Senior CSV-QA / SQA

Sr CSV-QA / SQA
Location: Remote
Duration: Consultant

Job description:

Sr CSV-QA / SQA Engineer will work with the team to ensure appropriate software validation & lifecycle documentation is in place to support changes to Laboratory and Product software systems. This role will provide value-added guidance throughout the software development lifecycle process.

PRIMARY RESPONSIBILITIES:

• Provide risk-based software validation guidance throughout the CSV process for custom and COTS software following GAMP 5, FDA 21 CFR part 11, Part 820, Annex 11 and GxP requirements.
• Represent software QA on development projects. Perform risk assessments at system and functional levels for computerized systems.
• CSV documentation review/approvals including Validation Plan, URS, FS, Design Specifications, System & Functional Risk Ass...