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Reference Number: sapvalidation
Job Description: Stelex provides full range Consulting, Validation and Auditing Services to the regulated industries including pharmaceuticals, medical device and diagnostics.
The Validation Consultant requires a Subject Matter Expert in SDLC validation. Validation experience for infrastructure (hardware, network, database and middleware) is desired.
Prior experience performing system validation in regulated industries such as pharmaceutical or device manufacturers.
Write, review and approve SDLC validation deliverables; extensive knowledge of 21 CFR Part 11 Requirements.
Prefer a working knowledge of Sarbanes Oxley (SOX) Regulations and experience ensuring the validation efforts mitigate potential SOX risks.
Experience with SAP as an end user, developer or validation support is required and SAP 4.7 or ECC 6.0 is desired.
Experience performing systems audits for compliance to SDLC methodology and regulatory requirements are preferred.
Please forward your resume as an attached MS Word document to jgardner@stelex.com
Stelex is an Equal Opportunity Employer.
Experience Level: Unspecified
Requirements: SAP validation experience in an FDA regulated environment.
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