Auditor (Legacy Review): GMP, GCP, FDA. German and English*

Auditor (Legacy Review):GMP, GCP, FDA. German and English*

My outstanding Medical Device client in Switzerland is seeking an experienced Auditor to assist them with site audits and compliance processes. This project is completely unprecedented and therefore offers an amazing career opportunity.

*THE SUCCESSFUL CANDIDATE MUST BE ABLE TO SPEAK ADVANCED/FLUENT GERMAN AND ENGLISH*

Job description/Functional experience requirements:

*With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
*Audit sites' procedures to the standards and report out on findings (both current state and retrospectively.
*Make recommendations to achieve compliance where shortfalls are found.
*Provide Audit reports as directed.
*Perform CAPA root cause and corrective/preventive action as necessary.
*Perform CAPA verification of effectiveness as necessary.
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
*Analyzing reports NCR, CAPA files.
*Analyzing inspection activities.
*Analyzing maintenance reports and monitoring data.
*Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
*Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc

Knowledgethus, the validation requirement.
*The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
*The resource should have the ability to travel, to perform internal audits and be able to work independently - with minimal supervision

-Required degree/certificates:

*Degreed Engineer (Mechanical)

-Specific technical skills (please detail):

*Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.)

Specific knowledge for the role (please detail):
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.

Specific languages:
*FLUENT GERMAN/ENGLISH spoken and written

"Legacy Review" "auditor" "GMP" "GCP" "compliance" "FDA"