. Structured, detail-oriented, and collaborative mindset.
  5. Ability to multi-task and manage priorities effectively.


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