About OnShore Technology Group

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.

OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.

Sr. Validation Lead

LOCATION:

Chicago, Illinois, USA

ABOUT THE POSITION

The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs. 

ROLES & RESPONSIBILITIES

EDUCATION & CERTIFICATION

REGULATORY KNOWLEDGE REQUIREMENTS

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