Empleos actuales relacionados con Gcp Consultant - Los Alamos Colmenarejo - MMS

This role is a project-based consulting opportunity.

**Responsibilities**:

- Assist in vendor qualification of CROs, including preparing evaluation, quality agreements
- Vendor oversight and monitoring, as needed
- Experience with performing investigations of errors investigations and risk assessments
- Create controlled documents for compliance to regulatory requirements of the study planning, performance, final reporting
- Computer Software Validations/ eQMS implementation
- Implementation of eQMS systems including creating computer validation plans, assisting in testing of the system, and creating procedures for users, maintenance, and security of the system
- Experience with hosting and interacting with regulatory authorities during an inspection

**Requirements**:

- 10 years of experience in a GMP/ QMS role within the CRO, Pharma, or Biotech industry
- Bachelors Degree in a scientific, medical or clinical discipline
- Expert knowledge of scientific principles and concepts
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Excellent problem-solving skills
- Good organizational and communication skills
- Familiarity with current ISO 9001 and ISO 27001 standards preferred
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements
- Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process

lSf9wmtNqf