GxP Auditor (GMP/GDP/GLP)

Proclinical are recruiting a GxP Auditor (GMP/GDP/GLP) for a biotech corporation. This role is on a permanent basis with the ability to work remotely from anywhere in Europe. The client is focused on offering access to novel remedies that change the lives of those suffering from rare illnesses.

Responsibilities:

• Offer regulatory advice for remediation and suggestions concerning acceptability of suggested archiving in a timely manner.
• Guarantee and assist with the suitable escalation procedure to accountable management in case of crucial discoveries to mitigate possible compliance and business risks.
• The ideal candidate will assist with health authority inspections as well as eternal partner audits.
• Uphold expertise of company policies, SOPs, and assisting with documents linked to drug development/manufacturing/delivery.
• When required, you will serve as a GxP compliance consultant for GxP linked trainings, task forces and consistent improvement projects.
• You will form and examine vendor data as contributions into the audit method 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 technical and scientific field.
• At least 10 years of experience within a pharmaceutical organisation with numerous GMP/GDP duties.
• Field acquaintance working with GMP audits and HA inspections of sterile products, small molecules, medical devices, information systems, etc.
• Familiarity in a GMP/GDP/GLP lead auditor role.
• Expertise on EU/US/RoW guidelines in GMP manufacturing and release operations.
• Communication skills both verbally and in writing.
• Know-how of document and record management in GxP liked computerised systems, such as Trackwise, Veeva, MasterControl Sap, etc.
• Fluency in the English language with knowledge in ant other language(s) would be beneficial.
• Both internally and externally distribution focused.
• Works well in a team environment.
• A structured approach to working with a high attention to detail.
• Takes the initiative with the ability to resolve issues.
• An organised individual with the ability to handle various tasks simultaneously.

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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