Job Summary
A medical device company needs applicants for an opening for a Telecommute Computer System Validation Lead.
Core Responsibilities Include:
- Supporting the project team through the day to day project activities under the supervision and direction of the Manager
- Reviewing and approving validation deliverables of GxP regulated computerized systems
- Supporting internal and external Health Authority regulatory audits
Skills and Requirements Include:
- Up to 30% domestic and international travel, depending on the location of the role
- A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required
- A minimum of 6 to 8 years of progressive experience in the pharmaceutical/medical device/biotech industry
- Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
- Strong QA analyst skills with experience in Computerized System validation in GxP environments is required
- Expert organizational skills are required