Laboratory QA Auditor - Louvain

Vacancy information

Publication date:November 16 2020
Employment type: Permanent
Sector: Clinical Research
Function Group: Quality/RA

Function Group: Quality/RA / Quality Specialist

Organization

For a full-service clinical contract research organisation (CRO), we are currently looking for a Quality Assurance (QA) Auditor. The organisation provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. They leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.

Function

The QA Auditor will play an essential role in ensuring that the organisation upholds a standard for excellence by providing accurate, consistent, and reliable regulatory guidance. This position will report to the QA Manager and is based in Louvain, Belgium. Job duties will be adjusted based on experience and expertise of the candidate, these responsibilities may include:

  • Coordinating and conducting internal process audits and external vendor audits
  • Conducting instrument qualification and method validation audits
  • Hosting external sponsor audits and regulatory/accreditation (e.g. CAPA) inspections
  • Facilitating laboratory metrics, analysis, and reporting
  • Developing, conducting, and tracking company-wide applicable regulatory training
  • Facilitating Quality Event Management, including investigation, root cause analysis, CAPA development, effectiveness checks, tracking, and trending of quality events
  • Support with maintenance and development of a risk based Quality Management System, including creation, revision, or periodic review of Standard Operating Procedures
  • Support to continuous process improvement
  • Act as a consultant for laboratory personnel

Requirements

For this position, we are looking for someone with the following skillset:

  • Bachelor’s degree in science or a related field
  • One or more years of experience in a GxP regulated industry (GCP, GCLP, GLP, GMP)
  • Experience in quality assurance is a plus
  • Good regulatory knowledge (GCP, GLP or GCLP)
  • Experience in supporting or conducting audits in a laboratory environment
  • Excellent written and verbal communications skills in Dutch and English
  • Independent thinking and planning ability
  • Experience with a wide range of computerised systems
  • Good time management skills

Offer

If you are an independent, knowledgeable, and driven professional, the organisation can provide you with a competitive offer, and the opportunity to be an essential part of the organisation, please contact me for more details.

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Daniel Donker
Principal Consultant | Biotech & Pharma

+31(0)6-82564401
+31(0)23-7548660
d.donker@qtcrecruitment.com

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