GxP Auditor (GCP/PV) job in Munich, Germany

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First Name*

Last Name*

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Phone Number*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: Germany

This vacancy has now expired. Please see similar roles below...

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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