Aktualnie prowadzone rekrutacje

With offices in Berlin, Warsaw and Prague, KCR Placement is an international boutique provider of ‘fit for purpose’ resourcing solutions for a wide array of functions, including expert, managerial and senior executive ones. We specialize in finding the right talents for Pharmaceutical, Biotech, Medical Device companies and Contract Research Organizations across Europe. 


We're onboarding best-in-class candidates, so give us a chance to meet you!

Current Vacancy Highlights:

QUALITY ASSURANCE AUDITIOR / GERMANY

A leading Clinical Research Organization (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Quality Assurance Auditor. The new incumbent will be responsible for assessment of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of KCR projects, sites engaged, and vendors used to support clinical trials. The Quality Assurance Auditor will represent KCR while hosting external audits or inspections in the company’s Boston HUB.

 

 
Quality Assurance Auditor
 

 

 

Location: Germany
Type of Contract: Permanent

 

 

The duties associated with the role include:

  • Performs internal and external audits: including audits of documentation, investigator sites, vendors following Yearly Quality Assurance Plan
  • Prepares audit reports 
  • Acts as the company’s representative during external audits or inspections in KCR local HUB 
  • Handles Quality Management System by preparation, update and review of Standard Operating Procedures (SOPs), policies and guidelines 
  • Prepares and conducts external and internal ISO audits including: assistance with ISO re/certification, document verification, Quality Manual update
  • Assistance in Quality Assurance Plan preparation
  • Handles CAPA implementation in response to audits and inspection activities
  • Serves as a Subject Matter Expert for local policies, procedures and (FDA) regulations regarding clinical research operations
     

Requirements:

  • University/college degree 
  • Excellent command of English
  • Minimum of 2 years of relevant CRO experience in quality assurance area
  • Well-grounded knowledge of GCP, GMP, GLP regulations, ICH guidelines and clinical research process
  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and good working relationship with company personnel at all levels and with physicians and scientists from various disciplines
  • Sound judgement to evaluate discrepancies, make decisions and report findings
  • Deep understanding of processes in various areas of clinical project execution, ability to identify gap in the process and ability to provide alternative solutions to cover the process gaps, ability to handle confidential information diplomatically
  • Proficiency with computing software
  • Ability to manage work schedule in accordance with priorities
  • Ability to travel across the US to perform QA responsibilities
 
We’re onboarding “best in class” candidates, so give us a chance to meet you!

 

NOTE: When applying please kindly enclose the following statement:

"I hereby give my consent to the processing of my personal data included in the CV provided by me (within the scope beyond the contractual authorization), by KCR Placement Sp z o.o. on behalf of its clients with its seat in Warsaw (6 Postepu str, 02-676 Warsaw) as the data administrator, for the purposes related to the recruitment process conducted by the said entity. This consent also includes the processing of my personal data within the above scope in any future recruitment processes, unless the aim of such processing changes."

 

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