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Qa Gcp Auditor

2+ years
Not Disclosed
10 Oct. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: QA GCP Auditor


Job Summary:

Our European activities are expanding rapidly, and we are seeking a full-time QA GCP Auditor to join our Quality Assurance team. This position is essential for achieving tasks and projects critical to our company’s success. If you’re looking for an exciting career that leverages your GCP expertise while offering opportunities for personal growth, this is the role for you.

We welcome applications from candidates based in London, Munich, Leuven, or Warsaw. Hybrid working options are available after a six-month onboarding period.

Entry-level applicants are encouraged to apply.

Please submit applications in English.


Responsibilities:

  • Collaborate with Medpace operations to promote a culture of continuous improvement.
  • Coordinate and conduct internal system audits and external investigative site/vendor audits.
  • Create, maintain, and revise departmental Standard Operating Procedures, forms, and templates.
  • Develop training materials and applicable tests and guides.
  • Host sponsor audits and regulatory inspections.
  • Act as QA Project Leader, managing timelines and coordinating workloads among QA Auditors.

Qualifications:

  • Bachelor’s degree in life sciences or nursing.
  • 2+ years of experience in a QA department in a related industry preferred, but entry-level applications are welcomed.
  • Experience with GCP site audits and vendor audits preferred.
  • Excellent written and verbal communication skills preferred.
  • Strong teamwork abilities and the capability to work independently.
  • Proficiency in English and German.
  • Willingness to travel approximately 50% across Europe, including parts of the Middle East and Africa.

Medpace Overview:

Medpace is a full-service clinical contract research organization (CRO) providing 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 a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across major areas, including oncology, cardiology, metabolic disease, endocrinology, CNS, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.


Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

Our work over the past 30+ years has positively impacted countless patients and families facing various diseases. The efforts we make today will enhance the lives of individuals living with illness and disease in the future.


Medpace Perks:

  • Hybrid work-from-home options (dependent on position and level).
  • Competitive PTO packages.
  • Company-sponsored employee appreciation events.
  • Employee health and wellness initiatives.
  • Flexible work schedules.
  • Competitive compensation and benefits package.
  • Structured career paths with opportunities for professional growth.

Awards:

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
  • Continuously awarded CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.