Quality Assurance Ecompliance Manager

Edelway is a Pan-European IT Consultancy. One of our best clients, a global, pharmaceutical company based in Basel is currently looking for experienced Quality Assurance Manager

LOCATION: Basel

YOUR ROLE

*Support QA eCompliance with project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements.
*Provide QA support for GxP impact computer system implementation projects
*Provide 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.
*Assist with the development and implementation of typical CSV related Standard Operating Procedures s and Working Instructions.
*Assist with the review and comment of existing IT CSV-related templates

YOUR PROFILE

*Experience in Pharma is a must
*Thorough understanding of Computer Validation
*Project management
*Min 5 years' experience of working in a QA role in a GxP environment
*Understanding of 21CFR, Part 11
*EU Annex 11
*Knowledge of current trends in industry related to data integrity
*GAMP 5 and its full lifecycle
*SAP

NICE TO HAVE

*Validation of cloud solutions a plus

If this sounds like your next challenge and you would like to know something more please send your CV to (see below) and I will contact you to discuss this shortly.