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This Computer System Validation (CSV) consultant role would use his/her knowledge of FDA cGMP, related regulations, and GAMP (Good Automated Manufacturing Practices) to develop and execute validation documentation for different computer systems, including SAS. This role is a mid to senior level role and will be onsite in Waltham, MA.
This role might be converted to a full time position if the resource also shows Quality skills and works well with the team.
Required Skills and Experience:
At least 3+ years of computer system validation experience is required.
Experience writing, reviewing, and executing computer system validation documentation, including but not limited to Validation Plans, IQ, OQ, PQ, Tracematrices, and Summary Reports.
Excellent writing and communication skills.
Experience working with Quality in an FDA-regulated environment.
Proficiency with MS Office Tools.
Experience with application of 21 CFR Part 11 and Annex 11.
Highly motivated self-starter and team player.
Experience with SAS CSV work is desired, but not required.
Job Type: Temporary