Laboratory Quality Assurance Auditor

2-8-2020 heverlee
company profile

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing approximately 3,500 people across almost 40 countries.

Interested in this vacancy? Send me your resume and cover letter to anais.bosmans@cx.ausy.be or call 03 369 19 80 for more information.

job description

Have you always wanted to work for a worldwide CRO that is in full expansion? Would you like to grow with this company? Then take a look here!

Job duties will be adjusted based on experience and expertise of the candidate, and 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

your contribution

  • Bachelor’s degree in the 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 computerized systems
  • Good time management skills.

what do we offer?

WHY MEDPACE?

Finding work that is challenging, providing you with the tools and training to succeed, rewarding you for strong performance and providing the opportunity to grow professionally ... these are just a few reasons why talented and progressive people want to become part of the Medpace team.

summary
function
reviser / auditor (m/f)
employment type
full time
contract type
immediate permanent employments
reference
CXRSP-90465
your Randstad contact
Anaïs Bosmans
Anais_Bosmans@cx.ausy.be 03 369 19 81
03 369 19 81