Description
Job Requirements- The activities would include:
- Development and execution of the qualification of Information Technologies (IT) Infrastructure (i.e., servers, networks and network components) following the GAMP IT Infrastructure Guide.
- Development and execution of qualification & validation of Information Systems software (GAMP category 1, 2, 4 and 5) following GAMP5 guidance.
- Development of life cycle documents necessary to address the validation lifecycle (Planning, Risk, Implementation, and maintenance of the validated state).
- Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for equipment/systems.
- Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
- Ensure that appropriate Site Validation Listing is established and controlled.
- Review/Approval of all Computer Systems/Software Validation Documentation.
Qualifications
- Bachelor's degree in Computer Science, Computer Engineering, Computer Information Systems, plus 3 years relevant experience.
Experience
- Experience with the management, development and/or validation of Information Systems Technology projects is preferred.
- This experience may include but is not limited to the following: Windchill, TrackWise, Master Control, Agile PLM Software, Aegis, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testingetc.
- Prior experience in working with cGMPs and/or GLPs,and Quality Systems is preferred.
- Experience working in the Pharmaceutical / Medical Device industry.
Skills & Knowledge (must haves)
The ability to communicate IT/Validation concepts/strategies to project teams.
Be a self-starter and be motivated to provide a solid product quality and customer experience.
Be adaptable to a fast pace working environment
Be able to integrate and interact well within the customer environment.