IT Quality Assurance Subject Matter Expert (223845)
Life Sciences & Technology
A Black Diamond Networks client located in Canada is looking for an IT quality assurance (QA) subject matter expert (SME) who is available to provide three months of contract coverage with the strong possibility for an extension. The QA information technology SME will be responsible for the activity and quality systems needed to ensure that all GMP IT systems and associated documentation and operations are in full compliance with all regulations and standards. S/he will also be responsible for providing expertise and support through the interpretation of regulations, guidelines, and best practices for compliance of our client's GMP IT systems. Additionally, the consultant will provide cross-functional support to the production, QC, quality validation, and maintenance/engineering to support SDV activities for the site for both initial and requalification activities for instruments, equipment, and software implementation. Candidates interested in this position should have prior experience implementing/deploying SAP systems for GMP operations, from scratch and have a firm understanding of GAMP 5 and 21 CFR Part 11.