QA Ecompliance Contractor

Harvey Nash is looking for an 8 month project as QA eCompliance Contractor in Switzerland.

The role is for a candidate to support QA eCompliance with project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements.

You are responsible for

- providing QA support for GxP impact computer system implementation projects. This means ensuring that projects, systems, and processes, meet the requirements of the client quality manual
- providing excellent QA Operational support to IT departments. This includes assistance with GxP decision making, change control review and approval, SOP review and approval, and review/approval of other GxP related deliverables as needed
- assisting with the development and implementation of typical CSV related SOPs and WIs
- helping to drive Quality into IT business processes wherever possible
- assisting with the review and comment of existing IT CSV-related templates
- assisting with any other typical QA eCompliance responsibilities as required

Requirements
- B.S. in Computer Science, Engineering, or other similar scientific degree area
- 7 years in a GxP environment
- Thorough understanding of Computer Validation
- Thorough understanding of Validation of cloud solutions a plus
- Thorough understanding of 21CFR, Part 11
- Thorough understanding of EU Annex 11
- Thorough understanding of typical IT processes
- Thorough understanding of current trends in industry related to data integrity
- Thorough understanding of GAMP5 and its full life cycle
- Thorough understanding of Project management
- Thorough understanding of SAP
- At least 5 successful years working in a QA role in a GxP environment

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.