Description
Essential duties and responsibilities include but are not limited to the following: Incumbent will provide a QA oversight for the GxP computerized system validation activities. This individual must be self-motivated, have excellent interpersonal and customer service skills and the ability to build professional relationships.Requirements:
* Works with systems owners to ensure validation is conducted prior to deployment of GxP systems and systems are maintained in a validated state.
* Work closely with IT to ensure the company are meeting their relevant regulations, such as 21 CFR Part 11 and Annex 11
* Participate in system implementation project teams to ensure that required validation documentation is in place
* Assist with the authoring and review of validation documentation
* Working knowledge of how to effectively perform software validation in a regulated environment
* Broad knowledge of SDLC methodologies
* 5+ years relevant experience in computerized systems validation with preferably, at least 1 year in quality assurance role
* PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Education:
* Bachelor's degree in physical, life, or computer sciences or a related field
To find out more about Real please visit www.realstaffing.com