Duration
12 months
Job Description
Our pharmaceutical client is looking for a consultant with a strong QA and GLP background, along with some GLP audit experience. Will be embedded in their quality systems, participating in team meetings, SOP reviews, resolving quality issue regulations affecting vendors, and also metric generation/review. Conduct GLP audits where records are very scientific in nature, along with quality/data focused reviews. 20% travel to CROs domestically. Regulatory document and high level report review. SOP review and bi annual collaborative review for current processes and process updates. Experience auditing both internal and external non-clinical/pre-clinical work. Roughly 90% will be non-clinical and 10% pre-clinical. Core background involves extensive QA and GLP experience with some audit background (this is not solely an audit role). Small molecule pharma is required with any cell/gene therapy or combination product being plusses. RQAP-GL certification is a plus. BS in science area required.
Skills
- QA, GLP, CRO, SOP, GLP Audit Pharma
Remote: GLP Consultant (232278)
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