Senior Consultant, Compliance Services
PART TIME
DataCeutics


Position Description:

Specific responsibilities include:

 Performing all elements of the validation process;
 Developing and implementing validation plans;
 Conducting vendor audits and preparing audit reports;
 Performing assessment activities to formulate validation plans and 21 CFR Part 11 compliance plans;
 Executing validation plans and performing project management activities;
 Developing and writing SOPs;
 Developing test scripts and user acceptance tests and executing test scripts;
 Performing IQ/OQ activities;
 Preparing all validation / 21 CFR Part 11 reports, documents, and deliverables;
 Conducting validation and 21 CFR Part 11 training; and
 Contributing to the development of validation methodology and 21 CFR Part 11 compliance strategies

Requirements:
 Bachelor’s degree in computer science, life science or related field is preferred;
 3 plus years experience developing and implementing the validation process and validation deliverables;
 3 plus years Pharmaceutical or CRO industry experience with clinical systems;
 Systems or programming background;
 Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., ICH, GCP, validation, 21 CFR Part 11, etc.;
 Excellent interpersonal, communication, organizational, and project management skills; and
 Excellent presentation and writing skills