Responsibilities and Requirements :
- Must have knowledge and experience with GMP, Quality and compliance.
- Previous experience as a computer system validation / quality assurance for life sciences company regulated by the FDA is preferred.
- Experience in design of user requirement specifications, IQ / OQ / PQ protocols, user acceptance testing and other equipment / facility qualification documentation.
- Must be fluent in standard Microsoft Office software; experience in asset management software ( Blue Mountain RAM) and quality systems software ( Veeva).
- Drives use of best practices during IT systems design, validation, and use.
- Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
- degree required.
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