Compliance Coordinator
2 months ago
GxP Audit and Inspection Coordinator - Contractor (6 months)
Need to be based in the UK, Belgium, Netherlands
We are partnering with a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.
We are seeking a detail-oriented and proactive GxP Audit and Inspection Coordinator to join our team for a 6 month period (possible extension). The ideal candidate will have a strong life sciences background and a proven track record in biotech, pharmaceutical, or Contract Research Organization (CRO) settings. This role involves supporting the audit and inspections department in ensuring compliance with industry standards and regulations from an operational standpoint.
In this role, your principal accountabilities are to:
- Assist the audit and inspections department with logistical coordination, documentation management, and operational activities related to internal and external audits and inspections.
- Ensure that all operational processes are in alignment with Good Practice (GxP) guidelines.
- Collaborate with internal and external stakeholders to resource and schedule audits, track timelines, generate Corrective and Preventive Action (CAPA) Plans and manage follow-up actions to closure.
- Provide day-to-day support to internal stakeholders, ensuring seamless operations and adherence to audit and CAPA plan timelines.
- Maintain accurate records of all audit and inspection activities and produce reports summarizing audit and inspection findings and operational insights.
- Support the preparation and logistics of regulatory authority inspections, as needed.
Job requirements
Who are you ?
- Bachelor's degree in Life Sciences or a relevant field.
- Minimum of 3-4 years of experience in a Biotech, Pharmaceutical or CRO environment with responsibilities related to GxP compliance.
- Knowledge of GxP areas such as GMP, GDP, GCP, GLP and familiarity with EU, US and RoW regulations.
- Ability to work independently in a fast-paced environment, adjusting priorities as needed.
- Project management skills and the ability to multi-task.
- Proven ability to collaborate cross-functionally with internal and external stakeholders.
- Demonstrated excellent interpersonal and communication skills.
- Fluent in written and spoken English, with strong technical writing skills.
- Location: UK, France, Belgium, Netherlands, Switzerland (remote role).
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