Instagram
youtube
Facebook

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 currently seeking a full-time QA GCP Auditor to join our Quality Assurance team. This role will involve working collaboratively to accomplish tasks and projects critical to the company’s success. If you're looking for an exciting career where you can leverage your GCP expertise and develop a personalized career path, this opportunity is for you.

We are interested in office-based candidates located in London, Munich, Leuven, or Warsaw. Hybrid working options may be available depending on country policy after a six-month onboarding period.

Please submit applications in English.


Responsibilities:

  • Collaborate with Medpace operations to foster 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.
  • Coordinate, conduct, track, and resolve company-wide Corrective Action/Preventative Action (CAPA) investigations.
  • 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 within a related industry.
  • Experience with GCP site audits and vendor audits.
  • Excellent written and verbal communication skills.
  • Strong teamwork abilities and the capability to work independently.
  • Ability to travel approximately 50% across Poland.

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.