GxP Auditor (GCP/PV)

Proclinical are recruiting a GxP Auditor (GCP/PV) for a biotech establishment. This role is on a permanent basis with the ability to work remotely from anywhere in Europe. The client is focused on improving the lives of those who suffer from rare illnesses.

Responsibilities:

• The ideal candidate will assist with the methodical development of an efficient international risk-based audit method and program both internally and externally.
• Offer regulatory direction for remediation and suggestions concerning acceptability of suggests archiving in a timely manner.
• Write QMS SOPs connected to GxP audits which involves assisting documents.
• Guarantee and assist with the suitable escalation procedure to accountable management in case of crucial discoveries to mitigate possible compliance and business risk.
• You will serve as a GCP/PV compliance consultant for GxP connected trainings, task forces, and consistent improvement projects when required.
• Gather, assemble, and integrate input into the audit strategy and plan.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Educated to a degree level in a life science or similar field.
• At least 10 years of experience working in a pharmaceutical organisation with GMP/GDP tasks, mainly focussed on GCP/PV practices and regulatory needs.
• Familiarity working with GCP/PV audits and inspections.
• Past involvement in a GCP/PV lead auditor role.
• Willing to travel for business needs up to 40%-50% of the time.
• Knowledge of EU/US/RoW guidelines linked to GCP and GCP divisions, calculated by GMP guidelines.
• Comprehension of GMP principles.
• Communication skills both verbally and in writing.
• Expertise on document and record management within GxP linked computerised systems.
• Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Ieuan Phillips at +44 203 846 0643.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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