![Clevry UK Ltd.](https://media.trabajo.org/img/noimg.jpg)
Compliance Specialist
8 hours ago
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:
- Develop Audit Strategy: Collaborate with cross-functional teams to maintain the highest standards in quality and regulatory compliance.
- Conduct External Audits: Plan, lead, conduct, document, and follow up on external GxP audits of CMOs, suppliers, and service providers.
- Internal Audits: Perform internal audits/self-inspections as Lead or Co-Auditor.
- Regulatory Guidance: Provide regulatory guidance and recommendations for compliance.
- Escalation: Escalate critical findings and ensure appropriate corrective and preventive actions (CAPA).
- Reporting: Prepare regular audit status reports, including audit trends and performance metrics.
- Support Authority Inspections: Support authority inspections and partner audits.
- Maintain Expertise: Maintain expertise in FDA, EU, and ICH regulations as well as internal quality standards.
- SOP Author: Act as an SOP Author for GxP audit-related SOPs.
- GxP Consulting: Provide GxP compliance consulting for training, continuous improvement projects, and task forces.
Qualifications & Experience:
- University degree in Life Sciences or a related field.
- Minimum 10 years' experience in the pharmaceutical industry with GMP/GDP responsibilities.
- Strong background in GMP/GDP audits/inspections.
- Experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing (Drug and Finished Products); Drug Substance experience is preferred.
Skills & Attributes:
- Excellent knowledge of EU/US/RoW GMP/GDP regulations.
- Strong verbal and written communication skills.
- Proficiency in document management systems.
- Structured, detail-oriented, and collaborative mindset.
- Ability to multi-task and manage priorities effectively.
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