Our client is currently seeking a consultant to conduct an internal QMS audit. They would like someone who has experience conducting QMS audits for pharmaceutical, medical device or preferably cell therapy clients. This individual should have a history of conducting internal QMS audits as well as strong knowledge of 21 CFR Parts 210, 211, 820 & 600. There are templates in place for audit reports, however, the consultant can utilize their own as long as they are compliant with the client’s company standards. There are SOP’s that specify the format that the audit plan and report need to be in and there will be prior training on the company SOP’s prior to conducting the audit. The interview will go over examples of previous audit reports that the candidate has previous conducted. The audit itself will include, but will not be limited to observations of listing of conformities, narratives that describe what was examined and SOP’s that were examined, etc.
Educations: Bachelor’s Degree in related Life Sciences discipline
Location: Remote-based (virtual audit)
Duration: 2 day audit (some prep & post activities)
Start Date: Targeting December 5th (flexibility for start in mid or end-December)
Skills: Previous QMS internal audits, 21 CFR Parts 210, 211, 820 & 600
Remote: QMS Internal Auditor (232136)